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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Understanding Computer Software Assurance (CSA)
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Understanding Computer Software Assurance (CSA)

The FDA recommended CSA seeks to speed Computer System Validation (CSV) without sacrificing quality, but there’s a lot to know before you get started. This eBook, authored by CSV expert Darren Geaney, will give you a foundation of understanding so you can take the first step in your CSA journey with confidence.