21CFR11 Compliance and Automated Manufacturing

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Overview:

21CFR11 took effect in August 1997 with little observed regulatory activity. However, that has changed and increasing numbers of FDA warning letters are being generated for software used for GMP, GCP, or GLP (GxP) purposes. This presentation addresses the impact of 21CFR11 on automated manufacturing systems and processes. Included is an overview of 21CFR11, a discussion of the processes needed to reach compliance including 21CFR11 interpretation, assessment and remediation activities, and some issues for legacy automated manufacturing systems. It will speak to the compliance issues for hybrid systems where there is a multiplicity of options between totally paper based and totally electronic systems.