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:

By employing  WinCC options you can extend the WinCC basic software to a system that allows the validation of a plant according to FDA regulations.

SIMATIC Logon - Central, plant-wide user management

The user administration with SIMATIC Logon integrates into the security system and user management of Windows and thus meets the FDA requirements. SIMATIC Logon comprises a number of security mechanisms and provides a plantwide user management.
Starting with WinCC V7 SIMATIC Logon is part of the WinCC basic software.

WinCC/Audit - Creating Audit Trails

You can use WinCC/Audit whenever revision tracking of operator actions and configuration changes is required, for example in all plants with an implemented quality assurance system. Operator actions as well as changes to the project are logged in an Audit trail. WinCC/Audit has an integrated document management for the administration of WinCC configuration data (e.g pictures and functions ) as well as arbitrary customer data, providing access to older versions as well.

WinCC/ChangeControl - Project versioning and document control

WinCC/ChangeControl is a functional subset of WinCC/Audit. WinCC/ChangeControl is for tracing engineering changes in the engineering phase or in online operation. All change data is recorded in an audit trail. The document management manages system images, scripts and log layouts and customerspecific documents and stores respective intermediate versions as backups.

Compliance Response 21 CFR Part 11

In order to support a validation process we offer a whitepaper, which contains detailed answers to the FDA requirements for a plant monitoring based on WinCC.