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Maria C. Gentile

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Expert view: Tools for compliance with 21 CFR Part 11

All computer systems that store data to make Quality decisions…

11 September 2018 | By

All computer systems that store data to make Quality decisions or data that will be reported to the FDA must be compliant with 21 CFR Part 11. The purpose of this law is to define the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent…