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WinCC flexible Options -- Product information -- WinCC flexible /Audit
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What support does Siemens AG offer to make the use of WinCC flexible comply with FDA regulations?
What support does Siemens AG offer to make use of panels comply with FDA regulations?
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How can you display user actions and production data from the Audit Trail file on a panel?
How can you display user actions and production data from the Audit Trail file on a panel?
Part number:

Instructions:
The Audit Trail option can be used in WinCC flexible 2005 onwards to enable you to document production data and user actions. This data is archived in a CSV file (ASCII) and can be checked for Manipulation using the AuditViewer 200x. As from WinCC flexible 2008 SP1 you can also archive this data in a TXT file (Unicode).

Contents:

  1. Information on the AuditViewer
  2. FDA regulation and EU directives
  3. Requirements
    3.1 Runnability of Audit Trail
    3.2 License Key
  4. Archiving
  5. Configuring
    5.1 Configuring with WinCC flexible (CSV file)
    5.2 Configuring with WinCC flexible (TXT file)
  6. Download

1. Information on the AuditViewer
The AuditViewer enables you to check the Audit Trail file for manipulation. Among other things, the check includes verification of the checksum.  

Note:
You should not store the Audit Trail file again either with Microsoft Excel or any other software tool, because this would also classify the Audit Trail file as manipulated.

You can download the Audit Viewer 2005 / 2007 / 2008 free of charge in Entry 22180683. The AuditViewer 200x is also on the WinCC flexible CD or DVD.
 

2. FDA regulation and EU directives
Archiving the production data with Audit Trail is based on sector-specific and cross-sector standards. One of the main body of rules is regulation "21 CFR Part 11 on electronic records and signatures" of the US Food and Drug Administration (FDA). There are also various EU regulations for the different sectors, e.g. EU 178/2002.

Requirements for industrial production plants were established based on the FDA regulation and corresponding application according to GMP (Good Manufacturing Practice).

Note:
More information is available in the WinCC flexible Help system. Go to the "Index" item, select the keyword "Audit" and then in the "Tools" menu you open the manual on the topic of "Audit Trail" as a PDF file.
 

3. Requirements
The "WinCC flexible / Audit" option can be used as from the 270 series and can be configured as from WinCC flexible 2005.
 

3.1 Runnability of Audit Trail
The following table lists the configuration options with WinCC flexible and the storage files (storage locations) you can use (CSV or TXT).
 
Operator panel CSV (ASCII) TXT (Unicode) Configuration option
OP270 x - As from WinCC flexible 2005
TP270
MP270B
MP370
OP277 x x1) As from WinCC flexible 2005 SP1
TP277
MP277
MP377 x x1) As from WinCC flexible 2007
Mobile Panel 277 x x1) As from WinCC flexible 2005 SP1
Mobile panel 277 IWLAN x x1) As from WinCC flexible 2007 with HSP
Mobile Panel 277F IWLAN
WinCC flexible PC Runtime x x1) As from WinCC flexible 2005
1) As from WinCC flexible 2008 SP1
- Function is not supported
x Configurable

3.2 License Keys
The Audit option requires the following license keys:

  • WinCC flexible / Audit for SIMATIC Panels
  • WinCC flexible / Audit for WinCC flexible 200x Runtime

4. Archiving
Archiving the Audit Trail file is done on the panel on a slottable flash memory card or in the higher-level PC that is connected with the panel via Ethernet.
Logging can be stored in a CSV or a TXT file, whereby archiving in a TXT file is done in Unicode format. The ASCII character set is used fro the CSV file.

Note:
The ASCII character set does not support Asian characters among others. If you use languages for archiving, whose characters are not in the ASCII character set, then you should choose "File - TXT (Unicode)" as the storage location for archiving.
As from WinCC flexible 2008 SP1 it is also possible to print the Audit Trail file as a log. Configuration is done in the project tree of WinCC flexible ES under "Logs".
 

5. Configuring
In addition to recording process data of tags and recipes, you can also use the system function "NotifyUserAction" to record user-specific actions and process data.
 

5.1 Configuring with WinCC flexible (CSV file)
The following table explains the reading out of the Audit Trail via two scripts. Output is via I/O fields. With Panel PCs and WinCC flexible Runtime you can have the data displayed by incorporating controls, for example, in an integrated Excel table.
 
No. Procedure
1 Enable Audit Trail function (GMP)
  • Create a new project.
  • Open the project window by right-clicking on "Project" in the project tree and then selecting "Properties" in the pop-up menu.
  • Then you enable the option "Regulated project" under "GMP Settings".


Fig. 01 - Reguliertes Projekt aktivieren

2

Define Audit Trail settings

  • In the project tree under "Project > Operator Panel_1... > Archive" click on "Audit Trail".
  • Select the storage location "File - CSV (ASCII)".
  • If necessary, change the path of the archive file.
  • Add the system function ShowSystemAlarm" to the "Critical Low Free Storage Space Limit" event. Enter "Critical - little free storage available." as the message.


Fig. 02 - Systemfunktion hinzufügen

3

Configure user display and buttons

  • Close the "Audit Trail" tab.
  • Add one User View and two buttons.
  • Label the two buttons with "Login" and "Logout".
  • Configure the system function "ShowLogonDialog" under the "Press" event for the "Login" button.
  • For the "Logout" button you add the system function "Logout" under the same event.

Fig. 03 - Systemfunktion hinzufügen
4 Add users
  • In the project tree under "Project > Device... > Runtime User Administration" you open the "Users" tab.
     
  • Create two users, "User1" and "User2", and assign each a password, e.g.:
     
    User:      User1 Password:    101
    User:      User2 Password:    102
     
  • Assign both users to the "Users" group.
     
  • In addition, add the user "Admin2" and assign it to the "Administrators" group.
     
    User:      Admin2

    Password:    200


Fig. 04 - Benutzer anlegen

5

Open attached library

  • Download the library in Attachment 3 at the end of this entry.
  • Add the library to your project by clicking on "Library" in the toolbar.
  • Right-click to open the library's pop-up menu.
  • Click on "Library... > Open" and open the "Audit_Trail_Panel_WCF2008_SP1.wlf" library.


Fig. 05 - Bibliothek öffnen

6 Add picture and scripts
  • Add the "Table_CSV" picture to the project. For this you click on the picture in the library and drag and drop it into the "Pictures" folder in the project tree.
  • If it has not be done automatically, you use the same method to incorporate the two scripts "ReadFile_Panel_CSV" and "Sub_Table_CSV" in the "Scripts" folder.
  • In the "ReadFile_Panel_CSV" script you change the path that you specified in the "Audit Trail" (see Fig. 02) accordingly.

    Note:
    You can vary the name of the archive file between "AuditTrail_10.csv" and "Audit-Trail_10.csv" depending on the user interface language of the WinCC flexible project.


Fig. 06 - Fig. und Skripte einbinden

7

Add buttons

  • Add a button and label it "Audit Chart".
  • Then link the "ActivateScreen" system function and the "Table_CSV" picture to this button under the "Press" event.


Fig. 07 - Systemfunktion hinzufügen

8 Add message window
  • Open the "Templates" picture and add an alarm window to it.
  • In the Properties dialog of the message window you activate the alarm class "System" under "General".
  • In addition, you select the "Alarms" option for "Display".


Fig. 08 - Meldefenster hinzufügen

9 Archiving language - configurable as from WinCC flexible 2008 SP1
  • In the project tree structure under "Device Settings" you select the "Device Settings" tab.
  • For "Runtime settings" you click on the "Archiving language" selection field and select "English (United States)".

    Note:
    If the project has several languages and "Startup language" is selected, then, after each restart the Runtime is archived in the language last enabled.

Fig. 09 - Meldefenster hinzufügen
10

Start runtime

  • Transfer the project to the panel.
  • Log in with "User1" and then switch to the "Table_CSV" picture.
  • Click the "Read data" button.
  • Press the "Index" button and then, if necessary, the "+10" button.


Fig. 10 - WinCC flexible Runtime

Note:
The checksum is only displayed in this example, but not checked. You can check the checksum using the DOS tool "HMICeckIntegry.exe" or the AuditViewer.

5.2 Configuring with WinCC flexible (TXT file)
Configuring in WinCC flexible for archiving in a TXT file is done in the same way as configuring in a CS file. The only differences in the configuration are the storage location and the scripts required. The "Table_TXT" picture is also needed for listing the archive.

  1. In the configuration - see Fig. 02 - the storage location "File - TXT (Unicode)" is used instead of "File - CSV (ASCII)".
  2. You also need the script "ReadFile_Panel_TXT" for reading out the TXT file in Unicode format - see also Fig. 06. If you change the storage path in the configuration of WinCC flexible, then you might have to change the path and the file name in the script.
  3. The "Table_CSV" picture differs from the "Table_TXT" picture in that it has a different script call and a different "Scroll" function.
     

6. Download
If another path (see Fig. 02) is specified in the "Audit Trail" tab, you must change the path accordingly in the "ReadFile_Panel_CSV" or "ReadFile_Panel_TXT" script.
You must also pay attention to this in the "ReadFile_PC_CSV" and "ReadFile_PC_TXT", and "ReadFile_Chart_CSV" and "ReadFile_Chart_TXT" scripts respectively in Attachment 2. You can vary the name of the archive file between "AuditTrail_10.csv" and "Audit-Trail_10.csv" depending on the user interface language of the WinCC flexible project.

Attachment 1:
Attachment 1 contains a panel version of the sample project described in this entry. The sample project has been created with an MP377. To read out the Audit archive file you need the MP377 or, if you change devices, a panel that supports Audit Trail. The demo project also contains the readout from a TXT file (Unicode). You must change the storage location in the sample project for this version - see Fig. 02.

Note:
In the sample program with archiving in a CSV file, you must observe the "Regional Settings on the Panel". The script is written for the setting "Germany" with the list separator ";". If you change your "Regional Settings on the Panel" to "English United States", the list separator is set automatically to ",". If you do this, you must replace the ";" with a ",".

Attachment 1: WinCC_flexible_Audit_A1.zip ( 2990 KB )
(Only for panels)

Attachment 2:
Attachment 2 contains a PC version of the sample project described in this entry. In this version there is also a demonstration of how to read out the Audit Trail file into an Excel Control. The demo project also contains the readout from a TXT file (Unicode). You must change the storage location in the sample project for this version - see Fig. 02.

Notes:
If the Excel Control is not available, it is marked with a red rectangle in the WinCC flexible project. The Excel Control can be added to the toolbar via the pop-up menu (right-click) under the "Own Controls" category, if it is installed on the PC. If you do not have the ActiveX Control "Microsoft Office Spreadsheet 11.0", then delete the ActiveX Control and the "ReadFile_Chart_CSV" and "ReadFile_Chart_TXT", and "Script_Buttons_CSV" and "Script_Buttons_TXT" respectively from the project.

Attachment 2: WinCC_flexible_Audit_A2.zip ( 3230 KB )
(Only for PCs)

Attachment 3:
Attachment 3 contains the WinCC flexible library that is used in this entry. This library includes the scripts used as well as "Table_CSV" and "Table_TXT" pictures with the I/O fields.

Attachment 3: WinCC_flexible_Audit_A3.zip ( 5553 KB )  

Runnability and test environment:
The following table lists the components that have been used to create this entry and verify the functions described.
 
Components Product and version designation
PC operating system Microsoft Windows XP SP2
Standard tools -
Engineering tool -
HMI software WinCC flexible 2008 SP1
HMI system MP377 and WinCC flexible RT (PC version)

 Entry ID:24327008   Date:2009-04-27 
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