Entry type: FAQ, Entry ID: 37939984, Entry date: 08/29/2013
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What support does Siemens AG offer to make use of WinCC flexible, WinCC flexible Runtime and panels that can be configured with WinCC flexible comply with FDA regulations?

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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
  • Change Control
  • Electronic signature

Stainless steel fronts (panels)
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 (Runtime, Panels)
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 (Runtime, Panels)
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).

Change Control (Engineering System)
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 (Runtime, Panels)
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.automation.siemens.com/mcms/pharma-industries/de/gmp-validierung

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Certificate, Directives, Laws, 37940461