Juggling compliance with 21 CFR Part 11 and Annex 11?

In this whitepaper we show you how to approach compliance with bothWhitepaper---Approaching-Compliance-with-21-CFR-Part-11--Annex-11_1 directives, as well as how using GAMP 5 can level the playing field

Over the last few decades, technology and computerized systems have changed the way of doing business.  This has been necessary in order 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. 

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.

 Our 21 CFR Part 11 vs Annex 11 Whitepaper includes the following sections: 

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


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