Computer Validation

In the pharmaceutical industry, computer-aided systems must be qualified according to regulatory requirements (e.g. GAMP, NAMUR, 21 CFR Part 11, etc.) and automated plants and processes must be validated. The complex area of computer validation is therefore becoming increasingly important for you.

A&D AS Solutions Process Industries assists you with:

• preparation and implementation of validation concepts for new installations or extensions of GMP-compliant computer-aided plants and systems
• planning, implementation and documentation of checks
• analyses and solutions for electronic records and electronic signatures (CFR 21, Part 11)
• situation audit and risk assessment of "in-house" computer-aided systems and
• SOPs for the lifecycle of automation systems.

To meet this challenge you require a partner that understands both regulatory and operational requirements and has expert knowledge of the total lifecycle of automated systems. This includes both production data and laboratory information systems as well as other systems such as SAP.