New Revised EU GMP Annex 11

The EC has announced a new revision of EU GMP Annex 11 Computerised Systems. There are also associated changes to EU GMP Chapter 4 Documentation. Annex 11 has been revised in response to the increased use of computerised systems and the increased complexity of these systems. The Annex defines EU requirements for computerised systems, and applies to all forms of computerised systems used as part of GMP regulated activities. This is a major revision, which has a significant impact on all GMP regulated companies.

Significant aspects include revised and enhanced requirements covering quality risk management, system inventory, supplier assessment, periodic evaluation, and many topics covering system operation. At the conclusion of this session, participants will be able to:

  • Understand the changes to Annex 11
  • Understand why these changes were required
  • Understand what industry needs to do to comply
Sion Wyn
Conformity Ltd.

Sion Wyn, Director, Conformity Ltd., is an acknowledged expert in computer system validation and compliance and international regulations in this field. He assisted the FDA as a consultant with its re-examination of 21 CFR Part 11, and was a member of the core team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He was the technical content expert for the FDA’s ORA Virtual University on-line training modules on computerized systems validation and compliance. He received the FDA Group Recognition Award for work on Part 11. Wyn is the editor of ISPE’s GAMP5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems, and is a member of the ISPE GAMP Global Steering Committee, GAMP Editorial Board, and the GAMP Europe Steering Committee. He is lead GAMP and Computer Systems Validation and Compliance, Part 11, and Data Integrity trainer and course developer for ISPE. He has extensive experience in all aspects of computer systems validation and compliance, including validation planning, specification and testing of systems, quality risk management, performing site and system compliance audits, performing risk assessments, writing policies and procedures, performing 21 CFR Part 11 assessments, Data Integrity assessments, and supplier audits. At Conformity Ltd., Wyn provides computer validation and compliance consultancy to the pharmaceutical and other regulated life-science industries. Wyn received the 2006 ISPE Professional Achievement Award, which honours an ISPE Member who has made a significant contribution to the pharmaceutical manufacturing industry. He also received the 2016 ISPE UK Fellow Award.

Chris Clark
TenTenTen Consulting

Chris Clark has over 36 years experience of Quality Control / Quality Assurance within the pharmaceutical and other regulated life sciences industries. He is an experienced leader of teams responsible for ensuring compliance to international GxP’s. Chris has specialized experience in ensuring compliance of a wide range of computerized systems (Laboratory systems, MRP systems, Documentation Management systems, Clinical systems) and has assisted an IT service provider to develop a quality management system to support IT Service Management (ITIL®). He has a proven track record of IT Vendor and services audits. Chris is a contributor of ISPE’s GAMP® 5 Guide A Risk-Based Approach to Compliant GxP Computerized Systems, and is the Chair of the GAMP® Editorial Board, Co-Chair of the ISPE GAMP® Council, and a member of the GAMP® Europe Steering Committee. Chris contributed to the GAMP® interpretation of the revised Annex 11. Chris has extensive experience of speaking at many international seminars and conferences on the risk-based approach to compliant GxP computerized systems.

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