Computerised systems that illustrate or control quality-relevant processes are in widespread use throughout the pharmaceutical industry. Not only are they subject to the requirements of the various collections of pharmaceutical regulations for the validation of these systems, but since 1997 the US authority FDA lays down requirements concerning electronic records / electronic signatures in 21 CFR Part 11.
In the GMP Certification Programme “Computer Validation Manager” participants obtain a comprehensive knowledge of the basic principles for the validation of computerised systems, the requirements of Part 11 and specific aspects of the validation of computerised systems.