| Selling
products of the food and beverage industry as well as pharmaceuticals
on a global market nowadays can only be achieved by producing
them according to the rules of Good Manufacturing Practice
(GMP).
These are set out in the regulation 21 CFR Part 11
by the Food and Drug Administration (FDA) of the USA. FDA regulations
are also valid within parts of fine chemical industry, as they
produce raw materials for the industries mentioned above.
The requirements which have to be fulfilled by technological
solutions can be summarized under three topics:
- Access Security,
- Audit Trail,
- Archiving and Retrieval
With WinCC Version 6.0 and the options WinCC/Audit and
SIMATIC Logon additional components have been introduced
that further simplify the validation of systems.
- All relevant data which are stored electronically are protected
against unauthorized changes
- The system provides secure, computer-generated, time stamped
audit trails to record actions that create, modify or delete
electronic records.
|
 |
