As health and life sciences industries continue to shift from paper to digital, CFR 21 Part 11, a regulation issued by the U.S. Food and Drug Administration (FDA), has become a cornerstone of compliant electronic recordkeeping. It defines how organizations must manage electronic records and signatures to ensure they are as trustworthy, reliable, and legally valid as their paper counterparts.
Compliance is essential for any organization using electronic systems in FDA-regulated environments, such as:
- Pharmaceutical and biotech manufacturing
- Clinical trials and R&D
- Laboratory testing
- Medical device development
- Entities submitting data to the FDA
In this webinar, we’ll break down the essentials of CFR 21 Part 11, including:
- What’s driving the rise in compliance demands
- Real-world examples of processes that fall under the regulation
- The strategic benefits of being compliant
- The serious risks of non-compliance
- How third-party audits enhance assurance, and what they assess
Whether you're digitizing operations or scaling compliance programs, this session will equip you with the insight to manage and leverage CFR 21 Part 11 effectively.