Many people consider computer validation to be a “necessary evil” and not a “rewarding adventure,” but my experience over the past 20 years has disproved this dire view. It has shown that a common sense approach to the discipline of computer validation for regulated systems can give many significant rewards in data credibility for authorities, reliable system performance for end users, and pride in system quality with uneventful inspections and audits for validation teams, QA/QC, and management.
Computer validation is not a casual experience. It is a formal practice designed to provide system owners with documented evidence that their system reliably performs as expected and is in compliance with all relevant regulations, laws and authority guidance. For the pharmaceutical, biotech, and medical device industries, the major areas for such regulations and guidance are Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and other electronic record keeping and submission practices (Part 11, etc.). “GXP” is the term I use for convenience to refer to any and all the relevant regulations for computer systems.
In writing my new book, Computer Validation: A Common Sense Guide, I decided to look at the discipline of computer validation from the perspective of the people who have to participate and actually do the work in a computer validation project. This starts with the end user manager responsible for the regulated work process who decides that a system is needed and funds the requisition, purchase, validation, deployment, and ongoing operation of the system. The laws that this manager must comply with as well as the organization’s corporate infrastructure provided to perform computer validation in an auditable and cost-effective fashion are also important parts of this book.
It is the broader context of corporate governance and non-IT people required for a successful validation project that separates this book from its other brethren in the industry. The ten chapters speak clearly and directly to the roles and responsibilities for all concerned from management, user team, and IT infrastructure role, to the roles for system supplier, QA/QC, and electronic archivist. Chapters also describe the content of an inspect-able validation package and formal testing practices. Each chapter has one or many appendices giving examples of real project documentation that illustrate the concepts discussed.
Consistent, documented training is always an issue for validation teams. This book is also available in electronic chapter units suitable for focused team training locally and at a distance. Each month on this blog I will highlight concepts from this book, sharing insight and excerpts from my book and experience from my global consulting practice to support your success in validating computer systems.
Next Month: Computer Validation from the Business Management Perspective
Proposals that include new automation or substantial computerized applications in GXP areas without including a specific schedule, cost, and personnel estimate for validation should not be approved until those factors are added for consideration. If the figure for validation is less than 40-50% of the purchase price of the computer hardware and software, it should be questioned closely. (34)
Dr. Teri Stokes has been an Author, Consultant, and Industry Speaker on the topic of computer systems validation for more than 20 years. Her practice includes FDA-regulated industries and their software systems suppliers in Europe, North America, and Asia.