In this online course, you will study the basic computer system lifecycle model including activities and software quality assurance practices in each phase, from data integrity and security measures, such as back-up archiving and retention requirements for data management systems with product and financial impact. For example, manufacturing execution systems (MES), laboratory information management systems (LIMS), electronic document management systems (EDMS), and enterprise resource planning (ERP) or manufacturing resource planning/material requirement planning (MRP). At the conclusion of this session, participants will have knowledge of:
- Data management systems with product and financial impact (for example, manufacturing execution systems (MES), laboratory information management systems (LIMS), electronic document management systems (EDMS), and enterprise resource planning (ERP), or manufacturing resource planning/material requirement planning (MRP)
- The basic computer system life cycle model and the activities and software quality assurance practices in each phase
- Integrity and security measures, such as back-up, archiving, and retention requirements
Attendance suggested for:
- Years in industry: 0-4 to 5-14
- Ideal audiences are those with 2+ years of industry experience that want to supplement their industry knowledge about a specific topic(s).
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.