Darren Geaney

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Kneat
Process Engineer and Subject-Matter-Expert on Computer System Validation
Darren Geaney is a Process Engineer and Subject-Matter-Expert on Computer System Validation at Kneat. Darren has over 23 years’ experience in software validation, providing right-sized computer system validation solutions to medical device companies.

Knowledgeable in regulations FDA 21 CFR Part 820, 21 CFR Part 11, ISO 62304 and ISO 14971, Darren is ‘Lead Auditor’ accredited and experienced in supporting both internal and external audits (including FDA, IMB, TUV, and BSI).

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Five Steps to Implementing 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 Kneat guide — authored by CSV expert Darren Geaney — provides a clear and structured roadmap to success in 2025.