Validating Software Systems to Comply with CGMP and 21 CFR Part 11 Regulations

November 15, 2019
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FDA Inspections of Clinical Investigators: Are You Ready?
FDA Inspections of Clinical Investigators: Are You Ready?

In the United States, the Food and Drug Administration (FDA) has a number of guidances that are meant to st...

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11 Free Resources to Boost Your Medical Device FDA Readiness
11 Free Resources to Boost Your Medical Device FDA Readiness

This FDA Readiness Toolkit is designed to help medical device manufacturers simplify compliance with FDA st...