Ba Atmocontrol FDA en d30396
Ba Atmocontrol FDA en d30396
MADE IN GERMANY.
[Link]
Manufacturer and customer service
Memmert GmbH + Co. KG
Willi-Memmert-Straße 90–96
D-91186 Büchenbach
Deutschland/Germany
Phone: +49 (0)9122 925-0
Fax: +49 (0)9122 14585
E-mail: sales@[Link]
Internet: [Link]
Customer service:
Service hotline: +49 (0)9171 9792 911
Service fax: +49 (0)9171 9792 979
E-mail: service@[Link]
Update
The current version of AtmoCONTROL and this manual are available for download at
[Link]/de/service/downloads/software/.
Contents
1. End user licence agreement 6
2. Introduction 8
2.1 Description............................................................................................................................ 8
2.2 Supported MEMMERT appliances and parameters............................................................. 9
2.3 Advanced functions of the AtmoCONTROL FDA version..................................................... 9
3. Installation 11
3.1 System requirements.......................................................................................................... 11
3.2 Installing AtmoCONTROL................................................................................................... 11
4. Working with AtmoCONTROL 12
4.1 Starting AtmoCONTROL..................................................................................................... 12
4.2 Program interface............................................................................................................... 13
4.2.1 Menu bar.......................................................................................................................... 14
4.2.2 Toolbar.............................................................................................................................. 15
4.2.3 Status bar......................................................................................................................... 15
4.3 Installing the device licence................................................................................................ 16
4.4 Adding and disconnecting devices.................................................................................... 16
4.4.1 Adding device connected via Ethernet............................................................................ 16
4.4.2 Connecting a device using a USB storage medium......................................................... 16
4.4.3 Connecting a device using database file......................................................................... 17
4.4.4 Displaying device and licence information...................................................................... 17
4.4.5 Disconnecting devices...................................................................................................... 17
4.4.6 Log file.............................................................................................................................. 18
5. Program 19
5.1 Editor window.................................................................................................................... 19
5.1.1 Overview.......................................................................................................................... 19
5.1.2 Creating a program.......................................................................................................... 19
5.1.3 Setting parameters........................................................................................................... 21
5.1.4 Available parameters....................................................................................................... 22
5.2 Simulating the program sequence (preview)..................................................................... 27
5.2.1 Working in the preview window..................................................................................... 27
5.3 Saving, loading, transferring and running the program................................................... 29
5.3.1 Saving the program......................................................................................................... 29
5.3.2 Loading a saved program................................................................................................ 29
5.3.3 Transferring program via Ethernet................................................................................... 29
5.3.4 Transferring a program via USB storage medium........................................................... 29
5.3.5 Selecting and starting a program on the appliance........................................................ 30
5.4 Program examples.............................................................................................................. 31
5.4.1 Program example with clock timer.................................................................................. 31
5.4.2 Program example with door locking............................................................................... 32
5.4.3 Program example sterilisation......................................................................................... 33
5.4.4 Program example loop..................................................................................................... 34
6. Protocol 35
6.1 Importing protocols........................................................................................................... 36
6.1.1 Importing protocol from network................................................................................... 36
6.1.2 Importing protocol from USB data medium................................................................... 36
6.2 Comment protocol............................................................................................................. 36
6.3 Exporting a protocol........................................................................................................... 37
6.3.1 Export in PDF format........................................................................................................ 38
6.3.2 Export in Excel format...................................................................................................... 39
6.3.3 Export in CSV format....................................................................................................... 41
6.4 Statistics.............................................................................................................................. 43
7. Printing 43
8. Options 44
8.1 Set language and temperature unit................................................................................... 44
8.2 Display device log file in the protocol window.................................................................. 44
8.3 USER-ID............................................................................................................................... 44
8.3.1 Description....................................................................................................................... 44
8.3.2 Use.................................................................................................................................... 45
8.4 Calibrating thermoshelves (vacuum oven VO)................................................................... 46
8.5 Sending emails................................................................................................................... 46
8.5.1 Sequence.......................................................................................................................... 47
8.6 Backup Options.................................................................................................................. 48
8.6.1 Backup of the protocol data/device database................................................................. 48
8.6.2 Backup of the program profiles *.atpro ......................................................................... 48
8.6.3 Backup of the user administration.................................................................................. 48
8.6.4 Audit Trail......................................................................................................................... 48
8.6.5 Method............................................................................................................................ 49
8.6.6 Restore............................................................................................................................. 49
9. FDA functions (menu item Security) 51
9.1 User management.............................................................................................................. 51
9.1.1 Adding and deleting users and manage user rights....................................................... 51
9.1.2 User administration options............................................................................................ 52
9.1.3 Changing the user password and user............................................................................ 52
9.1.4 Lock flag for permanent locking of a user....................................................................... 52
9.1.5 Comment function........................................................................................................... 53
9.2 Signing a document........................................................................................................... 53
9.3 Traceability by means of a protected audit trail file........................................................... 54
9.4 Locking AtmoCONTROL..................................................................................................... 55
10. Event codes of the log file 56
The user must employ the SOFTWARE PRODUCT only for his own purpose unless expressly
agreed otherwise.
The user must notify MEMMERT GmbH & [Link] without delay of any faults which occur,
together with a brief description of the fault.
§4 - RESTRICTED WARRANTY
MEMMERT GmbH & [Link] warrants for a period of 1 year that the data medium on which
the SOFTWARE PRODUCT is supplied, is free from material faults and manufacturing faults.
The software has been carefully developed and tested by MEMMERT GmbH & [Link]. There
is however no warranty that the functions of the software meet all expectations or that the
software runs without any interruptions.
MEMMERT GmbH & [Link] is not liable for any damage, lost profit, loss of confidential or
other information, interruption of business, personal damage, loss of privacy, breach of duty,
including duties in good faith or duty of care, property or other damage which may arise from
the use of this software product or any inability to use this software product.
This applies also in case MEMMERT GmbH & [Link] has been advised of the possibility of such
damage.
This exclusion does not apply to damage which has been wilfully caused by MEMMERT GmbH
& [Link].
§5 - TERMINATION
Irrespective of other rights MEMMERT GmbH & [Link] is entitled to terminate this licence
agreement if you contravene in any form the terms and conditions of this licence agreement.
In such a case you are obliged to return all originals and copies of the software product to
MEMMERT GmbH & [Link]. Copies in whatever form and on whatever data medium must not
be retained. In so far as MEMMERT GmbH & [Link] waives the obligation to such return, you
must destroy all originals and copies and this destruction must be documented and proven.
§6 - DAMAGE LIMITATION OBLIGATION
1) The licensee is expressly advised that he has to produce security copies of the data on his
computer regularly and at adequate intervals of time (normally weekly). If he does not do this
he defaults on his obligation to limit damage. The licensor is not liable for damage arising
from such contravention.
2) The licensee is expressly advised that the software must not be employed in dangerous
environments which presume fault-free operation (high-risk activities such as operation of
nuclear installations, weapon systems, aircraft navigation or communication systems or life-
preserving machines). If he still does so he defaults on his obligation to limit damage. The
licensor has not liability for damage arising from such default.
§7 - AGREEMENT ALTERATIONS AND DEFENCE CLAUSE
The agreement is concluded exclusively on the basis of the General Utilization Conditions of
MEMMERT GmbH & [Link]. Other agreements are inapplicable, even if certain regulations are
not included in the Utilization Conditions of MEMMERT GmbH & [Link].
§8 - CHOICE OF LAW
All legal relations between the parties, including delict law, are subject to the law of the Ger-
man Republic. The legal domicile is Büchenbach, Germany.
§9 - FINAL CLAUSE
1) Supplements to this agreement, including this clause, have to be produced in writing.
2) If one or several of the above terms should be or become invalid, this does not affect the
effectiveness of the other terms. The invalid term is to be replaced by a valid term which as far
as possible realizes the intended commercial purpose This also applies in case of a gap in the
agreement.
3) This agreement is subject to the law of the German Republic. Legal domicile is the domicile
of the licensor. All questions relating to the validity, interpretation and performance of the
contents of this agreement should be clarified at the legal domicile of the licensor in the Ger-
man Republic.
2. Introduction
2.1 Description
AtmoCONTROL is a software for programming and logging MEMMERT appliances of the
generation 2012 of appliances (from October 2012) with Ethernet and/or USB interface and
corresponding equipment.
With AtmoCONTROL, you can
► graphically create, modify and save programs on your computer with various parameters
and transfer these to the appliance (description from page 19);
► read out, organise and document the internal log memory of appliances (description from
page 35);
► configure user authorisations on USER ID USB sticks, with which the manual adjustment
of individual or all parameters on the appliance can be prevented (description from page
44).
21 CFR Part 11
The regulation 21 CFR (Code of Federal Regulation) part 11 came into force in 1997. It
describes the American Food and Drug Administration’s (FDA) requirements for electronic
records and electronic signatures for their use instead of elaborate paper documentation and
handwritten signatures. The stimulus for its creation came from the pharmaceutical industry.
It applies to all companies in pharmaceutics, biotechnology and medical technology produc-
ing in the US or shipping to the US.
Manufacturers of FDA-regulated products, in particular of pharmaceutical and chemical prod-
ucts, are under a strict validation obligation. The US agency stipulates continuous documenta-
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
signed electronically.
They are stored in:
► Electronic records
► Audit trails
► Electronic signatures
The FDA compliant software AtmoCONTROL FDA edition fulfils the requirements for the use of
electronically stored datasets and electronic signatures defined in regulation 21 CFR part 11 by
the US Food and Drug Administration (FDA):
► Authenticity: The users and administrators of electronic records must be uniquely identifi-
able and authentic.
► Integrity: The data of electronic records have to allow unique inferences about the process-
es documented by them. Any modifications must be continuously documented through-
out the archiving period.
► Non-repudiation: The electronic signature, inseparably connected to the electronic record,
must uniquely identify the author responsible
• Unique identification of the user
• User-related access protection for individual system functions
• Safety of data against manipulation
• Automatic audit-trailing with timestamp, signature and type of modification to the
electronic records
• Human readability and machine readability of electronic records
• Access option to data for the inspectors of regulatory authorities
3. Installation
3.1 System requirements
Category Minimum system requirements
Processor Pentium 1 GHz
Main memory 1 GB
Available free space on
4 GB
hard drive
Graphics Colour monitor with at least 1200 x 800 px resolution
Interfaces an available USB or Ethernet interface
Operating system Windows 7, Windows 8, Windows 10
Software PDF Reader to display the help menu
In addition, all logged-on users must have write access to the directory C:\ProgramData\
Memmert and its subdirectories. These rights are granted during installation.
NOTICE
AtmoControl may only be started in one instance, nor can multiple Windows
users operate in parallel on the same computer. The use of AtmoControl with
multiple parallel instances can lead to uncontrolled behaviour.
2 3 4 5
4.2.2 Toolbar
The toolbar provides rapid access to the most important menu functions:
1 Create a new (zoom in)
program 5 Reduce view
2 Load program from (zoom out)
the data 6 Show full
1 2 3 4 5 6 7 medium program
3 Save new 7 Select time range to
program display
4 Enlarge view
1 2 3
Device Program Protocol Print Options Security Help
Fig. 1
An appliance of type ICO 50 (1), named “Laboratory” (2) by the user, is registered via Ethernet
(3) in AtmoCONTROL; current operating status (4)
A description of how to set the IP address is provided in the user manual of the
corresponding appliance.
4. Click on Upload to start transferring the licence. The appliance can now be added (regis-
tered) in AtmoCONTROL as described in the following section.
A description of how to set the IP address is provided in the user manual of the
corresponding appliance.
If you click on Connect now, the device is added to the status bar and you can create pro-
grams for it or read out protocols.
When connecting, all data are automatically updated.
A description of how to export protocol data from a device is provided in the user
manual of the corresponding device.
A B C D
5. Program
5.1 Editor window
5.1.1 Overview
In the Editor window, programs can be created: sequences of various parameters (e.g.
temperature, pressure and humidity), which the appliance then implements from a definable
point in time.
To be able to create a program in AtmoCONTROL, the appliance which is to perform the pro-
gram must be listed in the status bar and selected (clicked on). The appliance can, but does
not have to, be connected to the computer via the network. If the appliance is not yet listed in
the status bar, it must be added (see page 16).
5.1.2 Creating a program
Select the appliance that will later perform the program by clicking on it in the status bar (Fig.
2, No. 1). An icon bar with the available parameters (functions) for this appliance is shown (2,
description from page 22). Additionally, one or two editor threads (3 and 4) are displayed,
depending on the appliance. The program sequence is determined on these.
Two editor threads are always shown for appliances with humidity or pressure control,
and one editor thread for all others.
Bear in mind that the two editor threads are not synchronised. This means that a specific X
position on one thread does not match the same position on the other thread in time. If you
want to see the parameter values for a specific point in time, you must change to the simula-
tion mode (see page 27).
If you want to create a time correlation to a specific point, use the "Sync" function (see page
26).
1 2
To create a program, drag the individual parameter icons onto the editor thread one after
another in the desired order, while holding down the left mouse button (Fig. 3 and Fig. 4). To
assist the correct positioning, a red insertion mark is displayed at the insertion position. With
the zoom icons in the toolbar list (see section 4.2.2 on page 15) or with the mouse wheel,
you can zoom in or out of the display or have the entire program displayed.
Ramp 05 10
11 h:00
30 m LIGHT
Ramp 05 10
11 h:00
30 m
21.0 °C 180
180.0 °C 0%
21.0 °C 180
180.0 °C Increase 2 h:30 m
Fig. 3 Fig. 4
Drag the parameter icon (in this case a tem- Drag other parameters – light and a humidity
perature change) onto the editor thread while change in this case – onto the editor thread.
holding the mouse button down A red insertion mark helps you to find the
correct position.
The temperature icons (change/hold temperature) may only be placed on the upper editor
thread, humidity and pressure icons only on the lower one.
The meaning of the individual icons and the adjustment options are described from page
22. You can find some simple program examples from page 31.
Removing a parameter icon from the editor thread
To remove a parameter
icon (and therefore its
function) from an edi-
tor thread – if you have
inserted it by mistake, for
example – select it and,
with the mouse button
depressed, move it to the
recycle bin symbol on the
lower right (Fig. 5).
Fig. 5
To delete a parameter icon from an editor thread, drag the icon,
with the mouse button depressed, to the recycle bin symbol.
2
Tolerance band Tolerance band
3
0,1 K/min 0,1 K/min
1
Fig. 6 Further adjustment options fold down after clicking on the arrow icon on the right
edge of the window (1)
0 to 20 percent
50%
STAND BY
CO
? 2 15
For a setpoint ≠ 0.0, the fan is automati-
cally set to 50 %.
15 0
O
CO22
STAND BY
? O2 1 to 20 percent 15
12.0 %
FAN
0 to 100 percent in steps of 10 %
STAND BY
100 %
?
position steps of 10% 15
100 % (For program example, see page 33)
LIGHT
UV LIGHT
STAND BY
UV light on/off 15
on off
SWITCH
A STAND BY
Switches a switching contact (A, B or C) on or
Switch 15 off at the insertion position
close open
DEFROST
STAND BY
Activates the defrosting function of the appli-
Defrost
15 ance at the insertion position
CLOCK TIMER Here, the day(s) and the time at which the
Mo Tu program is to be performed, can be adjusted.
STAND BY
We Th
15 Clock timer Fr The program is repeated each week at the
Sa Su specified times.
11 h:30 m
(For program example, see page 31)
Day 18
Here, the date and time at which the pro-
STAND BY
gram is to be performed, can be adjusted. In
15 Calendar Month 05
Year 2012 contrast to the clock timer, the program is run
- -h:-30-mm
22 only once.
SYNC
15 Loop
... ...
JUMP LOOP
4X TARGET
JUMP
TARGET
LOOP
4X 2X
STAND BY
Switches all appliance functions off at the
5 Standby
insertion position
GAS INLET
Inert gas/ ? Switching between fresh air supply and inert STAND BY
?
Fresh air gas (vacuum oven VO) 15
InertGas FreshAir
► To zoom in on a certain section, click and drag with the left mouse button to draw a rec-
tangle over the section you want to see (Fig. 8). If the selection is shown in red, the section
is too small to be shown. In this case, make the rectangle larger until its colour changes to
light grey.
► If you want to see a time range longer than two days, click on the rightmost symbol of the
top toolbar (Fig. 9). This will open a window in which you can select the time range you
want to see.
+
Fig. 8 Fig. 9
Zooming into a time range by drawing a Selecting the time range manually
rectangle
► To move the displayed time range (x axis), move the mouse cursor to the right or left edge
of the graph window. Arrows will appear with which you can move the displayed section
to the left or to the right (Fig. 10).
► To only scale the time axis (x axis) or the value axis (y axis), move the cursor to the label of
the respective axis. The cursor will turn into a double arrow. Scroll with the mouse wheel
to scale the respective axis (Fig. 11).
Fig. 10 Fig. 11
Moving the time range to the left or right Scaling the time or value axis by scrolling as
soon as the mouse cursor turns into a double
arrow
How programs are selected and started on the appliance is described in the user
manual for the appliance.
If the appliance is connected to the computer via the network, the respective current operat-
ing status can be monitored in the status bar of AtmoCONTROL (see page 15).
With appliances that have humidity control, make sure that the water supply tank of the
appliance is filled before the program start. Check the level of the tank at regular intervals,
especially for programs that run for long periods. The same applies for appliances with gas
supply.
1 4 5 8
2 3 6 7
4
120 °C
3 7
50 °C
20 °C 8
Fig. 13
The appliance heats up from Monday to Friday (1) at 8 am (2) to 120 °C (3) and continues to
maintain this temperature (infinitely ∞) (4) until it is changed: also Monday to Friday (5) at 6
pm (6) to 50 °C (7) – again continued (infinitely ∞) (8) until it is changed again in the morning
at 8 am (2).
3 4
Tolerance band
1,7 K/min
1 2 5 7 8 6
1 6
95 °C 3
2 5
45 °C
20 °C
12:00 h ≥ 0:30 h
Fig. 14
The door is locked at the beginning of the program (1). Then, the appliance heats up to 95.0 °C
(2) and maintains this temperature for 12 hours (3). Subsequently, the temperature is lowered
(5) for 30 minutes (4) to 45.0 °C and then, the door is opened (6). The setting "SPWT on" (8)
ensures that the door is opened only when the temperature really has dropped to 45.0 °C,
even if this takes longer than 30 minutes. Below the temperature change is shown in K/min (7).
4 6
Tolerance band
1 2 3 5
1
0% 100 % 0%
2
100 % 0 %
6
180 °C 4 7
3
20 °C
3:00 h
Fig. 15
At the beginning, the fan is switched on to 100 % (1) and the air flap is closed (0 %) (2). Then,
the appliance heats up to 180.0 °C (3) and maintains this temperature for 3 hours (4). The set-
ting „Safe“ (5) ensures that the sterilisation time does not start (6) before the set tolerance band
(7) is reached and is restarted if it is exceeded.
1 4
Unload
7 2 3 5 6 8 9
3 6
0% 80% 0% 80% 0% 80% 0% 80% 0% 80% 0% 80% 0% 80% 0% 80% 0% 80% 0% 80% 0% 80% 0%
250 °C
2 5
20 °C
1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h 1h
1 4
Fig. 16
First, the appliance heats up to 250.0 °C (2) for one hour (1). Then, the fan begins to run at 80
% power (3) and the temperature is lowered for one hour (4) to 20.0 °C (5). Subsequently, the
fan is switched off (6). This sequence is repeated from the jump target (7) ten times (8).
6. Protocol
In the protocol window, you can now see a graphic representation of the chronological
sequence of set and actual values of the device highlighted in the status bar (temperature,
humidity, fan, etc.). The information displayed may vary depending on the functions of the
respective device.
2 3
4
5
6
1
In the protocol window, you will find the same functions (zoom, etc.) as in the program
simulation (see page 27).
Measured values that are too small to be shown and seen normally, are represented as
small circles. They are shown normally as you zoom in.
How protocols on the device are exported to USB storage media is described in the
user manual of the appliance.
If the entire log period is not saved to the USB stick, data gaps may occur in AtmoControl
under certain circumstances. This can be remedied by saving the log of the current year or
the entire log of the device to a USB stick again and importing it into AtmoControl,
depending on the size of the gap.
1. Connect the USB storage medium with the exported
protocols to your computer/laptop.
2. Click on Protocol Import and select the data medium or
directory where the protocols are saved. All appliances
(serial numbers) for which there is protocol data on the
data carrier (and in its subfolders) are displayed.
You can find the serial number of the appliance on its
type plate.
3. Select the appliance or the appliances for which you
want to import the protocols and click on Import. If you
activate Register after import, the selected appliance will
be automatically registered in AtmoCONTROL once the data has been imported. Other-
wise, you will have to register the appliance manually (see page 16) to view and analyse
the imported protocol data in AtmoCONTROL.
6.4 Statistics
With the function Protocol Statistics, you can calculate
the temperature statistics for the protocol period dis-
played on the monitor (minimum, maximum, average,
mean kinetic temperature [MKT], etc.). With Results to
clipboard, you can, for example, paste the values into a
text editor.
7. Printing
With the Print function, you can print out programs in the editor window, as well as simula-
tions and protocols – depending on what is currently displayed. You can print as a graph or a
table.
8. Options
8.1 Set language and temperature unit
Select Options Language or
Options Temperature Scales to set the user
interface language (German or English) and
the temperature unit (Celsius/Fahrenheit). To
change the temperature scale, restart
AtmoCONTROL.
8.3 USER-ID
8.3.1 Description
With the appliances listed in the table on page 9, it
is possible, with the help of an encrypted "USER-ID" file
on a special USB stick (Fig. 20), to lock functions of the
appliance or to restrict them in their operation. You can User-ID
8.3.2 Use
1. Insert the USER-ID USB stick with the USER-ID file into the
computer with AtmoCONTROL.
2. In the Options menu bar, click on USER-ID.
If access to the „Delete program“ controller function is to be blocked, this can be done by
blocking „Select program“.
Fig. 21
You get most of the necessary settings from your
Settings for the automatic sending of
Internet service provider (ISP). In particular, the
emails in case of alarm events
parameters mean:
Parameters Description
Outgoing mail server. Usually this address begins with "smtp."
SMTP Server
Example: [Link]
IP port number of the SMTP server; Number greater than 0 and
less than 65536. Usually port 25, may also be 587. You will
Port
receive the information from your ISP. Port number 465 is out of
date.
Login name for the SMTP server. Provided by the ISP. This is not
User name the login for the operating system nor the user name for Atmo-
CONTROL FDA. It is often an email address.
Parameters Description
Password for the SMTP server. Provided by the ISP, but may have
Password
been changed in a password change dialog box.
"From" or "Sender" of an e-mail. Possibly your ISP is expecting an
Sender
e-mail address here.
User-friendly name, or short name for the "Sender". Often ap-
pears in e-mail programs instead of the sender's e-mail address.
Display name
Example:Sender = atmocontrol@[Link], display name =
AtmoCONTROL
E-mail address(es) of the recipient(s) of AtmoCONTROL alarm
messages. Multiple addresses can be specified, separated by a
Mail receiver
comma. Example:fred@[Link], control@cccom-
[Link]
SSL = Secure Sockets Layer. This is a cryptographic protocol to
Enable SSL ensure data integrity and security between sender and receiver.
Tick if possible.
Activate E-Mail delivery Forwarding can be activated and disabled.
Test settings When the button is clicked, a pseudo-e-mail will be sent.
8.5.1 Sequence
After receiving a log record online, the temperature, humidity, CO2 and O2 (if available), and
alarm types are displayed or updated in the appliance list on the left side of AtmoCONTROL
for the corresponding appliance. The system then checks whether e-mail forwarding is acti-
vated (tick box in the e-mail settings).
Then, if more than 10 minutes have passed since the last e-mail was sent, e-mail delivery is
started. The 10-minute delay to prevent too many emails being sent. If the alarm disappears
within 10 minutes, no email is sent.
8.6.5 Method
The log databases are backed up automatically in the backup directory at set intervals (in the
above example every 24 hours, so daily). This is done after a multi-stage multi-generation
backup process, which is also known as “Towers of Hanoi”. This results in only a few copies,
but there are always backup copies, which are at the most 1, 2, 4, 8, 16,... intervals apart - so
days old in the above example.
In this way, backup copies can be used for a basically arbitrary point in time, so that re-
covery is possible even for errors that have not been discovered for a long time. The data-
base copies are identified by the appliance serial number and -L01 for level 1 (level L01).
Example:[Link]. The next copy receives the identifier L02, the third -L01 again,
etc. (Fig. 22).
Example:
On 27/11 an error is detected on appliance B3120001. The error probably happened on or
after 24/11.
Backup files sorted by modification date (newest first):
[Link] 26/11.
[Link] 25/11.
[Link] 23/11.
[Link] 19/11
....
In this case the backup copy [Link] of 23/11 restores the desired state, as it is
the last one created before the suspected date of the error - 24/11.
A direct backup of the log databases by copying the *.atdbx files may only be performed
if the associated appliances are not logged in - either online or offline - otherwise the con-
sistency of the databases is not guaranteed. However, integrated automatic data backup
is only performed during online connections and ensures the consistency of the database
copies.
B C D E F
Fig. 23 User management in the AtmoCONTROL FDA edition
Here, you can:
► grant and revoke individual rights to each user and block users Ⓐ
► change existing user passwords Ⓓ
► add new users Ⓔ
► delete users Ⓕ (user names not reusable later, already assigned passwords should not be
reused after deletion)
Use the scroll bar Ⓑ to see other user rights.
The user management can only be accessed by users the administrator has assigned the
right to do so.
You cannot use any of the last three passwords when setting a new password.
The “Display” button changes in the background to the selected time range in the log view.
Using an electronic signature in the sense of 21CFR11 requires additional notification of
the responsible authority in accordance with 11.110(c).
The user rights assigned by the administrator define the
type of signature a user is allowed to provide. The sig-
natures are divided in the roles created, seen, checked,
approved and responsible.
A user can also sign with several roles, however only with
the corresponding rights. A role can in turn also be signed
by several users with the right to do so. It is possible to
give different signatures for different time ranges.
englisch