The U.S. Food and Drug Administration (FDA) established 21 CFR Part 11 to set the criteria for electronic records and electronic signatures, ensuring they hold the same level of integrity and trustworthiness as traditional paper records and handwritten signatures. This regulation is essential for companies in the life sciences sector, including pharmaceuticals, medical devices, and biological products, which are required to comply with FDA regulations to operate within the United States.

21 CFR Part 11 provides a framework that allows companies to transition from paper-based systems to digital records while maintaining compliance with FDA standards. The regulation covers a wide range of aspects, including system validation, record retention, audit trails, and access controls, ensuring that electronic records are accurate, reliable, and secure.

This executive summary explores the comprehensive approach of Good Automated Manufacturing Practice (GAMP) to achieving compliance with 21 CFR Part 11. It details the historical context, objectives, key components, benefits, challenges, and the role of risk management in ensuring compliance with the regulation.

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