Darren Geaney

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Kneat
Computer System Validation (CSV) Specialist and Digital Validation Expert
Darren Geaney is a Computer System Validation (CSV) specialist and digital validation expert with over 23 years of experience delivering right-sized validation solutions to pharmaceutical

and medical device companies. His expertise spans software validation, risk management, and regulatory compliance, with in-depth knowledge of FDA 21 CFR Part 820, 21 CFR Part 11, ISO 62304, and ISO 14971. A certified Lead Auditor, Darren has extensive experience supporting both internal and external audits, including those conducted by the FDA, IMB, TÜV, and BSI.

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Five Steps for Implementing Computer Software Assurance (CSA)

By implementing CSA, teams can accelerate software validation, reduce validation cycle times, and enhance compliance while freeing up valuable resources. Whether you are starting your CSA journey or refining existing processes, this guide — authored by CSV expert Darren Geaney — provides a clear and structured roadmap to success in 2025.