Five Steps to Implementing CSA

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).

 

Why Kneat

Proven

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Industry-Leading Validation

Kneat is trusted by 8/10 world’s largest life sciences companies to provide digital validation and GDP solutions across the entire manufacturing lifecycle.

Data Integrity

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Uncompromised Data Protection

We protect data integrity across the entire validation lifecycle with password protected signatures, automatic timestamps, and a comprehensive audit trail.

Efficiency

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Maximized Process Efficiency

Kneat is Proven to reduce validation cycle times by 50% across multiple validation disciplines through online test execution, remote approval, and more.

Trusted

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Seamless Audit Preparation

We set you up for audit success from the start with automatic audit trails and easy paperless handovers  to make it easier for audits and remote inspectors.

Contact

Talk to us

Find out how Kneat can make your validation easier, faster, and smarter.
Start your paperless validation revolution by speaking to our experts.

Europe: +353-61-203826
U.S: +1 888 88 KNEAT
Canada: +1 902 706 9074