FDA-Compliance -
Ready for validation with WinCC flexible

Good Manufacturing Practice

The requirements which have to be fulfilled by technological solutions can be summarized under three topics:

• Access Security
  (incl. electronic signature)
• Audit Trail and change logs
• Archiving and Retrieval

SIMATIC WinCC flexible 2007 together with the options WinCC flexible/Audit ,WinCC flexible/ChangeControl  and SIMATIC Logon offers everything you need to simplify the validation of machines and plants.

• All changes to the system are logged in detail, whether it is in Runtime mode (Audit trails) or in configuration (change logs).
• All relevant data which are stored electronically are protected against unauthorized changes

WinCC flexible thus provides a most convincing and comprehensive answer to the requirements in these industries- especially for applications close to the machine based on Panels and Multi Panels  (Series 270 devices and higher). Audit makes it easier to construct machines for these branches of industry, since the important functions to meet these requirements are already offered as-standard, which means that it is possible in this way to qualify individual machines or standalone plant sections at the suppliers‘

WinCC flexible Options for FDA Validation

WinCC flexible/Audit -
Recording of operator inputs in Audit Trails
In operation, the system records all relevant changes to tags and any operator actions in accordance with Good Manufacturing Practice (GMP) as Audit Trails and saves them to a CSV file.
You can provide additional prompts for an electronic signature and a commentary in the case of operator actions.
It is possible to visualize in a userfriendly way the Audit Trails that are registered in the project using a Viewer. Tracking changes in manufacturing processes by means of Audit Trails is possible from 270 Series Panels onwards.
further information about WinCC flexible/Audit

WinCC/flexible/ChangeControl –
Versioning and change tracking of projects
Once a plant has been commissioned and validated, it may be necessary to make changes to the configuration due to the plant being adapted or extended. Using the WinCC flexible/ChangeControl option, you can record all the changes to a plant from the start of production for the entire service life and, with software in particular, you can document reproducible versions and even carry out a rollback.
further information about WinCC flexible/ChangeControl

SIMATIC Logon
Central, plant-wide user management
The user administration with the SIMATIC Logon option integrates into the security system and user management of Windows and thus meets the FDA requirements. SIMATIC Logon comprises a number of security maechanisms and provides a plantwide user management
further information about SIMATIC Logon

PM-OPEN IMPORT
When running WinCC flexible in combination with a central WinCC system, PM-OPEN IMPORT offers the possibility to import the WinCC flexible archives(data logs, alarm logs and audit trails) automatically into the WinCC system. Thus these data can be archived for a long time period in a SQL Server database format while WinCC flexible uses CSV files for archiving.
further information about PM-OPEN IMPORT

Compliance Response 21CFR Part11
In order to support a validation process we offer a whitepaper, which contains detailed answers to the FDA requirements  for a machine monitoring based on WinCC flexible.
Download of  whitepaper:

English version 0.6 MB

version francais 0.6 MB

Additional information:

"The new ease of traceability" - Download of essay published in 12/2005 "Panels ready for validation" - Download of essay published in 05/2005 "Ready for validation" - Download of essay published in 01/2005