Both the U.S. FDA and EU's MDR expect documented risk-based V&V under U.S. FDA cGMPs, the EU MDR, ICH Q9 and ISO 14971
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in verification and validations. And now the FDA is taking an even tougher stance. One major failing is lack of sufficient or targeted risk-based V&V planning / execution. Consider some basic principles in the FDA's various guidance documents on Validation. A software V&V "model" will be presented. The "must have" elements from ISO 14971( and ICH Q9) for hazard analysis and product / process risk management. Integration of validation essentials into a company's quality management system.
Review a company's Verification and Validation system for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance, and it's most recent Process Validation guidance upgrade (device principles from pharma). One major failing is lack of sufficient or targeted risk-based V&V planning and associated documentation. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management, allows the development of meaningful product quality-specific process validations. Consider Human Factors / Use Engineering elements where required. Also the roles of different V&V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents. Our matrix examples simplify "as-product", in-product, equipment and process software, assuring key FDA requirements are not overlooked. The QSR/QMRS/ISO 13485 and 21 CFR Part 11 and cybersecurity are all considered.
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 42 years’ experience in U.S. FDA-regulated industries, 28 as a full-time consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.
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