MODULE 11

Computer systems validation

Aims

The aims of this module are:

• to provide an understanding of computer validation concepts related to process control systems and computerised analytical equipment.
• to provide an awareness of the historical development of computer validation practices.
• to provide an understanding of the computer validation lifecycle.
• to provide an understanding of how validation relies upon pre-determined specifications, traceability of requirements through design to testing, and maintenance of validation under change control.
• to provide an understanding of how computer validation protocols are developed, integrated, managed, executed and reported.
• to provide an understanding of the impact of electronic records/signature requirements related to computer validation.
• to provide an understanding of how the computer validation effort fits into the overall validation programme.

Learning Outcomes

On completion of this module the student should be able to:

• describe the principles and practices of computer validation.
• describe how these principles and practices apply to process control systems for stand-alone and embedded control systems.
• describe how these principles and practices apply to computerised analytical equipment, both commercial off the shelf and bespoke systems.
• describe the contribution of computer validation to the regulatory requirements.
• list the type of documents required to support computer validation.
• describe how the Validation (Master) Plan, the system definition and boundaries, and impact assessment affect the validation activities.
• define the computer validation strategy for different computer systems using the GAMP software categories.
• develop a validation policy for computer systems.
• develop validation procedures for computer systems.
• describe the role of training, suppliers and contractors in the validation process.
• describe the activities needed to maintain the validated status of a computerised system.
• describe the role of authors, reviewers, approvers, witnesses for documentation.
• describe the role of plans and summary reports in the validation process and how these can be integrated into process/equipment validation deliverables.
• describe how statistical techniques can be used to support computer validation.

Tutor Information

Dr GUY WINGATE

Director - Global Computer validation, GlaxoSmithKline

Dr Wingate is responsible for computer validation of business systems, process control systems and laboratory systems within GlaxoSmithKline's manufacturing and supply operations which cover over 120 different geographic locations world-wide. He was previously Validation Manager for GlaxoWellcome’s UK secondary manufacturing business. Before that Dr Wingate was Validation Manager at ICI Eutech. His personal validation experience covers process control systems, laboratory systems, MRP II and document management systems. Dr Wingate has also led Six-Sigma projects looking to improve the effectiveness and efficiency of validation processes and projects. He is a Chartered Engineer, a Member of the ISPE, a Member of the PDA, and a Member of the IEE. He holds a B.Sc., M.Sc., and Ph.D. from University of Durham in Computing, Advanced Electronics and Engineering Science respectively. Dr Wingate has published papers widely on the subjects of dependability and validation of computer systems in journals and books, and regularly chairs and speaks at validation conferences in the UK and Europe. He is author/editor of “Validating Automated Manufacturing and Laboratory Applications" and “Validating Corporate Computer Systems" and "Computer System Validation: Quality Assurance, Risk Management, and Regulatory Compliance" all published by Interpharm Press. Dr Wingate was the founding Chairman of the Supplier Forum for providers of computer systems, software and associated services to the pharmaceutical industry, sits on the GAMP Forum’s Steering Committee and Chairs its Global Council and Industry Board. Dr Wingate is also Tutor for the University of Manchester’s M.Sc. course on Pharmaceutical Engineering Advanced Technology (PEAT), and European GMP Advisor to Serentec Publications.