White Paper: Current Regulatory and Compliance Trends in the Area of Consent Decree in Pharmaceutical, Medical Device and Biologics.
Review current regulatory and Compliance Trends. As we explore top Regulatory Enforcement trends in the area of Consent Decree, we see that key areas of focus and Regulatory Enforcement are: Computer Systems Validation (focusing on 21CFR Part 11, Electronic Records and Signatures (ERES), Equipment Qualification, Change Control Systems, Proper Laboratory Investigations, Corrective Action/Preventative Actions (CAPA), Root Cause Analysis (RCA), etc.
FDA uses Consent Decree to change overall corporate culture in compliance matters by pulling the company out of a pattern of long-standing cGMP problems and raising it to current standards.
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