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Abstract

Given the major public health importance of medical product safety, it has never been more critical for companies to ensure that their processes and procedures for performing premarketing clinical safety and postmarketing vigilance are in compliance with regulatory requirements and foster the ongoing accumulation of high-quality data. The evolving global environment for medical product safety necessitates that companies look beyond strictly local (ie, national) regulatory requirements to meet the demands of the new international paradigm. Utilizing a proactive approach that entails ongoing auditing of safety-related processes and procedures for effectiveness and compliance with appropriate remediation, medical product safety departments can be better prepared for regulatory agency inspections while maximizing their contribution to company vigilance/risk management efforts.

Examining results of safety-related audits executed internationally provides insight into deficiencies that are common across companies and medical product categories, while offering lessons learned of global applicability.

Keywords

Standard operating procedures (SOPs)Auditing Safety Pharmacovigilance Compliance

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Auditing Safety-Related Processes and Procedures: Lessons Learned for Global Compliance and Quality

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