Quality assurance of computerized systems


The course is aimed at those who work with computerized systems and need an overview of Good Automated Manufacturing Practice (GAMP).

Computerized systems are an essential part of the life science industry, from research and development to clinical trials, manufacturing and distribution. Computerized systems used in the GxP environment must be reliable and adapted to their needs.

Good Automated Manufacturing Practice (GAMP) is a guideline for the quality assurance of computerized systems using risk-based validation according to a life cycle model and specifically designed by experts in the pharmaceutical industry to support the HUR and the interpretation of regulatory requirements and to improve compliance and quality, efficiency and cost reduction.

This course gives you an understanding of regulatory requirements and how computerized systems should be quality assured in an effective way. After the training, you should have gained an overview of the content of GAMP 5 with a focus from a perspective for you as a specifier, client, supplier and manager of system solutions, for GxP and MDR regulated activities.