Understanding 21 CFR Part 11

by | Mar 11, 2024 | Compliance, FDA, Medical Devices, MedTech, Regulatory

For pharmaceuticals, biotechnology, and medical devices, regulatory compliance is a cornerstone of ensuring product quality, safety, and efficacy. Among the myriad regulations governing these industries, 21 CFR Part 11 stands out as a critical standard for electronic records and electronic signatures. This blog will give an overview of what 21 CFR Part 11 entails and its implications for regulated companies.

21 CFR Part 11 is a regulation issued by the FDA that establishes requirements for the use of electronic records and electronic signatures in FDA-regulated industries. Enacted in 1997, Part 11 was designed to ensure the reliability, authenticity, and integrity of electronic records and signatures used in lieu of traditional paper-based documentation.

Key Components of 21 CFR Part 11 include:

  • Scope and Applicability: Part 11 applies to electronic records and signatures that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in FDA regulations. This includes a wide range of activities and processes within pharmaceutical, biotech, and medical device companies, such as clinical trials, manufacturing, quality control, and distribution.
  • Requirements for Electronic Records: Part 11 outlines specific requirements for electronic records, including provisions related to validation, access controls, audit trails, and data integrity. Electronic records must be accurate, reliable, and secure throughout their lifecycle, from creation to disposal.
  • Requirements for Electronic Signatures: Part 11 establishes criteria for the use of electronic signatures, including methods to ensure the authenticity, integrity, and non-repudiation of signatures. Electronic signatures must be unique to the individual, securely linked to the associated record, and protected against unauthorized use.
  • Validation and Compliance: Companies subject to Part 11 are required to implement controls and procedures to ensure compliance with the regulation. This includes validation of electronic systems, documentation of policies and procedures, training of personnel, and periodic review and audit of electronic records and signatures.

Compliance with 21 CFR Part 11 is essential for regulated companies to maintain the integrity and reliability of electronic records and signatures. Non-compliance can result in regulatory enforcement actions, including warning letters, fines, and product recalls, as well as reputational damage and loss of market credibility.

Achieving and maintaining compliance with Part 11 requires a comprehensive approach that encompasses both technical and procedural controls. Regulated companies must invest in electronic systems that meet Part 11 requirements, implement robust data security measures, establish clear policies and procedures for electronic recordkeeping, and provide ongoing training to personnel on compliance requirements.

As technology continues to evolve, so will the regulatory landscape governing electronic records and signatures. The FDA has signaled its intent to modernize and streamline its approach to digital health technologies, including potential updates to Part 11 to reflect advancements in electronic recordkeeping and signature technologies.

In conclusion, 21 CFR Part 11 plays a pivotal role in ensuring the integrity and reliability of electronic records and signatures in FDA-regulated industries. Compliance with Part 11 is not just a regulatory requirement—it’s a fundamental aspect of maintaining product quality, safety, and efficacy in an increasingly digital world. By embracing the principles of Part 11 and implementing robust controls and procedures, regulated companies can navigate the complex terrain of electronic recordkeeping with confidence and integrity.

EMMA International can ensure your system is compliant with 21 CFR Part 11. Call us at 248-987-4497 or email info@emmainternational.com to learn more!FDA (Aug 2018) Part 11, Electronic Records; Electronic Signatures – Scope and Application retrieved from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

EMMA International

EMMA International

EMMA International Consulting Group, Inc. is a global leader in FDA compliance consulting. We focus on quality, regulatory, and compliance services for the Medical Device, Combination Products, and Diagnostics industries.

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