Food & Drug Administration (FDA)

FDA logo

The FDA is the USA authority for licensing drugs and is under the Ministry of Health. The FDA was founded in 1927 with headquarters in Rockville (Maryland).

The FDA's task is to protect public health in the USA. It regulates the safety and effectiveness of human and animal pharmaceuticals, biological products, medical products, food and radiating devices. The regulations apply to products produced in the USA and imported products.
The FDA is comparable in Germany with the TÜV and Ministry of Health.

Important regulation for Siemens AG products
On August 20, 1997, the FDA's rule 21 CFR Part 11 on electronic records and signatures came into force. 21 CFR Part 11 (in brief: Part 11) defines the acceptance criteria of the FDA for the use of electronic records and signatures instead of drawings in paper form and handwritten signatures on paper.

The requirements include the following:

• Validation
• Records of operator actions
• Retention/Protection/Reproducibility/Retrievability
• Access protection
• Electronic signature (certification of equality)

Detailed information on the single products and solutions are available at the following links:

• Information on WinCC in Entry ID: 37940022
• Information on WinCC flexible in Entry ID: 37939984
• Information on the panels in Entry ID: 37940461

Further information
More information on the topic of GMP (Good Manufacturing Practice) is available at the following link:
http://www.automation.siemens.com/pharma

Additional Keywords
Certificate, Directives, Laws

Description
A general description on the subject of the Food and Drug Administration is available in Entry ID: 37939948.

Solutions in WinCC flexible
WinCC flexible provides the following options and solutions to fulfill the FDA regulations:

• Access protection
• Audit Trail
• Electronic signature

Access protection
Access protection is ensured by the software package SIMATIC Logon (central user administration) and the local user administration.

Examples of local user administration:

• The individual users and their assignment to user groups are defined in the WinCC flexible configuration.
• Authorizations with authorization levels based on the user groups are defined in the user administration of WinCC flexible.
• Password aging is supported; you can configure the length of password validity and the number of generations.
• The user logged on is automatically logged off by the system after a configurable period of time if there is no activity during that time.

Examples of SIMATIC Logon:

• The administrator ensures central user administration (enabling, disabling, locking, unlocking, assigning to user groups).
• Unique combination of user ID and password.
• Definition of access rights for groups and users.
• Password aging
• Initial password
• The user is blocked automatically after a configurable number of failed log-on attempts and can then only be unblocked by the administrator.
• Automatic log-off
• Log functions

More information on the topic of SIMATIC Logon is available here.

Audit Trail
The Audit Trail is provided by the WinCC flexible/Audit option. WinCC flexible/Audit is for monitoring operator activities in Runtime mode.
Below are examples of fulfilled requirements.

• Process data (process values, process and operator messages, for example) is stored without the operator being able to make any changes.
• Relevant changes made by the operator in the HMI system during operation are recorded in an Audit Trail.
• Storage of data in a CSV file.
• Display of evaluation by the "Audit Viewer" (only on PC systems).

Using the WinCC flexible Change Control option it is possible to record changes in the WinCC flexible projects, for example, changes to archive and alarm displays and graphics, definition of access rights etc.

Electronic signature
WinCC flexible permits users to sign actions electronically. In the Engineering phase, among other things, tags are defined and any changes made to them in Runtime must be confirmed with an electronic signature. The electronic signature may consist of entering a password and a comment. The changes are also recorded in the Audit Trail.

Further Information
More information on the topic of GMP (Good Manufacturing Practice) is available at the following link.
http://www.industry.siemens.com/verticals/global/en/pharma-industries/gmp-validation/Pages/Default.aspx

Additional Keywords
Certificate, Directives, Laws

Description:
A general description on the subject of the Food and Drug Administration is available in Entry ID: 37939948.

Solutions for panels:
Panels provide the following options and solutions to fulfill the FDA regulations:

Stainless steel fronts:
Devices with stainless steel fronts have the following special features:

• Front (stainless steel 1.4301, polyester foil)
• Surface (brushed finish, 240 grit, EPDM gasket)
• Optimized frame profile
• Sloping surfaces without front-mounted USB interface
• Rear-mounted tensioning frame

Access protection:
Access protection is ensured by the software package SIMATIC Logon (central user administration) and the local user administration.
Examples of local user administration:

• The individual users and their assignment to user groups are defined in the WinCC flexible configuration.
• Authorizations with authorization levels based on the user groups are defined in the user administration of WinCC flexible.
• Password ageing is supported; you can configure the length of password validity and the number of generations.
• The user logged on is automatically logged off by the system after a configurable period of time if there is no activity during that time.

Examples of SIMATIC Logon:

• The administrator ensures central user administration (enabling, disabling, locking, unlocking, assigning to user groups).
• Unique combination of user ID and password.
• Definition of access rights for groups and users.
• Password ageing
• Initial password
• The user is blocked automatically after a configurable number of failed log-on attempts and can then only be unblocked by the administrator.
• Automatic log-off
• Log functions

More information on the topic of SIMATIC Logon is available here.

Audit Trail:
The Audit Trail is provided by the option WinCC flexible/Audit. WinCC flexible/Audit is for monitoring operator activities in Runtime mode.
Below are examples of fulfilled requirements.

• Process data (process values, process and operator messages, for example) is stored without the operator being able to make any changes.
• Relevant changes made by the operator in the HMI system during operation are recorded in an Audit Trail.
• Storage of data in a CSV file.
• Display of evaluation by the "Audit Viewer" (can run only on PC systems).

More information on the topic of WinCC flexible/Audit is available here.

Note:
The "Audit" option can be used for operator panels as from xP270.

Electronic signature:
WinCC flexible permits users to sign actions electronically. In the Engineering phase, tags are defined and any changes made to them in Runtime must be confirmed with an electronic signature. The electronic signature may consist of entering a password and a comment. The changes are also recorded in the Audit Trail.

Note:
More information on the topic of FDA regulations is available here.

Further Information:
More information on the topic of GMP (Good Manufacturing Practice) is available at the following link:
GMP -Webcast & Testiminials

Keywords:
Certificate, Directives, Laws

Introduction
This FAQ entry describes what to pay attention to with regard to licenses and authorizations for WinCC flexible. This entry covers licenses for panels, WinCC flexible ES and WinCC flexible RT.

Please follow the instructions in the PDF file (Attachment 1). The following points are covered in the document.

1 General Information about Licenses
   1.1 License, Certificate of License and License Key
   1.2 Why Do You Need Licenses?
   1.3 Available License Types
   1.4 Licenses for Options and Services of WinCC flexible ES/RT
2 How Do You Transfer Licenses?
   2.1 Which Software is Needed?
   2.2 How Do You Transfer License Keys?
   2.3 Transferring License Keys to an Operator Panel via Automation License Manager
   2.4 Removing License Keys from an Operator Panel via Automation License Manager
3 License Key Backup
   3.1 Which Software is Needed?
   3.2 When Do You Have to Back Up License Keys?
   3.3 Backup and Restore
4 Upgrading Licenses
   4.1 What Is a License Upgrade and What Types Are There?
   4.2 Requirements for an Upgrade
   4.3 Upgrading Using the Automation License Manager
5 Special Features of WinAC MP
   5.1 License Keys for WinAC Types
   5.2 License Keys for WinAC Versions.
   5.3 Other Special Features
   6 Frequently Asked Questions
   6.1 How Do You Repair a Defective License?
   6.2 Why is a License Invalid After Changing Time Zones?
   6.3 Why are License Keys Not Recognized?
   6.4 Where is the "Old" License Key Located after an Upgrade?
   6.5 How Do You Retrieve a Lost License Key?
   6.6 Why are Licenses from TP 177 Not in the Backup?
   6.7 Can You Use a License for WinCC flexible 2008 also for WinCC flexible 2007?
   6.8 Can You Change the Versions of WinCC flexible by Replacing Licenses?
         (This does not apply for Micro and China Edition)

Attachment 1: WinCC_flexible_Lizenzen_en.pdf ( 922 KB )

Attachment 2 lists the licenses required for the various options and services in WinCC flexible Runtime (RT) and WinCC flexible Engineering System (ES).

Attachment 2: License_Key_List_e_V1_1.pdf ( 15 KB )

Keywords
License repair, License destruction, License installation connection, License upgrade, ALM, Automation License Manager, License defective, License not recognized

Description:
In order to prevent access via Telnet in panel devices of the 27x / 37x series with WinCC flexible and thus possible manipulation of archive files, e.g. Audit Trail archives, the option "Telnet Login Disabled" must be installed.

Validity:
You can use this option for the Standard and Advanced editions of WinCC flexible 2005. The functions described are guaranteed only if you install the option completely.

Installation notes:
In order to disable the Telnet utility on the operator panel you must transfer the "Telnet Login Disabled" option to the operator panel. As from ProSave 7.3.3 this option is available in the "Options" tab.

Transferring Telnet Login Disabled with ProSave (Standalone) to an operator panel
You transfer Telnet Login Disabled as follows with the "Standalone" version of ProSave:

1. Start ProSave via "Start > SIMATIC > ProSave > ProSave".
2. In the "General" tab you select the operator panel type and the corresponding connection.
3. Switch to the "Options" tab.
4. In the "Available Options" tab you select the "Telnet Login Disabled" item.
5. Click on the ">>" button. "Telnet Login Disabled" is now transferred to the connected operator panel. The Telnet utility is disabled automatically after the transfer.

Notes on transfer:
If you transfer an option to a device that is not configured properly, the following message might be displayed after transfer: "Could not execute application! Transfer will be started.". This message refers only to the missing configuration. The option will be transferred error-free.

Notes on enabling the Telnet utility:
In order to enable the Telnet utility again you remove the "Telnet Login Disabled" option from the operator panel with ProSave.

Link to the download:
The download of the ProSave service tool is available in Entry ID 10347815.

Keywords:
TP 270, OP 270, MP 270B, TP 277, OP 277, MP 277, Mobile Panel 277, MP 370

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)