COMPUTERIZED SYSTEMS IN GXP ENVIRONMENTS

COURSE OBJECTIVES: Computerized systems have become the backbone of GxP operations, yet validation practices around them face pressure from two directions. On one side, regulators are modernising expectations through draft revisions to EU GMP Annex 11 and Chapter 4 and a proposed new Annex 22 on Artificial Intelligence, together with the move towards Computer Software Assurance, signals a shift from document volume towards demonstrated assurance and critical thinking. On the other side, techn

Computerized systems have become the backbone of GxP operations, yet validation practices around them face pressure from two directions. On one side, regulators are modernising expectations through draft revisions to EU GMP Annex 11 and Chapter 4 and a proposed new Annex 22 on Artificial Intelligence, together with the move towards Computer Software Assurance, signals a shift from document volume towards demonstrated assurance and critical thinking. On the other side, technology itself is moving faster than most quality systems were designed to handle, with cloud and SaaS platforms, continuous delivery, and now artificial intelligence and machine learning entering GxP-relevant processes. The result is familiar to most quality and IT compliance professionals: validation packages that grow year after year without providing oversight, supplier documentation that nobody dares to leverage, audit trail reviews that are defined but never performed at scale, and AI pilots that stall because nobody can say how they will be validated or governed. This course addresses those challenges over two intensive days. Participants will work through a risk-based lifecycle approach grounded in ISPE GAMP 5 (2nd Ed.), examine how CSA thinking can be applied without weakening compliance, and build a practical framework for validating and governing AI applications in regulated environments. Data integrity anchors Day 1 and recurs in the supplier and AI discussions on Day 2. Day 1 ends with a group workshop on data integrity and system risk; Day 2 ends with a separate workshop on AI validation and governance, followed by a summary and Q&A. Participants are encouraged to bring their own situations to the discussion