Annex 11 provides guidelines for good manufacturing practice (GMP) for medical products. The current version was approved in 2011 and it will be updated in order to add detailed principles for more relevant areas still uncovered, since there have been not only an increased use of computerised systems but also an important progress in the use of new technologies (i.e. Artificial Intelligence & Machine Learning algorithms within GxP software). The draft version of the Concept Paper on the revision of Annex 11 has already been released in Dec 2022. Computerised System Validation is an essential part of the pharmaceutical industry: it ensures that products are safe, effective and meet the required quality standards.
The regulatory requirements commonly defined in a risk-based approach validation are the provisions set forth by the 21 CFR Part 11 & EU cGMP Annex 11 rules, so that the next version of Annex 11 is expected to affect the validation strategy, related deliverables, and testing acceptance criteria.
The aim of this article is to describe the improvements introduced by the Annex 11 review (see Concept Paper on the revision of Annex 11 of the guidelines on GMP for medical products – Computerised Systems) and the possible implications related to a risk-based approach validation in order to ensure the system compliance for the following topics: