A Brief History Of 21 CFR Part 11: Electronic Records And Electronic Signatures

Vivek Gera
Jul 4, 2019 · 2 min read

If you are connected to the life sciences industry in one way or another, you have undoubtedly heard of the USFDA’s 21 CFR Part 11 regulation. It applies to systems used in researching, manufacturing, and distributing products such as pharmaceuticals, medical devices, biological products (e.g. vaccines), blood, and tissue (e.g. organ transplants). FDA gave electronic signatures legal equivalence with traditional “wet ink” signatures on paper in 1997.

History

The infographic below provides a brief history regulation thus formed by the FDA.

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Overview

It must be noted that using Electronic record keeping and electronic signature are not mandatory, but if used must comply with the regulations in 21 CFR part 11.

Let us decode the title “21 CFR Part 11”

  • 21: Short for “Title 21,” which is the section of the CFR that applies to food and drugs. The CFR contains 50 “titles.”
  • CFR: Short for “Code of Federal Regulations,” which is a set of laws published by the federal government of the United States.
  • Part 11: This part of Title 21 is specific to electronic records and electronic signatures, which includes electronic submissions to the FDA.

Requirements Of Part 11

  • Secure retention of electronic records and instant retrieval.
  • User-independent computer generated time-stamped audit trails.
  • System and data security, data integrity and confidentiality through limited authorized access to systems and records.
  • Use of secure electronic signatures for closed and open systems
  • Use of digital signatures for open systems.
  • Use of operational checks.
  • Use of device checks.
  • The determination that the persons who develop, maintain or use electronic systems have the education, training, and experience to perform their assigned task

Implications Of 21 CFR Part 11 For The Industry

However, to utilize these noteworthy benefits, FDA regulated companies must maintain requisite features in their systems, establish Standard Operating Procedures, and perform regular System Validation.

leucine

Bringing Efficiency To Pharma Compliance

Vivek Gera

Written by

leucine

leucine

Bringing Efficiency To Pharma Compliance

Vivek Gera

Written by

leucine

leucine

Bringing Efficiency To Pharma Compliance

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