Memmert CELSIUS 10 FDA User Manual
Benutzerhandbuch "CELSIUS 2007 FDA-Edition"
USER MANUAL
CELSIUS 10
Control software for MEMMERT appliances – FDA Edition
Validatable in according to 21 CFR Part 11
U. S. Food and Drug Administration
Willi-Memmert-Straße 90–96
We reserve the right to make changes
About this manual
This user manual describes the installation and use of the MEMMERT control software CEL-
who have the task of programming/operating MEMMERT ovens.
The representation of the programme windows in this manual is based on the operating
Explanation of terms
Term Meaning
Tempering
a time sequence of physical values/combinations
vacuum, CO
and O
), that the oven should perform
vacuum, CO
and O
), that the oven should create during
the execution of a tempering profile (measuring values)
ated, edited or stored by a computer system.
Audit Trail
Any editing of an Electronic Record must be protocolled
with time, user name and type of alteration and must be
aid of the
Audit Trail it is possible to follow the history of
any document.
that he has edited an Electronic Record. For this it is nec-
authority can be tested. “Electronic Signatures“ are not
Description
on/from page
4
and familiarise yourself with it.
This manual should always be kept in a place where those working with the software have
access to it. It is the responsibility of the operator to ensure that persons who work with or
will work with the software are informed as to the whereabouts of this user manual. We rec-
An electronic version of this manual in
).
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4. Programme description 16
4.1 Starting CELSIUS
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4.2 Start screen and licence file
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4.2.1 Language
4.2.2 Menu bar
4.2.3 Toolbar
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This end user licence agreement forms a legally binding agreement between you, whether a
This licence agreement bindingly regulates the use of software licences of MEMMERT GmbH
as in online or electronic format (“software licence“). Included are also all updates and sup-
agreement without requiring any separate agreement.
your legally binding agreement that you accept the conditions of this licence agreement and
are bound by it. If you do not agree to the conditions of this licence agreement you are not
The software is protected by copyright laws, international copyright agreements, as well as by
The software product is licenced, not sold. All property and user rights remain with MEMMERT
accompanying printed material and of any copy of the software product are and remain with
are however not authorised to duplicate or distribute the printed material accompanying the
The software product is licenced as follows:
As customer you must use the software only for the MEMMERT equipment entered in the
You are not entitled to hire out, lease, loan or otherwise dispose of the software product. You
are also not authorised to amend, back-develop, decompile, disassemble etc. the software
technological development. The user hereby notes this situation.
All warranty lapses if the user modifies programmes or programme parts or has such changes
from incorrect operation, use of unsuitable operating material, or unusual operating condi-
tions.
The user must employ the SOFTWARE PRODUCT only for his own purpose unless expressly
agreed otherwise.
The user must notify MEMMERT GmbH & Co.KG without delay of any faults which occur,
together with a brief description of the fault.
the SOFTWARE PRODUCT is supplied, is free from material faults and manufacturing faults.
The software has been carefully developed and tested by MEMMERT GmbH & Co.KG. There
the use of this software product or any inability to use this software product.
This applies also in case MEMMERT GmbH & Co.KG has been advised of the possibility of such
This exclusion does not apply to damage which has been wilfully caused by MEMMERT GmbH
agreement if you contravene in any form the terms and conditions of this licence agreement.
from such contravention.
The agreement is concluded exclusively on the basis of the General Utilization Conditions of
All legal relations between the parties, including delict law, are subject to the law of the Ger-
as possible realizes the intended commercial purpose This also applies in case of a gap in the
agreement.
Description
With CELSIUS, you can
form.
values. up to eight ovens can be controlled via RS-232 or USB, and if RS-485 or Ethernet
and protocols from a
type, temperature, humidity, vacuum, CO
2
2
) including
Advanced FDA Edition functions
Within a closed system this specially developed software meets the FDA requirements. The
►
trail
thority management, user and password management, user authentification)
21 CFR Part 11
The regulation 21 CFR (Code of Federal Regulation) Part 11 came into force in 1997. It
tion) in respect of electronic data sets and signatures so that they can be used as replacement
for extensive paper documents and manual signatures. The initiative for their development
The regulation applies to all production and quality assurance documents which previously
They are filed in:
Audit Trails
)
The FDA conform software “CELSIUS FDA-Edition“ meets the requirements for the use of elec-
tronically stored data sets and electronic signatures as laid down in the directive 21 CFR Part
Authenticity: user and administrator of Electronic Records must be uniquely identifiable
and authentic.
vation period.
Automatically operating audit trail with time stamp, signature, and type of alteration
►
►
►
►
►
►
►
Category Minimum system reqirements
Available free space on hard
yes
VGA graphics and colour monitor
an unused RS-232 or
Windows XP, Vista, 7
Windows® NT security concept of software manufacturer Microsoft. The core operating sys-
tem of Windows NT was successfully tested by NCSC ito security level C2 of the orange book
Oven type Parameters
Incubators
CO2 incubator
2
2
Cooled incubators
)
)
)
)
)
)
)
)
Vacuum drying ovens
Vacuum drying ovens
Vacuum drying ovens
VO
Constant climate and humidity chambers
Constant climate and humidity chambers
Constant climate and humidity chambers
Climatic test chambers
TTC
Storage chambers
Storage chambers
Storage chambers
Tempera-
ture
Humidity Vacuum CO
2
O2Fan speed Servo air flap
Always first install CELSIUS before you connect an oven to your
The installation of CELSIUS FDA-Edition must be performed by the Windows system ad-
Windows users and assigning
All users of CELSIUS FDA-Edition must be established
their own user passwords.
):
assign restricted account rights to all users.
Assign restricted user rights.
You
are first requested to select the language
for the installation. Select the desired language
and confirm with OK.
The
throught the installation procedure.
You are shown the
the use of the software in German and
the installation. If you reject the license
agreement, the installation procedure is
terminated; but it can be restarted at any
time.
terms of the license, and then click on
Then you must choose the
target
the name of a folder that should be
want to install the programme itself.
Also select "
want to connect ovens via the USB
a
).
You can also install USB and chip card
additionally.
You now have the option of registering
with GLP data (GLP =
also skip this step and enter
a later date (see page
45
).
way, carry out steps 2 to 4. Click on
4.1
the desktop:
and
):
Programs
Documents
Settings
Search
Help and Support
Run
Shut down
File Edit View Favorites Extras
Back
Search
Start screen and
alteration.
The
The licence number remains unchanged if the entity name is altered or if additional equip-
The digital signature ensures that CELSIUS refuses to operate if the
tered. Without a valid
version (not FDA-version) .
The
1
Menu bar: The various processing options are given here (description from page
).
(for an explanation, see page
).
3 Information box
4 Main window: When functions have been run, you can create and edit tempering profiles
here (in graphical or tabular form, see page
27
and display logs (see page
38
).
5
Status line: A help text for the function currently chosen is displayed here, along with vari-
ous information on the current PC configuration.
Status line: A help text for the function currently chosen is displayed here, along with vari-
Status line: A help text for the function currently chosen is displayed here, along with vari-
6 Licence number under which the software is registered
2
6
3
7
4
5
4.2.1
Preset language Can be changed via ...
Ajustes
Menu bar
All programme functions can be run from the menu bar. The most important programme
functions can also be run quickly via the icons of the tool bar (see page
). The individual
functions and how they are run are described below.
As long as no oven is logged in, only general programme parameters can be changed and
call via
A possible existing profile will be
a profile that
file
Save Tempering
To File
to a file
To Device
to the internal memory of the oven
To Internal
To External
which has been transferred from
the ring protocol memory of the
call via
Save Protocol
To File
a tempering profile
was started,
the log file
this after the sequence has been
41
The tempering profile in the active
window is printed. Depending on
the display type currently selected
a graphic (including possible log
values) or as a table (without log
values). The exact screen contents
are printed here. The printout is
The printout is done as in
tempering profile,
tempering profile is printed out –
time axis is selected according to
the current screen display.
45
Show GLP Data
45
Transmit GLP
troller of the oven. The
appear in the GLP header on each
45
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