Achieving Computer Software Assurance (CSA) with Digital Validation

Achieving Computer Software Assurance (CSA) with Digital Validation

The FDA recently released its Draft Guidance for Computer Software Assurance (CSA) for Production and Quality System Software. Join CSV specialist, Darren Geaney, to walk through the changes and what they mean for validating computer systems.

Attend and learn:

• What the FDA’s September 2022 CSA guidance means for validating computer systems
• How CSA reduces documentation burden and issues in Production through unscripted and ad-hoc testing
• How to shift from CSV to CSA through risk-based critical thinking
• How to ‘scale assurance’ by leveraging other activities
• Efficiencies and assurances of performing CSA using a digital validation system [case study]

Presented by:

Darren Geaney, BEng, Kneat

A Computer Systems Validation specialist, 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).