Quality Management White Paper

Transitioning from Computer Systems Validation to Computer Systems Assurance: Factors Life Science organizations need to Consider

The FDA’s Case for Quality launched in 2011 stated that the initiative was set up to promote implementation of critical-to-quality practices during device design and production.

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What is Computer Systems Validation?

Computerized system validation is the process of testing/validating/qualifying a regulated computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper records.

What is Computer Systems Assurance?

Computer Systems Assurance entails performing various levels of validation testing based on the software’s risk.  Computer Software Assurance (CSA) is a Case for Quality initiative that arose when computer systems validation was identified as a barrier to adopting technology for modernization and innovation. The FDA recognizes the value of using advanced technologies to enable the industry to make medicines of more reliable quality.

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