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Dec, Sat, 2024
The Importance of Electronic Records in 21 CFR Part 11 Compliance
In industries regulated by the U.S. Food and Drug Administration (FDA), such as pharmaceuticals, biotechnology, and medical devices, the management of electronic records is a crucial aspect of ensuring compliance with 21 CFR Part 11. This regulation governs the use of electronic records and signatures, ensuring that they have the same legal standing as paper-based records while maintaining the integrity and security of the data. This article explores the role of electronic records in 21 CFR Part 11 compliance, the regulatory requirements, and best practices for organizations to ensure their electronic records are secure, accurate, and trustworthy.
What are Electronic Records?
Electronic records are any records that are created, modified, maintained, archived, retrieved, or transmitted in electronic form. These records can include various types of data such as:
- Laboratory results
- Clinical trial data
- Manufacturing records
- Quality control documentation
- Regulatory submission data
Under 21 CFR Part 11 compliance, electronic records have the same legal status as paper records, provided they meet specific criteria for authenticity, integrity, and security.