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

Dr. Wingate is Quality Director at GSK.  He has held a range of operational and corporate roles in GlaxoSmithKline’s Global Manufacturing & Supply.  These include overall responsibility for quality for one of GSK largest manufacturing sites, responsibility for corporate QA Technology Strategy, leading a major revision to the GSK corporate Quality Management System, and overall responsibility for Computer Validation standards and implementation.  Dr Wingate has maintained responsibility for regulatory advocacy of computer validation and electronic record and electronic signature compliance since 1998 he joined GSK to head up a new multi-site computer validation department. 

Dr Wingate has worked with a number of regulatory authorities including FDA and MHRA since the early 1990s to help them develop regulatory requirements and inspection strategy (e.g. co-author of highly influential ISPE white paper on risk based approach to electronic records and signatures which lead to revision of US 21 CFR Part 11 regulation). His personal experience of computer validation covers engineering project management, quality technology, auditing, and validation.  He is a Chartered Engineer, a Member of the ISPE, a Member of the PDA, and a Member of the lEE.  He holds a B.Sc., M.Sc., and PhD. from University of Durham in Computing, Advanced Electronics and Engineering Science respectively. 

Dr. Wingate is widely published 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", "Validating Corporate Computer Systems: Good IT Practice", and more recently “Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance” all published by CRC/Interpharm Press. Dr. Wingate was the founding Chairman of the Supplier Forum for providers computer systems, software and associated services to the pharmaceutical industry, and has chaired the GAMP Forum's Council and Industry Board since 2000.  Dr. Wingate is also Visiting Lecturer for the University of Manchester's M.Sc. course on Pharmaceutical Engineering Advanced Technology (PEAT) and Institute of Dublin’s M.Sc. course on Validation Sciences.