Description

Selling pharmaceuticals on a global market nowadays can only be achieved by producing them according to the rules of Good Manufacturing Practice (GMP). The most popular and important rules are set out in the regulation 21 CFR Part 11 by the Food and Drug Administration (FDA) of the USA. These so-called FDA regulations are also valid within parts of cosmetics and fine chemical industry, as they may produce raw materials for the pharmaceutical industry as well.
The requirements which have to be fulfilled by technological solutions can be summarized under three topics:

• Access Security

• Audit Trail

• Archiving and Retrieval

 
SIMATIC WinCC flexible  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.

SIMATIC Logon for WinCC flexible

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.

WinCC flexible/Audit

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.

WinCC flexible/ChangeControl

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.

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.

Compliance Response 21CGR Part 11

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.
(see links on the right)