Metrohm TiNet 2.5 User Manual

CH-9101 Herisau/Switzerland
Internet www.metrohm.com
E-Mail [e-mail]

TiNet 2.5 Compliant

6.6012.X50

Metrodata

8.110.8353 Instructions for Use

08.08.2003 / dö

What's new in TiNet 2.5 SR1?

General

- TiNet 2.5 can be installed in one of the two following versions:

• TiNet 2.5

Basic version of TiNet. Except for some new devices (see below), this version is
identical to TiNet 2.4 and will be described in the 8.110.8243 "TiNet 2.4/2.5"
Instructions for Use.

• TiNet 2.5 Compliant

Extended version of TiNet, which can be configured and run in order to comply
with 21 CFR Part 11. In this program version, password protection, user
administration, electronic signatures, Audit Trail, and method and determination
administration in a database are integrated. The new and different features of this
version compared to TiNet 2.5 are described in these Instructions for Use.

- You can always use methods and data created by older TiNet versions.

Devices

- The 794, 795, 798, and 799 Titrinos can be fully controlled by TiNet.

- The 831 KF Coulometer can be fully controlled by TiNet.

- The 778, 789 and 824 Sample Changers can be fully controlled by TiNet (details see
Online-Help).

All Rights Reserved.

Printed in Switzerland by Metrohm AG, CH-9101 Herisau ©2003

Contents

1. Overview .......................................................................5

1.1 Overview of TiNet 2.5 Compliant........................................................5

1.1.1 Purpose of program..........................................................................5

1.1.2 Program parts...................................................................................6

1.1.3 Program sub-directories...................................................................6

1.1.4 General information ..........................................................................7

1.2 Program installation............................................................................ 8

1.2.1 System requirements........................................................................8

1.2.2 Installation of TiNet 2.5 Compliant....................................................8

1.2.3 Installation of the Dongle ................................................................10

1.2.4 Deinstallation of TiNet.....................................................................10

2. Connection of devices and configuration..................11

2.1 Connection of devices ...................................................................... 11

2.2 Configuration.....................................................................................11

2.3 Special settings.................................................................................11

3. Program settings ........................................................13

3.1 Security policies................................................................................ 13

3.1.1 Options for Login/Password protection..........................................13

3.1.2 Audit Trail settings...........................................................................15

3.1.3 Define default strings......................................................................15

3.2 User administration........................................................................... 16

3.2.1 User groups ....................................................................................16

3.2.2 Access policies...............................................................................17

3.2.3 Electronic signatures ......................................................................18

3.2.4 Users............................................................................................... 18

3.3 Login/Logout .....................................................................................19

3.3.1 Login ...............................................................................................19

3.3.2 Logout.............................................................................................20

3.4 Options .............................................................................................. 21

3.4.1 Curve settings.................................................................................21

3.4.2 Print options....................................................................................22

3.4.3 Export settings ................................................................................23

3.4.4 System name.................................................................................. 24

3.4.5 Database options............................................................................25

TiNet 2.5 Compliant Contents • i

4. Methods ......................................................................27

4.1 General information on methods......................................................27

4.1.1 Draft methods................................................................................. 27

4.1.2 Database methods......................................................................... 27

4.2 Draft methods....................................................................................28

4.2.1 Create new method........................................................................ 28

4.2.2 Edit existing methods..................................................................... 28

4.2.3 Set method directory...................................................................... 28

4.3 Database methods.............................................................................29

4.3.1 Method administration.................................................................... 29

4.3.2 Save method in database .............................................................. 31

4.3.3 Sign method ................................................................................... 32

4.3.4 Export method................................................................................ 32

4.3.5 Method report................................................................................. 33

4.3.6 Delete method................................................................................ 33

4.3.7 Use signed methods only ..............................................................34

5. Titrations.....................................................................35

5.1 Main window......................................................................................35

5.1.1 Overview......................................................................................... 35

5.1.2 Menu items..................................................................................... 36

5.2 Sample data.......................................................................................38

5.2.1 Sample data entry .......................................................................... 38

5.2.2 View for sample data...................................................................... 40

5.3 Silo memory.......................................................................................41

5.3.1 Display silo memory ....................................................................... 41

5.3.2 Edit silo memory............................................................................. 42

5.3.3 Load, save, and delete silo ............................................................ 44

5.3.4 View results..................................................................................... 44

5.4 Performing titrations .........................................................................46

5.4.1 Preparing single determinations ....................................................46

5.4.2 Preparing sample series................................................................. 46

5.4.3 Buttons for titrations .......................................................................46

5.4.4 Working with connected balance................................................... 47

5.4.5 Karl Fischer titrations...................................................................... 47

5.4.6 Live titration curves......................................................................... 49

5.4.7 Emergency stop ............................................................................. 49

5.5 Parallel titrations ...............................................................................50

5.5.1 Add parallel titration........................................................................ 50

5.5.2 Remove parallel titration................................................................. 50

5.5.3 Rename parallel titration................................................................. 50

ii • Contents TiNet 2.5 Compliant

6. Results ........................................................................51

6.1 General information on determination data.....................................51

6.2 TiNet database .................................................................................. 51

6.3 Results overview...............................................................................52

6.3.1 Display of results.............................................................................52

6.3.2 Columns of the results overview table............................................54

6.3.3 Show PDF report.............................................................................55

6.3.4 Print result report.............................................................................56

6.3.5 Sign result .......................................................................................57

6.3.6 Export result.................................................................................... 58

6.3.7 Delete result....................................................................................58

6.3.8 Column view for results overview ...................................................59

6.3.9 Edit filter for results .........................................................................60

6.3.10 Apply filter for results.....................................................................60

7. Working according to 21 CFR 11................................61

7.1 Program settings............................................................................... 61

7.1.1 First login.........................................................................................61

7.1.2 Security policies..............................................................................61

7.1.3 Addition of new administrators.......................................................62

7.1.4 Addition of user groups and users .................................................63

7.1.5 Print options....................................................................................63

7.2 Configuration of devices...................................................................64

7.3 Methods.............................................................................................64

7.3.1 Create new draft methods ..............................................................64

7.3.2 Save methods in the method database .........................................64

7.3.3 Sign methods..................................................................................65

7.3.4 Restrict method selection ...............................................................66

7.4 Results...............................................................................................66

7.4.1 Sign results .....................................................................................66

7.4.2 Show and print result reports..........................................................67

7.5 Audit Trail ..........................................................................................68

7.5.1 Display Audit Trail ........................................................................... 68

7.5.2 Export Audit Trail............................................................................. 69

7.5.3 Delete Audit Trail............................................................................. 70

7.5.4 Column view for Audit Trail .............................................................70

TiNet 2.5 Compliant Contents • iii

8. Appendix .....................................................................73

8.1 Software license ................................................................................73

8.2 Declaration of conformity – Software validation..............................74

8.3 Accessories .......................................................................................75

8.3.1 Standard equipment....................................................................... 75

8.3.2 Options ........................................................................................... 75

9. Index ...........................................................................76

iv • Contents TiNet 2.5 Compliant

1. Overview

1.1 Overview of TiNet 2.5 Compliant

1.1.1 Purpose of program

The name "TiNet" is derived from Titration Network. TiNet 2.5 Compliant is
a comprehensive program package for titrations. It offers the following
possibilities:

• Several Titrinos, KF Coulometers, Sample Changers, Dosimats and
Conductometers can be used in a single method.

• IF conditions, messages and requests can be incorporated in the
method sequence.

• The layout of reports can be designed.

For the performance of the determinations, you use the main window.
Here, you control and monitor all important data.

• You can enter sample data manually or via a connected balance.

• Sample data can also be entered for future use in (different) sample

data memories (silos).

• You are shown the status of the sample processing.

• Live Titration curves are displayed.

• You can also perform several determinations at different wet work-

stations simultaneously (parallel titrations).

TiNet 2.5 Compliant can be installed, configured and used in order to
comply to the requirements for using electronic documentation and signa­tures according to 21 CFR Part 11. For this purpose, the program contains
password protection, user administration, electronic signatures, Audit Trail
and administration of methods and results in databases.

TiNet 2.5 Compliant Overview • 5

1.1.2 Program parts

Instead of the TiNet panel of previous program versions, TiNet 2.5 Com­pliant comprises a new main window for performance of determinations.
From this main window, the other independent program parts can be
called up:

TiNet 2.5 Compliant

Main window of TiNet. Here you handle your daily work: You start ti­trations and enter sample data (see section 5.1).

TiNet 2.5 – Configuration

Here you register the connected devices, as well as manage com­mon variables and calibration data (see section 2).

TiNet 2.5 – Methods

Here you edit new or existing draft methods (see section 4).

Method administration

Here you organize method versions in the method database accord­ing to 21 CFR 11 (see section 4.3).

Results

Here you can view and print the original results stored in the result
database according to 21 CFR 11 (see section 6.3).

TiNet 2.5 – Results

The titration results are also stored (not according to 21 CFR 11) in
the so-called "TiNet database". Here, you can display, sort, view and
recalculate your data (see section 6.2).

1.1.3 Program sub-directories

The installation program copies the files from the installation CD to the
drive and directory you specify and creates the following sub-directories:

..\Bin Includes all files needed for the program package.

..\Data Default directory for method, result and Audit Trail data-

bases.

..\Database Default directory for the TiNet database of the program

part "Results".

..\Doc

..\Export Default directory for data exported.

..\Methods

Includes several PDF documents concerning TiNet.

Default directory for draft methods.

..\Methods\Standard

Includes the TiNet standard methods.

..\Results

Default directory for the raw results generated during the
course of the methods.

..\Silo

..\Tmp

Default directory for silo memories.

Default directory for PDF report files.

6 • Overview TiNet 2.5 Compliant

1.1.4 General information

Help

You can use the <F1> key to request context-sensitive help for the cur­rent topic anywhere in the program.

Magenta texts always identify the dialog point in the corresponding win-

dow. In some cases, the color is also used to highlight
important information.

Green texts You can click on these texts to branch to other Help top-

ics.

You will always find these two buttons in the toolbar of the

program parts. If you press <?>, the list of contents of
Help appears for the corresponding program part. With
<Ñ?> you obtain direct help on the individual (menu)
items. Click the button. The pointer is now shown as a ?.
Move this pointer to the point on which you require help.

Backup

You should back up your data at regular intervals using a long time archiv­ing system.

Select the following sub-directories for backup:

Data (method, result and Audit Trail databases)

•

Database (TiNet database)

•

Methods (draft methods)

•

Results (raw results which have not yet been read into the database)

•

Silo (sample data memories)

•

Tmp (PDF files)

•

TiNet 2.5 Compliant Overview • 7

1.2 Program installation

1.2.1 System requirements

Computer recommended Pentium processor

Operating system Windows 98/Me, Windows NT 4.0,

Windows 2000 (recommended), Windows XP

Disk space Program: min. 30 MB on hard disk

Data: min. 150 MB

RAM recommended 32 MB

ComPorts 1 free COM port per connected device

LPT 1 free LPT per connected Sample Changer with 664

Control Unit

1.2.2 Installation of TiNet 2.5 Compliant

Note: Start directly with Step 5, if you do not want to generate and print
PDF reports.

1. If the Adobe Acrobat Reader program is not already installed on the
computer, open the Acro5/English directory for Adobe Acrobat Reader
installation on the installation CD and start the

2. After completion of the installation, open Acrobat Reader, accept the
contract, open a PDF file, print it, and close Acrobat Reader.

3. Open the
printer driver installation on the installation CD. According to your op­erating system, open the

*.exe file.

4. Click on <Setup> and confirm the installation procedure with <Yes>.

Important: The installed printer driver "FinePrint pdfFactory Pro" is a
shareware version with all functions, which creates a message on
each report. If you like to print reports without this message, the full
version of "PDF Factory Pro" must be purchased. You will find ordering
information on www.fineprint.com/company/resellers.html.

PDFFact/English directory for Fineprint PDFFactory Pro

95_98_ME or NT2000XP directory and start the

*.exe file.

5. Install TiNet 2.5 from the installation CD and proceed according to the
installation wizard until the window Installation versions appears.

8 • Overview TiNet 2.5 Compliant

6. Select the option
on

Next>.

7. Select the installation directory and click on

TiNet 2.5 Compliant (with 21 CFR 11 features) and click

Next>. The "TiNet 2.5

Compliant" program will be installed.

8. Click on

9. Open the TiNet 2.5 Compliant program. The

Finish> to complete the installation.

Login window appears

(see section 7.1.1).

10. Enter "

Admin" for User name and "TiNet2" for Password. Click on <OK>.

11. Select Extra/Options/Print options to open the Print options window (see
section 3.4.2).

12. In the
tion and select the

Print options for TiNet reports box, enable the Special printer op-

FinePrint pdfFactory Pro printer driver.

13. Select the directory to which PDF reports will be saved. There must be
no ‘.’ (dot) in the whole path!

14. Select a

Delay for the PDF creation. It is not recommended to select

shorter times than 45 sec. Note that this is the minimum method dura­tion time (add a WAIT block to the method if the duration time is
shorter than this delay)!

15. Enable or disable the option for immediate printing of PDF reports.
This requires the installation of Adobe Acrobat Reader (see Step 1).

16. Click on

<OK> to close the Print options window and close the pro-

gram.

17. Create a new method containing a WAIT block (waiting time 60 s), a
CALC block (with a calculation formula "RS = SmplSize") and a
REPORT block (text field, "Print immediately" activated).

18. Start the method.

19. If you are working with a NTFS file system, make sure that all Windows
users have read and write privileges for all subdirectories of the pro­gram directory, for the method directory, for all export directories de­fined in the program and for C:\ and the two files

TINET2.INI in the Windows directory.

WIN.INI and

TiNet 2.5 Compliant Overview • 9

20. Make sure that all Windows users have read and write privileges for
the following registry keys and subkeys (use
and modify the permissions):

a. HKEY_CURRENT_USER\Software\FinePrint Software\pdfFactory
b. HKEY_LOCAL_MACHINE\Software\Classes\Tinet2
c. HKEY_LOCAL_MACHINE\Software\Metrohm\TiNetCom
d.

HKEY_LOCAL_MACHINE\Software\Adobe

f.

HKEY_LOCAL_MACHINE\Software\PDFReport (only displayed after

first PDF printout)

HKEY_CLASSES_ROOT (write privileges)

g.

21. Restart the computer.

22. Please send us your registration card as soon as possible so that we
can register you as an official user of TiNet. Only registered users will
get updated program versions at a special price.

1.2.3 Installation of the Dongle

The 6.2145.000 or 6.2145.060 Dongle is part of the scope of delivery of
the full program versions. Set this Dongle on LPT-Port 1 or 2 (if possible
on the LPT Port where you connected the printer, not on the Sample
Changer Port). The printer cable is set onto the Dongle. Starting TiNet, the
Dongle will be checked.

REGEDT32.EXE to view

If you set the dongle onto a different LPT after installing TiNet, proceed as
follows:

• Close TiNet.

• Start the

• Select the

iniedit.exe program in the Bin directory of TiNet.

Miscellaneous tab and click on <Apply>.

If you make an update of an older version of TiNet, first set the dongle
on the LPT (see above) before you start TiNet. Do not
"4COM card" during the installation.

A demonstration version can be used for 100 days. After this 100 days
you may continue to use the program, but you cannot start any determina­tion. You can upgrade your demonstration version at any time if you set a

6.2145.000 or 6.2145.060 Dongle on the LPT Port of your computer.

Note: The use of TiNet 2.5 Compliant without dongle as demo version

is not recommended.

1.2.4 Deinstallation of TiNet

click the option

After uninstalling TiNet you will get a dialog with the button <Detail>. Here
you will find a list of directories which could not be deleted.

10 • Overview TiNet 2.5 Compliant

2. Connection of devices and configuration

2.1 Connection of devices

You will find detailed information on connecting devices and adding addi­tional interfaces in the 8.110.8243 Instructions for Use "TiNet 2.4/2.5",
section 2.

2.2 Configuration

You will find detailed information on the lists of devices, calibration data
and common variables in the 8.110.8243 Instructions for Use "TiNet

2.4/2.5", section 5.

2.3 Special settings

You will find detailed information on the special settings which can be set
by the INIEDIT.EXE program in the 8.110.8243 Instructions for Use "Ti-
Net 2.4/2.5", section 9.

TiNet 2.5 Compliant Connection of devices and configuration • 11

12 • Connection of devices and configuration TiNet 2.5 Compliant

3. Program settings

3.1 Security policies

TiNet 2.5 Compliant, Extra, Security policies

This menu item opens the Security policies window for definition of login
options, password protection, Audit Trail, electronic signatures and default
strings.

3.1.1 Options for Login/Password protection

Settings according to 21 CFR 11:

<Apply> sets all login and password options to default settings

according to 21 CFR Part 11.

Login policies

Enforce login with user name ([on], off)

If this option is enabled, every user must enter her/his user
name in the Login window at every program start. If this option
is disabled, no login is required. The following login and pass­word policies are meaningless and will be set to inactive (gray).

TiNet 2.5 Compliant Program settings • 13

Enforce login with password ([on], off)

If this option is enabled, every user must enter user name and
password in the Login window at every program start. If this op­tion is disabled, no login is required. The following login and
password policies are meaningless and will be set to inactive
(gray).

Maximum number of login attempts ([on], off); 2...[3]...6)

If this option is enabled, a user is set to "inactive" as soon as the
maximum number of login attempts is exceeded. The counter
for login attempts is set to zero for all users at every new start
of the program.

Automatic logout after ([on], off); 1...[10]...60 min)

If this option is enabled, the user is logged out automatically if
no operating function via mouse or keyboard is done during
the defined delay time.

New login only for the same user ([on], off)

If this option is enabled, only the same user can login after
automatic logout. In any case, user with administrator privi­leges can always login.

Password

Enforce unique password ([on], off)

If this option is enabled, passwords must be unique. Expired
passwords are treated like active passwords, so every pass­word can only be used once.

Enforce use of special characters ([on], off)

If this option is enabled, a password must contain at least one
special character.

Minimum password length ([on], off; 1...[6]...40 characters)

If this option is enabled, the password must have the set num­ber of characters.

Passwords expire every ([on], off; 1...[365]...999 days)

If this option is enabled, a new password must be entered after
the expiration time.

14 • Program settings TiNet 2.5 Compliant

3.1.2 Audit Trail settings

Settings according to 21 CFR Part 11:

<Apply> sets all Audit Trail options to default settings accord-

ing to 21 CFR Part 11.

Enable Audit Trail ([on], off)

If this option is enabled, all program actions defined as Audit
Trail actions are registered automatically in the Audit Trail data­base.

3.1.3 Define default strings

Category: Selection of the category, for which default strings can be de-

fined.

Add new default string. The window for entering default strings
is opened.

TiNet 2.5 Compliant Program settings • 15

Modify selected string. The window for edition of default strings
is opened.

Delete selected string.

3.2 User administration

TiNet 2.5 Compliant, Extra, User administration

This menu item opens the User administration window for administration of
user groups and users and their access rights and signature policies.

3.2.1 User groups

If a user group is selected in the left part of the User administration window,
details on this user group and a table with all group members (User name,

Full name und State) are shown in the right part.

Group name:

Name of the user group. This name must be unique. The name

16 • Program settings TiNet 2.5 Compliant

can also be edited by clicking the group name field in the ex­plorer part.

Description:

Description of the user group.

Group has administrator policies

If this option is enabled, the user group has administrator poli­cies. This option must be enabled for at least one group.

After clicking the group name field in the explorer part with the right mouse
key, user groups can be created and deleted:

New group

Create new user group.

Delete group

Delete selected user group. The group can only be deleted if it
has no users any more.

3.2.2 Access policies

If the

Access policies element is selected in the left part of the User admini-

stration

window, access policies for this user group are shown in the right
part and can be modified. Every menu item of the TiNet 2.5 Compliant
main window can be enabled or disabled.

TiNet 2.5 Compliant Program settings • 17

3.2.3 Electronic signatures

If the Signatures element is selected in the left part of the User administra-

tion

window, the authorization for signature of methods and results for this

user group are shown in the right part and can be modified.

Authorized to release with signature

If this option is enabled, user of this user group are allowed to
sign methods or results.

3.2.4 Users

18 • Program settings TiNet 2.5 Compliant

If a user from a user group is selected in the left part of the User administra-

tion

window, details on this user are shown in the right part.

User name:

Short name of the user which must be entered for

Login window. This name will be enclosed in the report.

the

Full name: Full name of the user with possibility for additional information

User name in

(e.g. title, address, etc.).

State: Current user state (active, inactive, removed). The administrator

is allowed to change the user state.

User group:

Current user group. The administrator is allowed to change the
group for the user. If this is done, the user icons are automati­cally transferred to the new group.

Remarks: Possibility to enter additional user information.

<Reset password>

Possibility to reset the password for the user to the original start
password (identical to the User name), which must be changed
immediately at first login.

After clicking into the explorer part with the right mouse key, users can be
created and deleted:

New user Add new user to user group.

Delete user

Delete selected user from the user group and transfer to the

Removed users group.

3.3 Login/Logout

3.3.1 Login

TiNet 2.5 Compliant Program settings • 19

If password protection is enabled on the Security policies tab, the Login
window appears at every new start of TiNet or after Logout. In this window,
you have to login by entering user name and password.

User name

Enter your user name (capitals are ignored).

Password Enter your password (capitals must be identical!). At first login,

Password is identical to the User name, but it must be

the
changed immediately.

Click this button to change your password.

Old password:

Enter your old password.

New password:

Enter the new password.

Confirm password:

Confirm the new password.

3.3.2 Logout

By clicking this button the current user is logged out. At the same time, the

Login window for login of a new user appears on the screen.

20 • Program settings TiNet 2.5 Compliant

3.4 Options

3.4.1 Curve settings

TiNet 2.5 Compliant, Extra, Options, Curve settings

This menu item opens the Curve settings window. You can define here how
to display live titration curves on the device tabs in the main window.

Device selection

Selection of the device for which the curve settings will apply.

Block selection

Selection of the block (e.g.
will apply.

Measuring unit selection

Selection of the measuring unit (e.g. pH, U) for which the curve
settings will apply.

X axis

Quantity

Selection of the quantity which will be displayed on the X axis:
Volume (V/ml), Time (t/s), Measured value (Meas), ERC (only for
DET titrations; first derivative multiplied with a logarithmic fac­tor), Meas & ERC (both curves), Temp (Temperature in °C).

Autoscale

Automatic scaling.

Fixed from...until

Fixed scaling.

MET, DET) which the curve settings

TiNet 2.5 Compliant Program settings • 21

Y axis identical to X axis.

Grid Display of grid lines.

3.4.2 Print options

TiNet 2.5 Compliant, Extra, Options, Print options

This menu item opens the Print options window for report output settings.

Note: Reports are only created automatically in the method sequence if
the

Print immediately option in the Report block is enabled.

Print options for TiNet reports

Printer selection für TiNet report printing:

Default printer

Windows default printer (display only).

Special printer

Selection of a printer configured for Windows. In order to create
automatically PDF reports from TiNet reports, the "FinePrint

pdfFactory Pro

Print options for PDF reports

Save PDF reports in

" printer must be selected.

Selection of the directory to save the automatically generated
PDF reports.
Note: No point (.) is allowed in the whole directory path.

22 • Program settings TiNet 2.5 Compliant

Delay Delay time for PDF report generation. It is recommended to set

a minimum delay of 45 s.

Immediately print PDF reports after creation

If this option is enabled, the PDF reports are printed on the se­lected printer. If this option is disabled, the PDF reports are
only saved.

3.4.3 Export settings

TiNet 2.5 Compliant, Extra, Options, Export settings

This menu item opens the Export settings window. You can define here
how to export data from the result database.

Export directory

Directory

Selection of the directory to which data will be exported.

Export file name

Definitions for export file name.

File extension

File extension for export file.

TiNet 2.5 Compliant Program settings • 23

Fixed file name (data records are appended)

If this option is enabled, the data of the selected determinations
will be appended in one file. The name for this file can be en­tered in the field on the right side.

Automatic file name (made of date and time)

If this option is enabled, a separate file is created for each de­termination selected. The name for these files are generated
automatically from date and time of the determination.

Example

Display of an example name with set parameters.

More settings

Separator

Selection of character for separation of field contents. Available
characters: " ; " , ", "

Field selection

Click on
lect here the fields of the result overview table which will be ex­ported.

Automatic export

If this option is enabled, the data will be exported automatically
at the time the determination data are saved in the result data­base.

Export raw data (*.dta)

If this option is enabled, the raw data of the selected determi­nation will be saved in a *.dta file. The name of this file will be
generated automatically from date and time of the determina­tion.

Export method (*.mth)

If this option is enabled, the method used for the selected de­termination will be saved in a

TAB " and " SPACE".

to open the Field selection window. You can se-

'Method name'.mth file.

3.4.4 System name

TiNet 2.5 Compliant, Extra, Options, System name

This menu item opens the System name window where the name to be en­tered as System name in the Audit Trail (see section 7.5.1) can be defined.

24 • Program settings TiNet 2.5 Compliant

3.4.5 Database options

TiNet 2.5 Compliant, Extra, Options, Database options

This menu item opens the More options window. You can define here
where to save method, result and Audit Trail database. It is also used to
pack databases.

Database directory

Save databases in

Selection of the directory for saving method, result and Audit
Trail databases.
Note: Make sure that every user has permanent read/write
privileges for this directory!

Packing databases

Select database

Selection of the database to be packed.

<Pack database>

Start packing.

Process progress

Display of packing progress.

TiNet 2.5 Compliant Program settings • 25

26 • Methods TiNet 2.5 Compliant

4. Methods

4.1 General information on methods

Two different types of methods are used in TiNet 2.5 Compliant: Draft
methods and Database methods.

4.1.1 Draft methods

Draft methods are stored as files in the Methods directory. Only these
methods can be edited in the

signed methods only

perform determinations. In this case, the requirements for working accord­ing to 21 CFR Part 11 are not met.

You will find detailed information on edition of draft methods in the

8.110.8243 Instructions for Use "TiNet 2.4/2.5", section 6.

option is disabled, draft methods can also be used to

TiNet 2.5 – Methods program part. If the Use

Note:

Start and end sequences are ignored with TiNet 2.5 Compliant.

4.1.2 Database methods

Draft methods can be saved in the method database as Database meth­ods. At every saving procedure, a new method version is created. The

user must enter a comment for each method version. In order to use da­tabase methods they must be signed electronically and given a signature
comment. In addition to this, the Use signed methods only option must be
enabled. If you use database methods, the requirements for working ac­cording to 21 CFR Part 11 are met

A method version of the method database must be copied as draft
method before it can be edited. If already present, an existing draft
method with the same name is overwritten. Once the method has been
modified, it must be saved again in the method database as a new
method version.

You will find detailed information on edition of draft methods in the

8.110.8243 Instructions for Use "TiNet 2.4/2.5", section 6.

.

TiNet 2.5 Compliant Methods • 27

4.2 Draft methods

4.2.1 Create new method

TiNet 2.5 Compliant, Extra, Methods, New method

This menu item opens the TiNet 2.5 / Methods program part, where a new
method can be created.

You will find detailed information on edition of draft methods in the

8.110.8243 Instructions for Use "TiNet 2.4/2.5", section 6.

4.2.2 Edit existing methods

TiNet 2.5 Compliant, Extra, Methods, Edit method

This menu item opens one of the draft methods available in the current
method directory in the TiNet 2.5 - Methods program part.

Method administration, Draft methods, Edit method

This context-sensitive menu item opens the selected draft method in the

TiNet 2.5 - Methods program part.

You will find detailed information on edition of draft methods in the

8.110.8243 Instructions for Use "TiNet 2.4/2.5", section 6.

4.2.3 Set method directory

TiNet 2.5 Compliant, Extra, Methods, Method directory

This menu item opens the Select directory window for selection of the di­rectory for draft methods. You will find existing default methods in the

..\Methods\Standard directory.

28 • Methods TiNet 2.5 Compliant

4.3 Database methods

4.3.1 Method administration

TiNet 2.5 Compliant, Extra, Methods, Method administration

This menu item opens the Method administration window for display of all
draft methods and database methods with its versions.

Current method directory

Display of the current directory for draft methods. TiNet has
more than 40 prepared default draft methods in the

..\Methods\Standard directory.

Draft methods

Display of the draft methods available in the current methods
directory. By clicking a draft method with the right mouse key
the following functions can be triggered:

Save method in database (see section 4.3.2)
New method (see section 4.2.1)

Edit method

Database methods

(see section 4.2.2)

Display of the methods in the method database. By clicking a
database method with the right mouse key the following func­tions can be triggered:

Copy method to editor

The database method is copied as draft method into the
method directory.

Show method

The database method is opened as draft method but cannot
be edited.

Sign method (see section 4.3.3)

TiNet 2.5 Compliant Methods • 29

Export method (see section 4.3.4)

Method report

Delete method

Current versions

On this tab, the current versions of the available database
methods are shown. The table on this tab has the following
columns:

Method name

Name of database method.

Version

Version number of database method (stored as Id8 for deter­minations).

Creator

User name of the user who saved the database method.

Creator name

Full name of the user who saved the database method.

Creation date

Date and time when the database method was saved.

Signer

User name of the last user who signed the database method.

(see section 4.3.5)
(see section 4.3.6)

Signer name

Full name of the last user who signed the database method.

Sign date

Date and time when the database method was signed.

Sign comment

Comment entered at signing the database method.

Former versions

On this tab, the former versions of the available database
methods are shown. With the exception of the method name,
which is shown above the table, the table has the same col­umns as the
version to the current version, it must be copied first as draft
method with Copy method to editor and then saved again as a
new version in the method database with Save method in data-

base

.

Modification comment

On this tab, the comment entered at saving of the database
method is shown.

Current versions tab. In order to convert a former

30 • Methods TiNet 2.5 Compliant

4.3.2 Save method in database

Method administration, Draft methods, Save method in database

Using this context-sensitive menu item, a draft method can be saved in
the method database. Before the method is saved, the

method modification

window appears:

Comment on

Method:

Method name (display only)

Version:

Automatically set version number (display only)

Description:

Selection of a default string or entry of a user-specific text.

Comment:

User-specific comment for description of method modifica­tions.

Afterwards, the method can be signed.

TiNet 2.5 Compliant Methods • 31

4.3.3 Sign method

Method administration, Database methods, Sign method

Using this context-sensitive menu item, a database method can be signed
electronically. The

Sign-off window appears, containing the following fields:

User name

Name of the user who wants to sign the method.

Password

Password of the user who wants to sign the method.

Meaning

User-specific comment to the signature.

By clicking on

<Sign-off>, these data are saved in the method database.

Signature data already present is always overwritten by the new signature
data.

4.3.4 Export method

Method administration, Database methods, Export method

Using this context-sensitive menu item, a database method can be ex­ported. The Select directory window appears for selection of the export di­rectory. With <OK>, the method is saved as method file (*.mth) and the
application note as text file (*.txt) in this directory.

Exported methods can be imported into a method database using the

Save method in database menu item.

32 • Methods TiNet 2.5 Compliant

4.3.5 Method report

Method administration, Database methods, Method report

Using this context-sensitive menu item, a report of the selected database
method is printed on the default printer. This report contains the following
entries:

Method name:

Method name

Method version:

Version number of the method

Saved by:

Full name of the user who saved the method in the method da­tabase.

Saved on:

Date and time of saving the method.

Signed by:

Full name of the user who signed the database method.

Signed on:

Date and time of signing the method.

Sign comment:

Comment to signature.

Report printed on:

Date and time of printing the report.

4.3.6 Delete method

Method administration, Database methods, Delete method

Using this context-sensitive menu item, the selected database method
can be deleted.

After confirmation of the deleting action, the Delete method window opens,
where two administrators must confirm the deletion by entering user name
and password.

TiNet 2.5 Compliant Methods • 33

4.3.7 Use signed methods only

TiNet 2.5 Compliant, Extra, Methods, Use signed methods only

This option ensures that only signed database methods can be used to
perform determinations. It must be enabled to to be compliant according
to 21 CFR 11.

34 • Methods TiNet 2.5 Compliant

5. Titrations

5.1 Main window

5.1.1 Overview

The main window "TiNet 2.5 Compliant" is the working window where you
can make the necessary entries for your determinations, enter sample
data for single determinations and sample series, start and stop your
methods, and show live titration curves using the following elements:

• Menu items (see section 5.1.2)

• Tab for sample data entry

• Tab for silo memory

• Buttons for titrations

• Display of application note

• Tabs for parallel titrations (see section 5.2)

• Tabs for live curves (see section 5.X)

TiNet 2.5 Compliant Titrations • 35

5.1.2 Menu items

File

Load silo Opens an existing file with silo data (see section 5.3.3).

Save silo Saves an open silo file under the same or a new name (see

section 5.3.3).

Delete silo Deletes a silo file (see section 5.3.3).

Add parallel titration Adds a new tab with a parallel titration (see section 5.5.1).

Remove parallel titration Removes the tab with the parallel titration added last (see

section 5.5.1).

Exit Exits the "TiNet 2.5 Compliant" program.

Edit

Cut Deletes data and transfers this data to the clipboard.

Copy Copies data to the clipboard.

Paste Inserts data from the clipboard.

Delete Deletes data.

View

View sample data Define view of identifications Id1...Id7 on the Sample data and

Silo tabs (see section 5.2.2).

View results Define view of results on the Silo tab (see section 5.3.4).

Audit Trail Opens Audit Trail table (see section 7.3.1).

Extra

Configuration Opens the TiNet 2.5 - Configuration window (see section 2.2).

Methods

New method Opens a new empty method in the TiNet 2.5 - Configuration

window (see section 4.2.1).

Edit method Opens the selected method in the TiNet 2.5 - Configuration

window (see section 4.2.2).

Method administration Opens the Method administration window (see section 4.3.1).

Use signed methods
only

Enable/Disable restricted use of signed database methods
(see section 4.3.7).

Method directory Select the directory of the methods for the method select

lists (see section 4.2.3).

Results

Results overview Opens the Results overview window for display of determina-

tion data stored in the result database (see section 6.3.1).

36 • Titrations TiNet 2.5 Compliant

TiNet database Opens the TiNet 2.5 - Results program window for display and

recalculation of determination data stored in the TiNet data­base (see section 6.2).

Security policies Settings for login, password protection, Audit Trail, and de-

fault strings (see section 3.1).

User administration Administration of user groups and users and their access

policies (see section 3.2).

Options

Curve settings Options for display of live curves (see section 3.4.1).

Print options Options for report printout (see section 3.4.2).

Export settings Options for export of results (see section 3.4.3).

System name Definition of the system name for Audit Trail (see section

3.4.4).

Database options Options for method, result and Audit Trail databases (see

section 3.4.5).

Commands

Start Starts the method (see section 5.4.3).

Stopp Stops the method (see section 5.4.3).

Continue Continue with the method after hold by

"Wait/Message/Request" block (see section 5.4.3).

Conditioning Starts conditioning (see section 5.4.3).

Clear statistics Clears the current value of the statistics counter.

Clear autostart Clears the current value of the auto start counter (see section

5.2.2).

Initialise devices Initializes the connected devices.

Help

Help contents Shows the contents of the Help texts.

About Shows the program version.

TiNet 2.5 Compliant Titrations • 37

5.2 Sample data

5.2.1 Sample data entry

Every parallel titration has its own Sample data # tab in the main window for
display and entry of sample data.

User Display of the logged-in user. The name will be printed out with

the titration data and stored in the determination.

Remark Enter the remark regarding, e.g. the sample series. It will be

printed out with the titration data and stored in the determina­tion.

State Display of TiNet state.

Autostart Number of automatic, internal starts. Select this option for se-

ries determinations with a sample changer. The number on the
left counts the starts already performed (current value counter),
the total number of starts which must be performed is on the
right (set counter). Enter the number of samples on the sample
changer in the right counter.

The current value counter can be zeroed with the menu item

Commands, Clear autostart. The counter is also set to 0 if you

answer yes to the question New series?.

Auto start is interrupted when the option is disabled.

Silo Open silo memory for sample data (see section 5.2.2). If the

Silo option is enabled, the sample data are transferred for each

determination from the silo and displayed under Sample data.
This option must be enabled in order to edit the silo memory.

38 • Titrations TiNet 2.5 Compliant

Sample data

Here, you can enter sample data for single determinations and
multiple determinations with autostart. These date will be
printed out with the titration data and stored in the determina­tion. If the Silo option is enabled, the fields can not be edited.
During the method sequence, the current data from the silo
memory are displayed in these fields.

Method

Selection of the method used to process the sample. The
method is reloaded on every start.

Version

Display of method version number.

Id1...7 Identifications of the sample (up to 30 characters each).

You can define in the

View sample data window (see section

5.2.2) the identifications which should be displayed. The identi-

fications can be used in the method sequence as variables
(e.g. for calculations or IF decisions).

Note:
Modifications of the identifications ID1...7 made after the start of
a determination are ignored for this determination.
used for saving the version number of the database method.

ID8 is always

Sample size

Sample size (mass).
The sample size is available for calculations in the method as a
variable.

Note:
If the

Sample size is modified and confirmed with <Enter> after

the start of a determination, the modified value will be used for
this determination.

Unit Unit of the sample size.

Application note

The application not of the current method loaded is displayed
in the green field (if present). The application note can be cre­ated in the program part "Methods" (see section 4.2.2). It can
be exported as a text file (

*.txt) and printed.

TiNet 2.5 Compliant Titrations • 39

5.2.2 View for sample data

TiNet 2.5 Compliant, View, View sample data

This menu item opens the View sample data window. You can define here
which identifications with which names will be displayed on the

data

and Silo tabs in the main window.

Sample

Id1...Id7

Identifications which can be displayed (display only) .

(Designation)

User-defined designations for identifications.

Visible Selection of the identifications to be displayed in the main win-

dow.

40 • Titrations TiNet 2.5 Compliant

5.3 Silo memory

5.3.1 Display silo memory

Every parallel titration has its own silo memory, which is shown on the Silo

#

tab in the main window. The silo memory is used on one side for the
display of the finished determinations and their results, and on the other
side for entering sample data "for future use" (e.g. for sample series with a
sample changer).

The silo memory contains the Status column and the columns defined un­der View sample data (see section 5.2.2) and View results (see section

5.3.4).

Status Display of the determination status:

ready The sample data are used for the next

determinations.

running The determination is running.
finished The determination is finished, results have

been entered.

aborted The determination has been aborted.

For automatic processing of sample data from the silo memory for series
determination, the Silo option on the Sample data tab must be enabled and
the number of automatic starts must be entered in the Autostart field. In
this case, the sample data are transferred from the silo memory at each
new method start. The weighing data from a connected balance are writ­ten to the silo memory. The silo memory operates on the FIFO (first in, first
out) principle: The lines are entered and processed in ascending order.

If the silo memory is enabled, the sample data can be edited using con­text-sensitive menu items (see section 5.3.2). The content of the silo mem­ory can be saved, loaded or deleted (see section 5.3.3).

TiNet 2.5 Compliant Titrations • 41

5.3.2 Edit silo memory

Edit silo row

(Silo memory), Edit silo row

To edit data of the silo memory, click into the silo memory using the right
mouse key and select the
is opened. If an empty silo row has been selected, the previously entered
data are shown in this window.

Edit silo row menu item. The Edit silo row window

Method Selection of the method to process the sample. The method is

reloaded at every new start.

Version Display of method version.

Id1...7 Identifications of the sample (up to 30 characters each).

You can define in the

View sample data window the identifica-

tions which should be displayed. In addition to this, identifica­tions can be renamed.
The identifications can be used in the method sequence as
Variables (e.g. for calculations or IF decisions).

Sample size

Sample size (mass).
The

sample size is available for calculations in the method as a

variable.

Unit Unit of the sample size..

<Apply> Use this button to transfer the sample data into the selected ex-

isting silo row or into a new empty silo row.

<Close> Use this button to close the Edit silo row window.

This context-sensitive menu item is only active if the Silo option is enabled
on the Sample data tab.

42 • Titrations TiNet 2.5 Compliant

Insert silo row

(Silo memory), Insert silo row

To insert a new silo row into the silo memory, select the desired row by
clicking it using the left mouse key. Then click into this row using the right
mouse key and select the Insert silo row menu item. The Edit silo row win­dow is opened for entering data for the new row. With

<Apply>, a new silo

row containing these data is created above the selected silo row.

This context-sensitive menu item is only active if the Silo option is enabled
on the

Sample data tab.

Delete silo row

(Silo memory), Delete silo row

To delete a single silo row in the silo memory, select the desired row by
clicking it using the left mouse key. Then click into this row using the right
mouse key and select the Delete silo row menu item.

This context-sensitive menu item is only active if the Silo option is enabled
on the Sample data tab.

Delete all silo rows

(Silo memory), Delete all silo rows

To delete all silo rows in the silo memory, click into the silo memory table
using the right mouse key and select the

Delete all silo rows menu item.

Enter new silo data

To enter data into a new, empty row of the silo memory, select the desired
empty row by clicking it using the left mouse key. Then click into this row
using the right mouse key and select the

silo row
ply>
silo row

every click on

window is opened for entering the desired sample data. With <Ap-

, these data are filled into the first empty silo row. Afterwards, the Edit

window remains open for the entry of additional silo rows. With

<Apply>, a new silo row is filled.

Edit silo row menu item. The Edit

Modify existing silo data

To modify data in an existing row of the silo memory, select the desired
row by clicking it using the left mouse key. Then click into this row using
the right mouse key and select the

row

window is opened for modifying the desired sample data. With <Ap-

ply>

, these modified data are filled into the selected silo row. Afterwards,

Edit silo row menu item. The Edit silo

the Edit silo row window shows the data of the next silo row.

TiNet 2.5 Compliant Titrations • 43

5.3.3 Load, save, and delete silo

Load silo

TiNet 2.5 Compliant, File, Load silo

This menu item opens the Open window for selection of the desired silo file

*.tso to be loaded into the silo memory.

Save silo

TiNet 2.5 Compliant, File, Save silo

This menu item opens the Save file as window for saving the current silo
memory with the desired file name.

Delete silo

TiNet 2.5 Compliant, File, Delete silo

This menu item opens the Delete silo file window for selection of the de­sired silo file to be deleted.

5.3.4 View results

TiNet 2.5 Compliant, View, View results

This menu item opens the View results window. You can define here which
results with which names will be displayed on the Silo tab in the main win­dow.

44 • Titrations TiNet 2.5 Compliant

RS1...10 Name

Result names which can be displayed (display only).

RS1...10 Value

Result values which can be displayed (display only).

RS1...10 Unit

Result units which can be displayed (display only).

Designation

User-defined designations for results.

Visible Selection of the results to be displayed in the silo.

TiNet 2.5 Compliant Titrations • 45

5.4 Performing titrations

5.4.1 Preparing single determinations

Before starting single determinations, proceed as follows:

• Connect, switch on and initialize devices (see section 2.1).

• Start TiNet 2.5 Compliant.

• Disable the

5.2.1).

• Enter method and sample data on the

5.2.1), or

• Enable the

sample data in the silo memory (see section 5.3.1)

Autostart option on the Sample data tab (see section

Silo option on the Sample data tab and enter method and

5.4.2 Preparing sample series

Before starting single determinations, proceed as follows:

• Connect and initialize devices (see section 2.1).

• Enable the

of samples (see section 5.2.1).

• Enter method and sample data on the

5.2.1), or

• Enable the

sample data in the silo memory (see section 5.3.1)

Autostart option on the Sample data and enter the number

Silo option on the Sample data tab and enter method and

Sample data tab (see section

Sample data tab (see section

5.4.3 Buttons for titrations

The individual buttons in the main window have the following meaning:

Starts the determination. The button is shown gray
when it is not active.

Stops the determination. The button is shown gray
when it is not active. Can also be used as an emer­gency stop. If a Titrino stops, TiNet must be
stopped manually.

Continues with the determination after hold by
"Wait/Message/Request" block. The button is shown
gray when it is not active.

Start conditioning. The button is shown gray when it
is not active.

46 • Titrations TiNet 2.5 Compliant

5.4.4 Working with connected balance

Weighing data of a connected balance can be transferred.

The receipt of weighing data is confirmed by the PC with a beep.

Important: Depending on the work load of your PC, you should wait a few
seconds between transmissions of the individual weighing data.

The balance is always assigned to the active parallel titration. If the
option is disabled, the weighing data are sent directly to the current sam­ple data row. If the Silo option is enabled, they are sent to the silo.

5.4.5 Karl Fischer titrations

Start/Stop

Start conditioning with button <Conditioning>.

Wait for a stable drift and start the titration. The titra­tion can only be started if "conditioning is ok". The
titration start stops the conditioning; it is therefore
important that there is not a great delay between the
start and the beginning of the titration. After the PC
method is terminated, the titration vessel is again
conditioned.

Silo

This key stops the titration as well as the condition­ing.

Prerequisites in the method

Conditioning has to be activated in the titration blocks of the method.
Conditioning is possible for the following blocks:

• KFC (conditioning is always active)

• KFT

• SET

• Titrino method (conditioning is active in the Titrino method)

TiNet 2.5 Compliant Titrations • 47

Notes

• Autostart starts only the titration. If you wish to condition, start condi­tioning (

<Conditioning>) first.

• If the method contains an IF, the parameters used for conditioning
are in the left (TRUE) branch.

• If the method contains several blocks with conditioning, the parame­ter of the first block are valid for conditioning.

Working with the 774 Oven Sample Processor

• After heating up the system, the first determination should always be
discarded. You should therefore prepare one "blank" vial more than
necessary.

• Start the series with key

<Start> in TiNet: If the option conditioning

for the Oven Sample Processor is active in the corresponding
method, the sample changer goes to the conditioning vial, switches
the gas flow on and waits until the temperature is reached. The titra­tor is conditioned at the same time.

• If the Oven and the titrator are conditioned, the titration series will be
started with autostart.

• The stirrer is controlled by TiNet if you work with the 756/831 KF Cou­lometer or 751, 758, 784, 785 Titrino. For other titrators, please
switch stirrer on manually.

• If you work off several series at different temperatures, we recom­mend to have an empty dummy method which sets the temperature
between the series. This method should change the temperature and
wait for its equilibration.

• If a method contains different temperatures for conditioning of the
Oven Sample Processor, only the first is valid.

• If a method contains an IF block, the parameters of the left branch
(TRUE) are used for conditioning.

48 • Titrations TiNet 2.5 Compliant

5.4.6 Live titration curves

For every connected titration device, a tab with the name of this device is
displayed in the main window. On these tabs, the live curves of running
determinations will be displayed. The view of this curves can be defined

TiNet 2.5 Compliant, Extra, Options, Curve settings (see section 3.4.1).

with

5.4.7 Emergency stop

<Stop> immediately stops the run. Any calculations and report instruc-

tions after this sop point will not be carried out.

If you wish to stop only one titration, one measurement or any single de­vice procedure, you can do this with the

<STOP> key on the device itself.

TiNet 2.5 Compliant Titrations • 49

5.5 Parallel titrations

5.5.1 Add parallel titration

File, Add parallel titration

Use this command if you wish to perform several titrations at the same
time.

A new tab for the added parallel titration is opened. For a better overview,
it is advisable to use the connected devices only in one parallel titration at
the same time, e.g. Titrino 1 and Sample Changer are used in parallel titra­tion 1; Titrino 2 in parallel titration 2.

The parallel titrations are independent of each other. The buttons

<Stop>, <Continue> are always effective for the visible parallel titration. All

other commands under the menu item
lel titration.

Each parallel titration has an own silo memory. The commands under
menu item

File apply to the active silo memory.

Note:

If you are working with parallel titrations, you should not use methods
generating PDF reports.

5.5.2 Remove parallel titration

File, Remove parallel titration

Use this command if you wish to remove the parallel titration added last.

The tab with the opened parallel titration is removed from the main win­dow.

<Start>,

Commands also apply to this paral-

5.5.3 Rename parallel titration

Use the context-sensitive command Rename to change the default name

Titration No. # on the tab. The Name window is displayed where the desired

name can be entered and confirmed with <OK>.

50 • Titrations TiNet 2.5 Compliant

6. Results

6.1 General information on determination data

TiNet 2.5 Compliant saves determination data in two different databases
which are called TiNet database and Result database.

TiNet database

In the TiNet database, determination data are stored non-compliant to 21
CFR Part 11. Data can be displayed, sorted, and recalculated (see section

6.2).

Result database

In the Result database, determination data (including raw data file and
method file) are stored in compliance to 21 CFR Part 11 and shown in the

Results overview table (see section 6.3). Results can be electronically

signed and PDF reports and result reports can be printed.

6.2 TiNet database

TiNet 2.5 Compliant, Extra, Results, TiNet database

This menu item opens the TiNet 2.5 – Results window. Here, data of the Ti­Net database can be displayed, sorted, and recalculated. You will find de­tailed information on the TiNet database in the 8.110.8243 Instructions
for Use "TiNet 2.4/2.5", section 8.

TiNet 2.5 Compliant Results • 51

6.3 Results overview

6.3.1 Display of results

TiNet 2.5 Compliant, Extra, Results, Results overview

This menu item opens the Results overview window for display of the de­termination data stored in the result database in a tabular form.

Each row of the results overview table contains data of a single determina­tion. The determinations are sorted chronologically in descending order,
e.g. the last determination performed is in the first row.

The columns of the results overview table are described in section 6.3.2.

Select determinations

A single determination can be selected by clicking into any field of the row
using the left mouse key. The selected row is marked with the

the first column.

The navigation keys below the table can be used to select another deter­mination:

Select first determination.

Select previous determination.

Select next determination.

Select last determination.

icon in

52 • Results TiNet 2.5 Compliant

Menu items

The

Results overview table contains the following menu items:

File

Show PDF report Show PDF report of the selected determina-

tion in the Adobe Acrobat Reader program
(see section 6.3.3).

Print result report Print result report of the selected determina-

tion (see section 6.3.4).

Sign result Electronically sign the results of the selected

determination (see section 6.3.5).

Export result Export the results of the selected determina-

tion (see section 6.3.6).

Delete result Delete the results of the selected determina-

tion (see section 6.3.7).

Close Close Results overview window.

View

Column view Define column view for the results overview

table (see section 6.3.8).

Edit filter Edit filter options for the Results overview table

(see section 6.3.9).

Apply filter Apply filter for the Results overview table (see

section 6.3.10).

TiNet 2.5 Compliant Results • 53

6.3.2 Columns of the results overview table

The following columns can be displayed in the results overview table (see
also section 6.3.6):

Record Automatically generated, consecutive number for data sets.

Date Date when determination was started.

Time Time when determination was started.

User Name of the user who has started the determination.

Remark Remark entered on the Sample data tab.

Method Name of the method used to process the determination.

Version Version number of the method used.

Id1...Id7 Sample identifications.

Sample size

Sample size (mass).

Unit Unit of the sample size.

RS1...15 Name

Name for result 1...15

RS1...15 Value

Value for result 1...15

RS1...15 Unit

Unit for result 1...15

Signer User name of the last user who signed the determination.

Signer name

Full name of the last user who signed the determination.

Sign date

Date and time when the determination was signed.

Sign comment

Comment entered at signing the determination.

54 • Results TiNet 2.5 Compliant

6.3.3 Show PDF report

Results overview, File, Show PDF report

This menu item opens the PDF report of the selected determination with
the Adobe Acrobat Reader, from which it can be printed to the desired
printer.

Note: PDF reports can only be displayed if they have been generated
automatically at the end of the determinations. This happens only if the
method contains a report block with the Print immediately option enabled,
and if the

Print options are set in order to create PDF reports (see sections

1.1.2 and 3.4.2).

TiNet 2.5 Compliant Results • 55

6.3.4 Print result report

Results overview, File, Print result report

With this menu item, a result report of the selected determination is printed
on the default printer.

56 • Results TiNet 2.5 Compliant

This report contains the following entries (independent of the set column
view):

Date: Date when determination was started.

Time: Time when determination was started.

User: Name of the user who has started the determination.

Remark: Remark entered on the Sample data tab.

Method: Method name.

Version: Version number of the method

Id1...Id7 Sample identifications (all identifications which are not empty

are printed).

Sample size

Sample size (mass).

Unit Unit of the sample size.

Results Results (all results which are not empty are displayed)

Report printed on:

Date and time when the result report was printed.

Signed by:

Full name of the user who signed the results.

Signed on:

Date and time when the results were signed.

Sign comment:

Comment for the signature.

6.3.5 Sign result

Results overview, File, Sign result

With this menu item, the Sign-off window appears for applying electronic
signatures on results of the selected determination (the old signature data
is overwritten).

TiNet 2.5 Compliant Results • 57

User name

Name of the user who wants to sign the results.

Password

Password of the user who wants to sign the results.

Meaning User-specific comment to the signature.

6.3.6 Export result

Results overview, File, Export result

With this menu item, the results of the selected determination are exported
according to the set

Export settings (see section 3.4.3).

Import of results into the results database is impossible.

6.3.7 Delete result

Results overview, File, Delete result

With this menu item, the results of the selected determination can be de­leted.

After confirmation of the deleting action, the Delete result window opens,
where two administrators must confirm the deletion by entering user name
and password.

58 • Results TiNet 2.5 Compliant

6.3.8 Column view for results overview

Results overview, View, Column view

This menu item opens the Column view window for definition of the col­umns (display, name, width) to be displayed in the results overview.

Column Name of the parameter to be displayed as column (display

only, meaning see section 6.3.2).

Designation

User-specific designations for columns.

Width Column width in pixel. The column width can also be set in the

results overview table by drag and drop of the column border
using the left mouse key.

Visible Selection of columns to be displayed in the results overview ta-

ble.

TiNet 2.5 Compliant Results • 59

6.3.9 Edit filter for results

Results overview, View, Edit filter

This menu item opens the Edit filter window for definition of filter conditions
to filter the results overview table.

Field name

Selection of the desired column for the filter condition.

Operator Selection of the operator for the filter condition (=, <>, <, >).

Value Value for the filter condition.

The two filter conditions can be combined either with And or with Or.

The filter is applied to the results overview table with

Apply filter

.

6.3.10 Apply filter for results

Results overview, View, Apply filter

Apply the filter set with Results overview, View, Edit filter to the results over­view table.

Results overview, View,

60 • Results TiNet 2.5 Compliant

7. Working according to 21 CFR 11

In this section, you will find a detailed description how to work with "TiNet

2.5 Compliant" according to 21 CFR 11. In order to do this, the program
must have been installed according to section 1.2.2.

7.1 Program settings

7.1.1 First login

1. Open the TiNet 2.5 Compliant program. The Login window appears.

2. Enter "

for

Admin" for User name and "TiNet2" (pay attention to capitalization)

Password. Click on <OK>.

7.1.2 Security policies

1. Select Extra/Security policies to open the Security policies window (see

section 3.1).

2. On the Login/Password protection tab, click on <Apply> to set the pa-

rameters according to 21 CFR 11 (see section 3.1.1). If desired, mod­ify the maximum number of login attempts, the automatic logoff time,
the minimum password length and the password expiration time.

3. On the

ing to 21 CFR 11 (see section 3.1.2).

4. On the

strings for comments on method modifications and signatures.

Audit Trail tab, click on <Apply> to set the parameters accord-

Default strings tab, add, modify and delete the desired default

5. Click on <OK> to close the Security policies window.

TiNet 2.5 Compliant Working according to 21 CFR 11 • 61

7.1.3 Addition of new administrators

1. Select Extra/User administration to open the User administration window

(see section 3.2).

2. Using the right mouse key, click on the selected Administrator group
and select the

New user menu item.

3. Enter
click on

User name, Full name and Remarks for the new administrator and

<Accept>.

4. Repeat this procedure (steps 2 and 3) to enter a second new user
with administrator policies.

5. If desired, repeat this procedure (steps 2 and 3) to enter more users
with administrator policies.

6. Click on <OK> to close the User administration window.

7. Click on

<Logout>. The Login window opens (see section 3.3.1).

8. Enter the user name of one of the new administrator users into the

User name field and the same user name into the Password field. Click

on

<OK>.

9. Confirm the message appearing in the Information window with <OK>.
The Change password window appears.

10. Enter the user name into the Old password field and a new password
into the New password field. Confirm this password by reentering it in
the

Confirm password field and click on <OK>.

11. Enter the new password in the Login window and click on <OK>.

12. Select Extra/User administration to open the User administration window.

13. Expand the

Administrator branch in the left field of the window and se-

lect the Admin user.

14. Using the right mouse key, click on the selected
the

Remove user menu item.

Admin user and select

15. Confirm the appearing message with <OK>. The Admin user will be
removed from the Administrator group.

62 • Working according to 21 CFR 11 TiNet 2.5 Compliant

7.1.4 Addition of user groups and users

1. Using the right mouse key, click into the left field of the User administra-

tion

window (see section 3.2) and select the New group menu item.

2. Enter the desired

Group name and Description and click on <Accept>

(see section 3.2.1).

3. Expand the new user group branch and click on

Access policies (see

section 3.2.2).

4. Disable the desired menu items, which should not be accessed by
this user group, and click on

5. Click on

Signatures (see section 3.2.3).

<Accept>.

6. Enable or disable the electronic signature policy for methods and re­sults for this group and click on

<Accept>.

7. Using the right mouse key, click on the new user branch and select
the

New user menu item.

8. Enter

User name, Full name and Remarks for the new user and click on

<Accept>.

9. Repeat this procedure to enter all the desired user groups and users.

10. Click on <OK> to close the User administration window

7.1.5 Print options

1. Select Extra/Options/Print options to open the Print options window (see
section 3.4.2).

2. In the

Print options for TiNet reports box, enable the Special printer op-

tion and select the FinePrint pdfFactory Pro printer driver.

3. In the

Print options for PDF reports box, select the printer to which PDF

reports will be printed.

4. Select the directory to which PDF reports will be saved.

5. Enable or disable the option for immediate printing of PDF reports
(Adobe Acrobat Reader must be installed).

6. Click on <OK> to close the Print options window.

TiNet 2.5 Compliant Working according to 21 CFR 11 • 63

7.2 Configuration of devices

1. Select Extra/Configuration to open the TiNet 2.5 Configuration window.

2. Configure all devices connected to the PC (see 8.110.8243 Instruc-

tions for Use "TiNet 2.4/2.5", section 2).

3. Close the

TiNet 2.5 Configuration window.

7.3 Methods

7.3.1 Create new draft methods

1. Select Extra/Methods/New method to open the TiNet 2.5 Methods win-
dow.

2. Create the new draft method (see 8.110.8243 Instructions "TiNet

2.4/2.5", section 2).

3. In order to generate automatically a PDF report, make sure that the

Print immediately option is enabled in the report block. This report gen-

eration only works with one report block per method (others are ig­nored).

4. Save the new method in the desired directory.

5. Close the TiNet 2.5 Methods window.

7.3.2 Save methods in the method database

1. Select Extra/Methods/Method administration to open the Method admini-

stration

2. Select the Current method directory from which you would copy draft
methods into the method database.

3. Select the desired draft method, which should be saved as database
method.

4. Using the right mouse key, select the
item. The

window (see section 4.3.1).

Save method in database menu

Comment on method modification window appears.

64 • Working according to 21 CFR 11 TiNet 2.5 Compliant

5. Select a method description and enter a comment for the method.
Click on

<OK>.

6. You are asked if you want to sign the method. Click on <Yes> (details
see section 7.3.3) or <No>.

7. Repeat this procedure for all draft methods you want to save in the
method database.

8. Close the Method administration window.

7.3.3 Sign methods

1. Select Extra/Methods/Method administration to open the Method admini-

stration

2. Select the desired database method, which should be signed.

window (see section 4.3.1).

3. Using the right mouse key, select the

Sign-off window appears.

Sign method menu item. The

4. Enter your user name and password and select or enter a sign com­ment. Click on <Sign-off> to sign the method. Afterwards, click on

<Sign-off>.

TiNet 2.5 Compliant Working according to 21 CFR 11 • 65

5. If desired, print a method report including all method data stored in
the method database by selecting the
the right mouse key.

6. Close the Method administration window.

7.3.4 Restrict method selection

1. Enable the Extra/Methods/Use signed methods only option to make sure
that only signed database methods can be selected in the
field of the

Sample data tab and for the silo.

Method report menu item using

Method

2. To make sure that users cannot disable the
option, disable this menu item for the user group under

stration/'Group'/Access policies/Menu items

7.4 Results

7.4.1 Sign results

1. Select Extra/Results/Results overview to open the Results overview win-
dow (see section 6.3).

2. Select the desired result, which should be signed.

3. Using the right mouse key, select the

Sign-off window appears.

Use signed methods only

User admini-

(see section 3.2.2).

Sign-off result menu item. The

4. Enter your user name and password and select or enter a sign com­ment. Click on <Sign-off> to sign the result. Afterwards, click on

<Sign-off>.

5. If desired, print a result report including all determination data stored
in the result database by selecting the Result report menu item using
the right mouse key.

6. Close the Results overview window.

66 • Working according to 21 CFR 11 TiNet 2.5 Compliant

7.4.2 Show and print result reports

1. Select Extra/Results/Results overview to open the Results overview win-

dow (see section 6.3).

2. Select the desired result whose PDF report should be shown. Using
the right mouse key, select the
Acrobat Reader program opens showing the PDF report of the se­lected determination. This report can be printed or copied to the de­sired directory.

3. Select the desired result whose result report should be printed. Using
the right mouse key, select the Print result report menu item. The result
report including all relevant data of the determination (including
method name, method version and signature data) is printed on the
selected printer. Using the Adobe Acrobat program (full version), it is
possible to generate a PDF file of this report and save it in the desired
directory.

Show PDF report menu item. The Adobe

TiNet 2.5 Compliant Working according to 21 CFR 11 • 67

7.5 Audit Trail

7.5.1 Display Audit Trail

TiNet 2.5 Compliant, View, Audit Trail

This menu item opens the

Audit Trail window where all program actions

defined as Audit Trail actions are displayed. The Audit Trail table contains
the following columns:

Type Icon for characterization of the Audit Trail action:

Information for correct action.

Warning for special action.

Error or malfunction.

Date Date and time of the Audit Trail action.

Time zone

Time zone of the Audit Trail action.

Source Display of the source program part of the Audit Trail action.

User Short name of the logged-in user.

User name

Full name of the logged-in user.

Action Details of the Audit Trail action.

System name

System name defined with Extra, Options, System name.

68 • Working according to 21 CFR 11 TiNet 2.5 Compliant

Exported Display, if the Audit Trail action has already been exported or

not.

The

Audit Trail window contains the following menu items:

Audit Trail, File, Find date…

In the

Date window, the desired date can be selected.

Audit Trail, File, Export

Export Audit Trail actions.

Audit Trail, File, Delete

Delete Audit Trail actions.

Audit Trail, View, Column view

Define the column view of the Audit Trail table.

7.5.2 Export Audit Trail

Audit Trail, File, Export

This menu item opens the Export Audit Trail window for selection of the
range for export of Audit Trail actions. Afterwards, file name and directory
for saving the export file (

*.txt) must be entered.

TiNet 2.5 Compliant Working according to 21 CFR 11 • 69

7.5.3 Delete Audit Trail

Audit Trail, File, Delete

With this menu item, the Delete Audit Trail window opens, where two ad­ministrators must confirm the deletion by entering user name and pass­word. Afterwards, the Export Audit Trail window for selection of the range
for export of the Audit Trail actions, which are exported prior to the dele­tion.

7.5.4 Column view for Audit Trail

Audit Trail, View, Column view

70 • Working according to 21 CFR 11 TiNet 2.5 Compliant

This menu item opens the Column view window for definition of the col­umns (display, name, width) to be displayed in the Audit Trail table. The
following columns can be edited:

Column Name of the parameter to be displayed as column (display

only).

Designation

User-specific designations for columns.

Width Column width in pixel. The column width can also be set in the

Audit Trail table by drag and drop of the column border using
the left mouse key.

Visible Selection of columns to be displayed in the Audit Trail table.

TiNet 2.5 Compliant Working according to 21 CFR 11 • 71

72 • Appendix TiNet 2.5 Compliant

8. Appendix

8.1 Software license

The use of the Software is subject to this License Agreement between you
and Metrohm AG. With the offer, you have received this License Agree­ment and taken note of it. You have already accepted this License Agree­ment upon the placement of your order with Metrohm AG or one of its dis­tributors or upon confirmation of the order by Metrohm or one of its dis­tributors. At the very latest, you agree to be bound by the terms of this Li­cense Agreement when you start using the Software.

1. Metrohm grants you the non-transferable and non-exclusive right to
use this Software in connection with Metrohm analysis devices.

2. The copyright to the Software is retained by Metrohm or a licensor of
Metrohm. You are not permitted to alter or remove any notes regard­ing confidential handling, indications of title or indications of copyright.
You are not permitted to sell the Software, lease it to or otherwise pass
it on to third parties, except in conjunction with its use with analysis
devices of the Metrohm Group and if the third party expressly agrees
to the terms of this License Agreement. It is not permitted to change
or copy the Software in its entirety or in part. It is only permissible to
make one copy for backup purposes.

3. The license fee for the above use is included in the sales price of the
analysis device. If the software is supplied separately, the fee is billed
along with the Software. If for any reason the sales price or the license
fee is not paid in full by the due date, the right to use the Software
lapses and Metrohm is entitled to demand the return of the Software
or its deletion from your system.

4. Metrohm warrants that the Software is suitable for the indicated use
with analysis devices of the Metrohm Group if properly operated and
that the Software is properly stored on the data carrier. If this is not the
case, you are entitled to demand that Metrohm and/or its distributor
provide you with a new flawless Software in exchange for handing in
the Software you have complained about. This warranty applies to ini­tial operators of the Software only.

5. Metrohm and its distributor disclaim all other warranties and liability. In
particular, Metrohm and its distributor assume no liability for third­party damage or consequential damage, loss of data, lost profits, in­terruption of business, etc.

6. This Agreement applies until it is terminated. You can terminate this
Agreement by destroying the Software and every copy of it. The
Agreement is also deemed terminated if you violate any of its terms, in
which case you are also obligated to destroy the Software and every

TiNet 2.5 Compliant Appendix • 73

copy of it, whereby Metrohm is also entitled to explicitly demand this
of you.

7. Any changes and amendments to this Agreement must be rendered
in writing to attain validity. This stipulation requiring written form also
applies to a change in this provision. If parts of this Agreement prove
to be null and void or legally ineffective now or in the future, the re­mainder of the Agreement continues to apply. The Agreement must
then be interpreted and applied so that the intended purpose of the
ineffective section is nevertheless achieved to the greatest extent pos­sible.

8. Venue: Any disputes arising from this Agreement shall be decided by
the courts at the location of the registered office of Metrohm AG.
Metrohm is also entitled to demand that the venue be the location of
the defendant's registered office.

8.2 Declaration of conformity – Software validation

The software "Metrodata TiNet 2.5 Compliant" was developed in accor­dance with the requirements of the ISO 9001 quality system regarding the
design, testing and servicing of Metrodata software. The relevant proce­dures are described in the document "Project procedure for creating Met­rodata software" which is available at your Metrohm agency on request.

The software was validated with respect to functionality, analytical per­formance and accuracy of results. The technical specifications and soft­ware functions are described in the Instructions for Use.

Herisau, July 1, 2003

Dr. J. Frank Ch. Buchmann
Vice President Vice President
Head of R&D Head of Production

Responsible for Quality Assurance

74 • Appendix TiNet 2.5 Compliant

8.3 Accessories

8.3.1 Standard equipment

TiNet 2.5 for n devices ...................................................... 6.6012.140

including

Dongle ........................................................................................6.2145.000

TiNet 2.5 for 2 devices ...................................................... 6.6012.540

including

Dongle ........................................................................................6.2145.060

Both versions are supplied with the following documents:

Registration card ........................................................................8.110.8167

Compliance White Paper for TiNet 2.5 Compliant (English) ...... 8.110.8343

Instructions for Use TiNet 2.4/2.5 (German)...............................8.110.8241

Instructions for Use TiNet 2.4/2.5 (English)................................8.110.8243

Instructions for Use TiNet 2.5 Compliant (German)...................8.110.8351

Instructions for Use TiNet 2.5 Compliant (English) ....................8.110.8353

8.3.2 Options

Cables and adapters

Cable Metrohm device - PC:

Metrohm device 25-pin – PC 25-pin .................................... 6.2125.060

Metrohm device 9-pin – PC 25-pin ...................................... 6.2125.110

Metrohm device 25-pin – PC 9-pin ...................................... 6.2125.110

Metrohm device 9-pin – PC 9-pin ........................................ 6.2134.040

Adapter for 25-pin ⇒ 9-pin plug................................................. 6.2125.010

Cable PC-Balance

Sartorius-PC, 25-pin............................................................. 6.2125.070

Sartorius-PC, 9-pin............................................................... 6.2134.060

Mettler AM, PM, AT - PC, 25-pin .......................................... 6.2146.020

Mettler AM, PM, AT - PC, 9-pin .......................6.2146.020+6.2125.010

Mettler AE (Opt.011) - PC, 25-pin ........................................ 6.2125.020

Mettler AE (Opt.011) - PC, 9-pin .....................6.2125.020+6.2125.010

Mettler PG - PC, 25-pin ........................................................6.2125.130

Mettler PG - PC, 9-pin ..........................................................6.2134.110

Mettler AB, AG, PR - PC, 25-pin .................. Mettler Interface LC-RS25

Mettler AB, AG, PR - PC, 9-pin ...................... Mettler Interface LC-RS9

AND - PC, 25-pin .................................................................6.2125.020

AND - PC, 9-pin ..............................................6.2125.020+6.2125.010

Precisa - PC, 25-pin ............................................................. 6.2125.080

Precisa - PC, 25-pin ........................................6.2125.080+6.2125.010

Cable PC (25-pin)-Dosimat ........................................................6.2124.050

Adapter for the connection of one

electrode to 2 Titrinos.......... 6.2103.100

Interfaces for PC

USB Port Server (4 serial interfaces, 9-pin)................................ 2.145.0320

Multiport DIGI PCI (8 serial interfaces, 25-pin) ...........................2.145.0230

TiNet 2.5 Compliant Appendix • 75

9. Index

21 CFR 11 ................................13, 15, 61

Access policies ....................................17

Accessories..........................................75

Adapters...............................................75

Administrator policies...........................17

Appendix ..............................................73

Application note .............................32, 39

Apply filter.............................................60

Audit Trail

Column view......................................70

Delete ................................................70

Export................................................69

Settings .............................................15

Show .................................................68

Autostart ...............................................38

Backup ...................................................7

Balance ................................................47

Buttons for titrations .............................46

Cables ..................................................75

Change password................................20

Conditioning...................................46, 47

Configuration........................................11

Conformity............................................74

Connection of devices .........................11

Continue...............................................46

Create new method..............................28

Curve settings ......................................21

Database methods

Delete ................................................33

Display ..............................................29

Export................................................32

General information ..........................27

Report ...............................................33

Save ..................................................31

Use....................................................34

Database options................................. 25

Datenbankoptionen .............................24

Declaration of conformity.....................74

Default strings ................................15, 31

Deinstallation........................................10

Delete

Audit Trail actions..............................70

Methods ............................................33

Results ..............................................58

Determinations

Delete ............................................... 58

Display.............................................. 52

Export ............................................... 58

Export settings.................................. 23

General information.......................... 51

Result report ..................................... 56

Select................................................ 52

Sign................................................... 57

Dongle ........................................... 10, 75

Draft methods

Create ............................................... 28

Directory ........................................... 28

Display.............................................. 29

Edit.................................................... 28

General information.......................... 27

Drying titration vessel .......................... 47

Edit filter ............................................... 60

Electronic signature

Authorization..................................... 18

Comment.................................... 32, 58

Method ............................................. 32

Result................................................ 57

Emergency stop ............................ 46, 49

Entries for titrations........................ 38, 42

Export

Audit Trail.......................................... 69

Determinations ................................. 24

Methods............................................ 32

Results.............................................. 58

Settings............................................. 23

Filter ..................................................... 60

General information

Determination data........................... 51

Methods............................................ 27

Result database................................ 51

Results.............................................. 51

TiNet database ................................. 51

Working with TiNet.............................. 7

Help ....................................................... 7

Identifications............... 39, 40, 42, 54, 57

Installation

PDF Printer driver ............................... 8

TiNet 2.5 Compliant............................ 8

76 • Index TiNet 2.5 Compliant

Interfaces ............................................. 75

KF titrations.......................................... 47

License ................................................ 73

Live titration curves........................ 21, 49

Login

First login.......................................... 61

Login window ................................... 20

Options............................................. 13

Logout ................................................. 20

Main window.................................... 6, 35

Menu items.......................................... 36

Method directory ................................. 28

Methods

Administration .................................. 29

Create new method.......................... 28

Database methods........................... 27

Delete ............................................... 33

Directory ..................................... 28, 29

Draft methods................................... 27

Edit ................................................... 28

Export ............................................... 32

General information.......................... 27

Modification comment ..................... 30

Report............................................... 33

Save in database.............................. 31

Select method ............................ 39, 42

Settings according to 21 CFR 11..... 64

Sign .................................................. 32

Version.................................. 27, 30, 31

Modification comment......................... 30

Operating system .................................. 8

Ordering designations......................... 75

Oven Sample Processor ..................... 48

Overview ................................................ 5

Overview of TiNet .................................. 6

Parallel titrations .................................. 50

Password options................................ 14

Password protection ..................... 13, 20

PDF Factory Pro .................................... 8

PDF report

Print .................................................. 55

Print options ..................................... 22

Show................................................. 55

Performing titrations ............................ 46

Pre-titration .......................................... 47

Print

Options....................................... 22, 63

PDF report ........................................ 55

Printer selection................................ 22

Result report................................56, 57

Program description ..............................5

Program installation ............................... 8

Program parts ........................................ 6

Program settings.................................. 13

Program settings for 21 CFR 11 .......... 61

Program sub-directories ........................ 6

Purpose of program............................... 5

Remark................................................. 38

Rename parallel titration ...................... 50

Report

Database methods ...........................33

PDF report.........................................55

Print options...................................... 22

Result database

Database options .............................25

Delete results .................................... 58

Directory selection ............................25

Export results .................................... 58

General information ..........................51

Pack ..................................................25

PDF report.........................................55

Result report......................................56

Sign results ....................................... 57

Result report......................................... 56

Resultatdatenbank

Datenbankoptionen ..........................24

Results

Delete................................................ 58

Display ..............................................52

Export................................................ 58

General information ..........................51

Overview ...........................................52

Result database................................ 51

Result report......................................56

Settings according to 21 CFR 11 .....66

Sign ...................................................57

View................................................... 44

Results overview

Apply filter ......................................... 60

Column view .....................................59

Columns............................................ 54

Edit filter ............................................60

Menu items .......................................53

Open .................................................52

Sample data

Data transfer from balance ...............47

Entries ............................................... 38

Entry ..................................................42

TiNet 2. 5 Compliant Index • 77

View...................................................40

Sample identifications..39, 40, 42, 54, 57

Sample series ................................41, 46

Sample size..................39, 42, 47, 54, 57

Security policies .............................13, 61

Series ...................................................41

Signature

Authorization .....................................18

Comment ....................................32, 58

Method..............................................32

Result ................................................57

Silo

Delete all silo rows ............................43

Delete silo .........................................44

Delete silo row...................................43

Display ..............................................41

Edit silo row.......................................42

Enter new silo data ...........................43

Insert silo row ....................................43

Load silo............................................44

Modify existing silo data ...................43

Save silo............................................44

Set active...........................................38

Silo memory ......................................41

View results .......................................44

View sample data..............................40

Simultaneous titrations.........................50

Single determinations ..........................46

Size.......................................................39

Software

license............................................... 73

Software validation .............................. 74

Special character................................. 14

Special settings ................................... 11

Standard equipment............................ 75

Start...................................................... 46

State..................................................... 38

Status................................................... 41

Stop ............................................... 46, 49

System requirements............................. 8

TiNet database

General information.......................... 51

Open................................................. 51

TiNet report

Print options...................................... 22

Titration curves .............................. 21, 49

Titration stop ........................................ 49

Titrations .............................................. 35

User ......................................... 19, 38, 63

User administration.............................. 16

User groups............................. 16, 19, 63

User name ......................... 13, 19, 20, 38

View results.......................................... 44

View sample data ................................ 40

Weighing data...................................... 47

Working according to 21 CFR 11 ........ 61

Working with TiNet................................. 7

78 • Index TiNet 2. 5 Compliant