Sion Wyn, Director, Conformity Ltd., is an acknowledged expert in computer system validation and compliance and international regulations. He is the editor of the Good Automated Manufacturing Practice (GAMP®) Guide for Validation of Automated Systems, and is a member of the GAMP Council and the GAMP Europe Steering Committee.

He is currently assisting FDA with their re-examination of 21 CFR Part 11, and is member of the team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He is the technical content expert for the FDA ORA Virtual University on-line training modules on Computerized Systems Validation and Compliance. He recently received the FDA Group Recognition Award as a member of the Part 11 Team.

He has extensive experience in all aspects of computer systems validation and compliance, including managing validation projects, validation planning, specification and testing of systems, performing site and system compliance audits, writing SOPs, performing 21 CFR Part 11 assessments, and supplier audits.

As a specialized validation consultant, Wyn’s expertise covers all stages of the lifecycle approach to validation of computerized systems and most system types including MRPII, manufacturing execution, electronic document management, EBRS, process control and monitoring, environmental monitoring, manufacturing equipment, and laboratory systems.

At Conformity Ltd., Wyn provides computer validation and compliance consultancy to the pharmaceutical and other regulated life-science industries.