What the Food Safety Modernization Act (FSMA) Means to the Food and Beverage Industry

November 15, 2019
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Annex 11 and 21 CFR Part 11: Comparisons for International Compliance
Annex 11 and 21 CFR Part 11: Comparisons for International Compliance

The two essential resources regarding the validation of computer systems are: the FDA’s 21 CFR Part 11 and ...

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Annex 11: The EU's New Expectations for Regulated Computerized Systems
Annex 11: The EU's New Expectations for Regulated Computerized Systems

This white paper summarizes Annex 11 to clarify the guidelines for when a computerized system replaces a ma...