Memmert AtmoCONTROL FDA User Manual
AtmoCONTROL
FDA Edition Validatable in according to 21CFR
Part 11 U. S. Food and Drug Administration
Version 2.X.X
SOFTWARE MANUAL
100% ATMOSAFE. MADE IN GERMANY.
www.memmert.com | www.atmosafe.net
Willi-Memmert-Straße 90–96
We reserve the right to make changes
AtmoCONTROL FDA Version
About this manual
target group
This user manual describes the installation and use of the MEMMERT programming software
AtmoCONTROL. It is intended for use by trained personnel of the operator, who have the task
to the appliance. Incorrect use could result in damage to the appliance and/or to the chamber
with AtmoCONTROL and familiarise yourself with it.
This manual should always be kept in a place where those working with the software have
will work with the software are informed as to the whereabouts of this user manual. We rec-
The current version of AtmoCONTROL and this manual are available for download at
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AtmoCONTROL FDA Version
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4. Working with AtmoCONTROL 10
4.1 Starting AtmoCONTROL
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4.2 Programme interface
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4.2.1 Menu bar
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4.2.2 Toolbar
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4.2.3 Status bar
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4.3 Installing the device licence
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4.3.1 Using a USB storage medium (only possible for PLUS appliances)
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4.3.2 Via Ethernet with AtmoCONTROL
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4.4 Adding and disconnecting devices
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4.4.1 Adding device connected via Ethernet
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4.4.2 Connecting device using USB storage
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4.4.3 Connecting a device using database file
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4.4.4 Log file
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4.4.5 Displaying device and licence information
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4.4.6 Disconnecting devices
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AtmoCONTROL FDA Version
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
your legally binding agreement that you accept the conditions of this licence agreement and
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
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
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.
AtmoCONTROL FDA Version
The user must employ the SOFTWARE PRODUCT only for his own purpose unless expressly
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
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-
AtmoCONTROL FDA Version
AtmoCONTROL is a software for programming and logging MEMMERT appliances of the
With AtmoCONTROL, you can
Appli-
the appliance itself, and FDA functions are not available.
the appliance itself, and FDA functions are not available.
ance
Temperature Humidity Pressure CO
Programmable main parameter
Fan speed Air fl ap Light*
2
AtmoCONTROL FDA Version
Advanced functions of the AtmoCONTROL FDA version
Within a closed system, this specially developed software meets the requirements of the Food
tion processes in the food, chemical and pharmaceutical industry:
►
trail
The regulation 21 CFR (Code of Federal Regulation) part 11 came into force in 1997. It
tion and long-term archiving of the process variables.
The regulation applies to all production and quality assurance documents that had to be pro-
vided signed in paper form before. These documents may as of now be created, stored and
They are stored in:
Audit trails
The FDA compliant software AtmoCONTROL FDA edition fulfils the requirements for the use of
the US Food and Drug Administration (FDA):
Authenticity: The users and administrators of electronic records must be uniquely identifi-
Automatic audit-trailing with timestamp, signature and type of modification to the
Access option to data for the inspectors of regulatory authorities
►
►
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AtmoCONTROL FDA Version
Category Minimum system requirements
Available free space on
4 GB
VGA graphics and colour monitor
Windows 7, Windows 8
You must have Windows administrator rights to be able to install the AtmoCONTROL FDA
the installation process step by step.
their rights later on (see page 33).
Working with AtmoCONTROL
Which of the following functions are available for you depends on the user rights the
AtmoCONTROL administrator has given you (see page 33).
AtmoCONTROL can be started in two ways:
AtmoCONTROL)
AtmoCONTROL FDA Version
When starting AtmoCONTROL FDA, you have to login as
AtmoCONTROL user with your user name and password. Users
you start AtmoCONTROL FDA for the first time, you are asked
whether these data should be encrypted. This is required for compliance with the FDA require-
The
1
4
Menu bar (see section 4.2.1)
3
Status bar (provides an overview of available appliances, see page 13)
Show/hide status bar
Status bar (provides an overview of available appliances, see page 13)
Status bar (provides an overview of available appliances, see page 13)
5
Editor, simulation and protocol window (only for appliances listed on page 8,
otherwise only protocol window)
Editor, simulation and protocol window (only for appliances listed on page 8,
Editor, simulation and protocol window (only for appliances listed on page 8,
Programming mode switch (for editor/simulation/protocol, see pages 24 and 30)
otherwise only protocol window)
otherwise only protocol window)
You may change the
2
3
6
5
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AtmoCONTROL FDA Version
Device Program Protocol Print Options Security Help
Connect to device via
Ethernet (see page 13)
2
protocol data on USB
storage medium (see
protocol data on USB
protocol data on USB
page 14)
3
database file (see page
4
Disconnect selected de-
vice (see page 15)
5
Disconnect all devices
vice (see page 15)
vice (see page 15)
Load a saved programme
8
Save programme
9
Save programme under a
Save programme
Save programme
new name
device via Ethernet (see
page 25)
Export programme to
page 25)
Import protocol from
page 25)
page 25)
page 30)
Export protocol data (see
page 30)
page 30)
page 31)
Print (see page 31)
guage (German/English)
page 31)
Automatic sending of
page 31)
page 31)
emails (see page 32)
Automatic sending of
Automatic sending of
Edit backup folder (see
emails (see page 32)
emails (see page 32)
page 33)
Sign a programme or
protocol electronically
Sign a programme or
Sign a programme or
34)
20
Edit user rights (FDA func-
tion, see page 33)
21
34)
22
tion, see page 34)
23
Display audit trail (FDA
tion, see page 34)
tion, see page 34)
function, see page 35)
Display audit trail (FDA
Display audit trail (FDA
24
Lock AtmoCONTROL
function, see page 35)
function, see page 35)
35)
25
Programme information
26
format
27
device (see page 13)
4.2.2
Toolbar
The toolbar provides rapid access to the most important menu functions:
programme
2
Load programme
programme
programme
from the data
Load programme
Load programme
medium
3
Save new
programme
4
Enlarge view
zoom in)
5
Reduce view
Show full
programme
Connect online via Ethernet
1
Connect offline from USB device
2
Connect offline from database
3
Disconnect device
4
Disconnect all devices
5
New
6
Load
7
Save
8
Save As...
9
Upload to Device
10
Export to USB drive
11
12
13
Import...
Export...
15
Print
14
Language
USER-ID
16
Email options
17
Edit Backup Folder
18
Sign document
19
Edit users
20
Change password
21
Change user
22
Audit trail
23
Lock AtmoCONTROL
24
25
26
27
About...
User Manual
Upload license file to device
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