Learn what you need to know to bring Computer Software Assurance to your organization
Kneat’s Computer System Validation (CSV) expert Darren Geaney outlines an easy-to-follow five step process to get your organization CSA ready so you can start validating faster, protecting quality better, and working smarter.
What’s Inside?
- Learn how to prime your organization for the CSA evolution
- Discover what makes CSA different from CSV and what that means for you
- Identify CSV pitfalls are and how to avoid them
- Find out how you can do more by doing less
About the Author
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).