Demystifying the process of complying with 21 CFR Part 11

There’s been a lack of clarity around what’s needed to comply with 21 CFR Part 11, the US Food and Drug Administration’s regulations for inspecting electronic training records held by organizations.

Implementing electronic signatures and being able to clearly audit their use has often been a considerable challenge for businesses in the life sciences and pharma sectors.

This is an essential requirement for companies in these sectors looking to comply with the FDA’S CFR regulations. In-depth and rigorous auditing is increasingly sought-after by organizations in other sectors too, such as healthcare.

A photo of a person sitting at a laptop holding a bottle of manufactured pharma drugs as an illustration of the pharma 21 CFR Part 11 regulation

21 CFR Part 11 Electronic Records and Signatures Regulation – 20 Years On

This year is the 20th anniversary of the publication of Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11 or just Part 11), the US Food and Drug Administration (FDA) regulation about control of electronic records and electronic signatures for computerised systems used by pharmaceutical and medical device companies. This is a relatively small regulation (less than 2 complete pages of the Federal Register) that has had and continues to have a big impact on regulated organisations and software suppliers.

When implementing computerised systems, the requirements of Part 11 need to be fully understood. To help this, I want to explore the following areas in this blog post:

  • What is Part 11?
  • Interpretation of Part 11 by the applicable predicate rule
  • Understanding the technical, procedural and administrative controls of the regulation
  • What is software validation?
  • Why do I need to validate my LMS?