EV SOFTWARE
INSTALLATION AND TRAINING
QUICK REFERENCE GUIDE
Contents
1.0 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
1.1 Explanation of Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
2.0 Installing the Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
2.1 EV Standard Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
2.2 EV Pro Software .....................................................3
2.2.1 Daily Password ..............................................3
2.2.2 Installing EV PRO software .....................................6
2.2.3 Adding First Administrator (Super User) ...........................6
2.2.4 Creating/Editing/Changing Users/New Users/Administrators ...........7
3.0 Getting Started/Using the EV software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
3.1 EV Icons ...........................................................8
3.2 Introducing a logger for the rst time .....................................9
4.0 Writing tasks for EV loggers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
4.1 Quick Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
4.2 Completing the task form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
4.2.1 General Setup ..............................................11
5.0 Programming tasks to Loggers .............................................11
5.1 After a task has been programmed ......................................11
6.0 Logging Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
6.1 Manual Start/Stop Modes EV and EVt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
6.1.1 Delayed Start (EVt Only) ......................................12
6.2 Automatic Start/Stop Modes EV and EVt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
7.0 Retrieving Data from EV loggers ............................................12
7.1 Important Note regards EV Pro and 21 CFR Part 11 . . . . . . . . . . . . . . . . . . . . . . . .13
8.0 Graphing Data/Calculations ................................................13
9.0 Printing .................................................................13
10.0 Exploring the Database. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
10.1 Database Description ...............................................13
10.2 Editing Tasks/Sessions ..............................................14
10.3 Task Useful Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
10.4 Filtering/Sorting Tasks/Sessions .......................................15
10.5 Filter Recall .......................................................17
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2
11.0 Mean Kinetic Temperature/Lethality/Pasteurisation
(EV Pro Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
12.0 21 Title CFR Part 11 ......................................................18
12.1 What is 21 CFR Part 11? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
12.2 Title 21 CFR Denitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
12.3 Electronic Signatures (EV Pro Only) ....................................19
12.4 Audit Trails (EV Pro Only) ............................................20
12.5 21 CFR Part 11 Policy Statement ......................................21
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1.0 Introduction
This guide is intended as a quick start guide for the EV software. It covers the basics
of programming and data retrieval. Please refer to the main manual, which is included
electronically with the software as a PDF le in "Help-User Guide", for more comprehensive
instructions.
1.1 Explanation of Terms
Throughout this manual the following terms are used for clarity:
User = anyone who uses the software for programming and retrieving data from the EV
range of loggers
Administrator = the user who has been designated to authorise other users or
administrators.
Super User = An administrator whose password does not expire.
ICONS = Primary EV software functions.
Tasks = A series of instructions for a logger in order for that logger to perform a logging
duty.
Dock = The term used in the software to refer to the interface or cradle for the logger.
Session = A time period of data downloaded from a logger.
2.0 Installing the Software
2.1 For EV Standard software, follow these instructions:
Place the CD into the CD Drive on the PC and allow the software to install automatically.
Once installed Select: Start > Programs > EV Standard > EV to run the software.
Refer to section 3.0 of this guide ‘Getting Started/Using the EV software’.
2.2 For EV Pro Software, follow these instructions:
2.2.1 Daily Password
The EV Pro version of the software is password protected. In order to install
the software for the rst time the user must obtain a daily password from the
Comark Support website. The following information will be needed:
• User name and company details including user's e-mail address and a
password chosen by the user.
• The serial number from the CD itself. This is a 5 digit number prexed
with the letters WO with a forward slash followed by another number
of 1 or 2 digits, e.g. WO12345/67.
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Note : Please ensure when entering the serial number that the letters ‘WO’ are
added in front of the serial number if these are not shown on the CD.
Now visit the Comark website: www.comarksupport.com
The following image will appear:
Select Register and type the required information into the following screen:
Check the information entered and then select ‘Submit’ to conrm registration.
Note: Please be careful when entering the user's e-mail address as this will
become the user ID.
After registration, the user will need to login. To do so:
Select login from the menu and enter the user name and password into the boxes
provided.
After entering the user ID and password the software can be registered and the daily
password will be supplied.
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Select Register EV Pro software from the menu options.
Enter the number of copies of the software to be registered and select GO.
Enter today's date to obtain the daily password. The full serial number
e.g. WO12345/67 must be entered. Check the information entered and then select
submit.
Note : Please ensure that you add ‘WO’ in front of the serial number if these
are not shown on the CD.
The website will then supply the password for the current day, e.g. EV12345.
Important : Write this password down and then log out of the website.
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2.2.2 Installing EV PRO software
Insert the CDROM into the PC disc drive and let the software self-install.
When the software has installed select:
Start > Programs > EV Professional > EV Pro
to run the software.
At this point a password must be entered.
Enter the EV daily password obtained from the Internet and select OK.
2.2.3 Adding First Administrator (Super User)
At this stage of EV Pro software installation it is necessary to add the First
Administrator, who must be a "Super User", to the system
In order to add the First Administrator click on the ‘New User’ Icon -
see below.
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The user name must be entered into the name box. Note: The system will not
allow two users with the same name. Also, the user name cannot be changed
after it has been used to create a task.
The First Administrator must be a Super User. It is recommended that when
entering passwords for all users they are at least 8 characters long and
contain alphanumeric characters.
Press OK to nish.
The new First Administrator will be required to log on to the software by
entering his/her new password in the box shown.
The user will now be logged on to the software as a new administrator.
2.2.4 Creating/Editing/Changing Users/New Users/Administrators
Adding more new Users or Administrators is very simple. The First
Administrator must select Edit > Edit Systems > Users and re-enter his/her
password and click on OK.
The System Users setup screen will be displayed:
To set up a new user/administrator click on the ‘New User’ Icon.
Enter the name required and select the individual features from the list that the
new user will be allowed to access.
The new user can now use the software.
Please refer to the Quick Reference Guide section 3.0 Getting Started/Using
the EV software.
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3.0 Getting Started/Using the EV software
Basic system information is displayed at the top of the screen after the software is opened (EV
Pro users need to login rst).
3.1 EV Icons
A number of Icons are displayed across the top of the screen and these are used to
navigate through the software.
The Task database Icon will take the user to the task database view. This is a listing of all
programs that have been written for EV loggers.
The Filter task Icon takes the user to the lter options menu for task and session data.
The Graph Icon takes the user to the graph and data listing view.
The Multi-Graph Icon takes the user to the multi-graph selection screen.
Quick Program Icon. For more information on Quick program refer to section 4.0 Writing
Tasks.
Automatic ‘Dock’ Icon.
Split Screen Icon. Selecting this will change the screen view to split screen to show the
task database, graph and list data where applicable.
Clear Screen Icon. Selecting this will clear the screen of all task and data.
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3.2 Introducing a logger for the rst time
Select a logger and press the navigation button on the front. Diligence EV loggers
must be placed face down in the interface. EVt loggers should be placed face up. For
N3000 Graphic Display Monitors, simply connect the comms lead to the connector on
the side of the instrument. The EV software will now interrogate the logger or monitor
automatically.
The EV software will display an information message as follows:
This is normal because the logger is not known to the software. Select OK to continue.
This message will be repeated whenever a new logger is introduced to the software.
This applies to new loggers not known to the software and to loggers known to the
system but with no active tasks.
Note the change in state of the Quick Program Icon and the Docked Icon. Both will now
be active.
If no further action is taken then the following information message will be displayed after
a 1 minute:*
*Note: This message will be displayed repeatedly if the logger is left on the interface.
In these circumstances the time shown will be updated.
To prevent the battery from being drained, click OK and remove the logger from the
interface. The Quick program and Dock Icons will return to their inactive states.
Note: Clicking OK and leaving the logger on the interface will resume battery
consumption.
For more information on this please refer to the user guide within the software
section 3.2 Software Setup Options.
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4.0 Writing tasks for EV loggers
Tasks must rst be written and then programmed into the logger before it can be used.
The Task will dene the instructions for the logger to perform, i.e. to log data.
4.1 Quick Program
First make sure that you have an active logger in the dock/cradle. Press the quick
program Icon and the software will display a new task applicable to the logger in the
dock. See above.
The task can be programmed into the Logger using the ‘Program’ button. It will also be
automatically saved to the task database.
If the logger has timed out and is no longer active then the task will be simply saved to
the database.
4.2 Completing the task form
The task form has four areas, General Setup, Logging Mode, Log Interval and
Miscellaneous. At the top of the screen is the area for a task description plus the settings
for the channels on the logger. In the example above, an N2003/N2013 is in the dock.
4.2.1 General Setup
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In General Setup, denoted by the display box with scroll bar at the top of the screen (see
Section 4.0), there are several options to modify:
• Turn channels ON/OFF
• Set Low Alarm
• Set High Alarm
• Set scales for each channel
• Set scales for graph display (This setting can be changed even after data has
been downloaded)
• Set Alarm Delay
• Set Units for Alarm Delay
Scrolling to the right will reveal that it is also possible to set the Graph Max and Min
settings for the Y-Axis of Temperature and RH. (These can be changed after download)
The Colours used for the lines on the graph can also be set at this time. (These can be
changed after download). The line width for the graph can also be changed. (These can
be adjusted after download)
For more detailed information on other sections of the task please refer to the main user
guide within the software section 4.0 Writing Tasks for EV Loggers.
5.0 Programming tasks to Loggers
When the task is nished, select ‘Program’ to send the task to the logger and to save it to the
task database. The logger is now ready for use.
5.1 After a task has been programmed
After a task has been programmed to a logger there are two possible outcomes.
1. The logger is set for manual start
2. The logger is set for an automatic start, with delay (EVt only if progammed) or
without delay (EV and EVG).
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6.0 Logging Modes
6.1 Manual Start/Stop Modes EV and EVt
When a logger has been set for manual start then the logger display (if tted) will show
the word MAN in the lower portion of the LCD. In this case the user must press and hold
the navigation button on the front of the logger for 6 seconds to start logging. If manual
stop is also selected then the logger will require the same key operation in order to stop
logging.
6.1.1 Delayed Start (EVt Only)
If a delayed start has been programmed then the logger will display ‘dLAY’ to
indicate that it is counting down to the start time once the navigation button
has been pressed to initiate the programmed task.
6.2 Automatic Start/Stop Modes EV and EVt
In the event that either the start and stop are pre-programmed or that automatic end
is programmed then no further input from the user is required. Simply place the logger
where it is required to log temperature and leave it.
7.0 Retrieving Data from EV loggers
When downloading is required the logger must be be activated, using the navigation button
on the front of the logger, and placed in the interface (face down for EV loggers and face up
for EVt loggers). To stop a logger in manual mode press and hold the navigation button for
six seconds. The word LOG will disappear from the LCD (where tted on the logger) and the
logger will play a series of beeps. In automatic mode the logger will stop automatically at the
programmed time.
If Auto docking is active the software will automatically detect the logger and begin the
download process, see below:
When the data has been downloaded the software will automatically lter the task database, if
displayed, for the current logger type, its serial number and the current task programmed to it,
and it will automatically draw the graph with the settings as in the
current task.
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7.1 Important Note regards EV Pro and 21 CFR Part 11
If a logger has been programmed on a PC running EV Pro software, it will only be
possible to to use that logger on the same PC or another PC which is also running
EV Pro software. This is to protect the data in accordance with 21 CFR Part 11.
8.0 Graphing Data/Calculations
After the data has been downloaded the software will automatically graph the data for the
session just downloaded. Please refer to the main user guide, which can be found in Help-
User Guide in the software.
9.0 Printing
Data from the graph can be printed in a number of ways. Please refer to the main user guide,
which can be found in Help-User Guide in the software.
10.0 Exploring the Database
10.1 Database Description
All the tasks for all the loggers known to the software and all the session information is
stored in the database.
Select Task Database or Split Screen Icon to view the database.
The database is split into two sections. On the left is a list of all the tasks and on the right
is the session information. When a logger is downloaded and information stored, a new
session is created. The number of sessions created or possible per task is determined
by how the logger was used.
If a logger in manual start stop mode is started and stopped many times, but not
downloaded, then each block of data will create a new session of data.
If a logger logs continuously until its memory is full, and wraparound is off, the task will
be completed when the data is downloaded. The data will be either a single block, and
therefore a single session, or if it has been stopped and started again then multiple
sessions are possible. To use the logger again will require the creation of a new task.
If a logger logs automatically from time X to time Y then the task will be closed when the
logger is downloaded and a single session will be created.
If a logger is logging in daily logging mode until its memory is full then the task will be
closed. If the logger has logged for more than one day then each day will become a
session of data.
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10.2 Editing Tasks/Sessions
After a task has been created it can only deleted if it has not been programmed into
a logger. Once it has been programmed to a logger it can not be deleted, but only
archived.
Certain elements of the task can be edited after the task has been written, whether or
not the data has been downloaded.
These include:
Description
Graph Scale
Graph Max and Min
Graph Line Colour and Line Width
MKT/Lethality and Pasteurisation Values (EV Pro Only)
These will not affect the downloaded data except in the way they are presented and how
some of the calculations are performed on the data.
Editing sessions includes only adding/changing the session description.
10.3 Task Useful Information
The tasks include useful summary information about the data after it has been
downloaded.
This information includes:
Description
Model
Serial Number
Created Date/Time
Data Start Date/Time
Date End Date/Time
Channel Summary
Daily Days Summary
Alarm Summary
Created By (EV Pro Only)
Modied Date/Time (EV Pro Only)
Modied By (EV Pro Only)
*External Task Yes/No (EV Pro Only)
*If a data logger that has been programmed with a task by another PC is introduced to
the current PC data in the logger will still be downloaded, but a task will be created by
the software from the data in the logger. This task will be marked ‘External’ to identify
that it was created on another PC.
Tasks can be viewed/reviewed from the database by double clicking on them individually.
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10.4 Filtering/Sorting Tasks/Sessions
For EV Standard users there is a reduced ltering set. Please refer to section 10.4 of the
user guide within the software.
At this point it is possible to lter and sort the task database. To select a lter option tick
the appropriate box then select/enter the lter criteria. Note: Items below marked #
relate to EV Pro only.
Status Filter - The tasks will be ltered by one of three options; Unused, Active and
Closed.
Task ID - Everything except a specic task in the database can be ltered out.
Task Description - Use this lter to lter out tasks with a specic description or one that
contains a word or phrase.
Session Description - Use this lter to lter out tasks with a specic session description
or one that contains a word of phrase.
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Model - Use this lter to show only those tasks that apply to a particular model type.
Serial Number - Show all the tasks for a particular logger serial number, i.e. a specic
individual logger.
#Data Date Range - It is possible to lter the tasks by data date range by entering two
dates - "from" and "to".
#Data last n Days - Filter by the most recently downloaded data.
#Creation Date Range - Filter tasks by created date range by entering two dates -
"from" and " to".
#Creation Last n days - Filter tasks by the most recently created task.
#Created By - Filter tasks by Users/Administrators who have created them.
#Modied Date Range - Filter tasks by when they were modied by selecting two dates
- "from" and "to".
#Modied last n days - Filter tasks by those modied most recently.
#Modied By - Filter tasks by User/Administrator who modied them.
#Channel - Filter tasks by those with a certain active channel.
#Above Value - Filter Tasks/Sessions by parameter and scale above a certain value.
#Below Value - Filter Tasks/Sessions by parameter and scale below a certain value.
#Daily Logging Days - Filter tasks by those with daily logging days. Any combination of
days may be selected.
In High or Low alarm - Filter the tasks to show only those with readings in either high or
low alarms.
In High Alarm - Filter the tasks to show those with readings in high alarm.
In Low Alarm - Filter the tasks to show those with readings in Low Alarm.
#Externally Created - Filter tasks that were originally not generated on the
current PC.
Primary Sort/Secondary Sort - The results can be sorted by:
Task ID
Task Description
Generic Model
Serial No
Date start date/time
Date end date/time
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10.5 Filter Recall
It is possible to recall a previously used Filter without the need to set up the lter again.
Using the Task Database view or the split screen view click on the drop down menu at
the bottom of the task database list to reveal the last used Filters. See example below:
It is possible to set up a number of favourite lters which can then be recalled at anytime
without the need to set them up again.
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11.0 Mean Kinetic Temperature/Lethality/Pasteurisation
(EV Pro Only)
It is possible via the task set up to enter values for:
Mean Kinetic Temperature
Lethality
Pasteurisation
Please refer to the user guide within the software for more information on the calculations for
MKT/Lethality and Pasteurisation.
12.0 21 Title CFR Part 11
12.1 What is 21 CFR Part 11?
The FDA (Food and Drug Administration) in the USA, issued regulations Title 21 CFR
(Code of Federal Regulations) Part 11 that provide criteria for acceptance by FDA or an
approved regulatory body, for the acceptance of electronic records, electronic signatures,
and handwritten signatures executed to electronic records as equivalent to paper
records and handwritten signatures executed on paper. These regulations, which apply
to all FDA program areas, are intended to permit the widest possible use of electronic
technology, compatible with the FDA’s responsibility to promote and protect public health.
Part 11 applies to any record governed by an existing FDA predicate rule that is created,
modied, maintained, archived, retrieved, or transmitted using computers and/or saved
on durable storage media. In other words any record from a data logger, for instance that
is at some stage stored on a PC or where a PC is used to retrieve the data, 21 CFR Part
11 can be applied.
12.2 Title 21 CFR Denitions
Electronic Record - Any combination of text, graphics, data, audio, pictorial or other
information representation in digital form, that is created, modied, maintained, archived,
retrieved or distributed by a computer system.
Electronic Signature - A computer data compilation of any symbol or series of symbols,
executed, adopted or authorised by an individual to be legally binding equivalent of the
individual’s handwritten signature.
Digital Signature - An electronic signature based upon cryptographic methods or
originator authentication, computed by using a set of rules and a set of parameters such
that the identity of the signer and the integrity of the data can be veried.
Closed System - An environment in which system access is controlled by persons who
are responsible for the content of electronic records that are on the system.
Open System – An environment in which system access is not controlled by persons
who are responsible for the content of electronic records that are on the system.
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Standard Operating Procedures (SOPs) - Guidelines and rules dened by the
organisation implementing Title 21 CFR Part11 compliance to instruct users what they
are and are not permitted to do and how they are to perform the relevant tasks.
EV Professional Software - The EV Professional Software includes a number of settings
and data protection devices that, when used with with the EV, EVG and EVt series
of data loggers, will give the user a compliant system if adopted into their SOPs. The
software can control the access to areas of the software by individual user by means of
Administrators who can set up and allocate individual users with their own unique access
levels to the software. However it is always the responsibiltiy of the organisation to make
sure that any particular user is responsible and understands that any document he/she
signs using this software under a 21 CFR environment is the equivalent of a handwritten
signature. It is important that you enter the information into these two boxes that will
provide the correct amount of information for future viewers of the task.
12.3 Electronic Signatures (EV Pro Only)
To be compliant with the requirements of 21 CFR Part 11 Electronic Signatures have
been added to the EV Pro software.
When deciding when to sign a task it is important to remember what state the task is in
before signing and there are a number of rules that need to be recognised before signing
should take place:
Any task that is signed will be closed.
When a task is closed there may still be a logger that has yet to be docked and have
data downloaded. The consequence of this is that the data from that logger will no longer
be associated with this task, but will have a new task assigned that is deemed to be
externally created.
Once a task has been signed it cannot be modied in any way. Users must accept the
current graph settings for this task as they cannot be changed once the task is signed.
This includes the task description.
A signed task will include both the name of the signer and an encryption code which
will be stored with the task. This allows anyone to know that the task has been signed
correctly. This is particularly important when emailing archive databases to another user.
The code can only be recognised by other users with the Pro version of the software. It
allows another user to be sure that the task was properly signed.
Users must ensure that the task they select to sign is the correct one, because once a
task has been signed it is saved as a unique record and cannot be changed.
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Use the mouse to left click the required task in the list of tasks. The selected task will be
highlighted in blue.
Select Tasks > Sign Task to bring up the dialog box above.
If the current user's name is not shown as the current user, select the required user
name from the dropdown list. Enter the password for the current user. The task is not
signed at this time.
Press OK to continue.
There are two text boxes to be completed, Authority to Sign and Reason for Signing
Authority to Sign is for the user to note his/her authority to sign.
Reason for signing is for the user to note his/her reason for signing.
It is possible to sign a task that has no data associated with it.
When both boxes have some text then the ‘sign’ option will become active. Only when
this option is clicked on will the task be signed and closed.
Once signed the task will appear in the task database with a Key symbol in the ‘S’
column for signatures.
12.4 Audit Trails (EV Pro Only)
As part of the changes to bring the software into line with the requirements of 21 CFR
Part 11 there is an extensive Audit trail within the software.
This shows full and partial history of what took place with the software. Only users with
specic access to the Audit trail can view it or indeed access the ltering and reporting
functions included.
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Select View/print Audit trail:
It is now possible to view the current Audit trail for the software.
The Audit trail shows by date/time the action completed, the user, user ID, Task ID and
Session ID.
There are a number of lters for the Audit Trail:
• Date Range
• User
• Task ID
• Session ID
• Maximum number of readings to display.
The ltered results are then exportable to Excel.
The results can be printed in either detailed form or as just the summary information.
The audit trail for any given database will be saved when archived so that it can be
reviewed when the archive database is reviewed.
12.5 21 CFR Part 11 Policy Statement
Comark does not at any time imply that the use of this software package and Comark
EV loggers will automatically give the customer protection and compliance with 21 CFR
Part 11. The EV Pro software from Comark is designed to be integrated into the SOPs
as part of a 21 CFR Part 11 system. A number of tools have been put into place in order
to provide an excellent basis for complying with the requirements of 21 CFR Part 11.
If the SOPs are updated to include the use of EV Pro and loggers then compliance is
not guaranteed but it will be more likely. In any case the system in place will need to be
discussed with an FDA Auditor. EV Pro and EV data loggers are a vital link in the path to
compliance.
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Comark Instruments
52 Hurricane Way
Norwich, Norfolk, NR6 6JB England
Tel: 01603 (+44 1603) 256647
Fax: 01603 (+44 1603) 256644
Email: service@comarkltd.com
Website: www.comarkltd.com
Comark Instruments
PO Box 9090, Everett,
WA 98206, USA
Tel: (503) 643 5204
Fax: (503) 644 5859
Email: sales@comarkUSA.com
Website: www.comarkUSA.com
© Comark Instruments Part Nº 18080 Issue 4 (08/10)
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