Juggling compliance with 21 CFR Part 11 and Annex 11?

In this guide, we show you how to approach compliance around computerized systems using both directives, as well as how using GAMP 5 can level the playing field.

Over the last few decades, technology and computerized Whitepaper---Approaching-Compliance-with-21-CFR-Part-11--Annex-11_1systems have changed the way of doing business and are almost a requirement to stay competitive in the market. 

However, in the life sciences industry, this transition is accompanied with an additional expectation of compliance with various regulations and guidance like the FDA's Part 11 and Eudralex Annex 11. 

Regulatory bodies across the globe have acknowledged the importance of controlled use of computerized systems and electronic records within the life sciences, and have responded with the enactment of relevant rules and guidelines. All share the common intent of ensuring the integrity of electronic data and records for better patient therapies.

The guide includes the following sections: 

  • What is 21 CFR Part 11
  • What is Annex 11
  • Where do Part 11 & Annex 11 intersect? [+ Detailed Table] 
  • Where are Part 11 & Annex 11 different? and Why? [+ Detailed Table]
  • Three Steps to Achieving Compliance with 21 CFR Part 11 & Annex 11
  • Free Mapping: Annex 11 to Part 11 & GAMP 5 [+ Detailed Table]