FDA Final Part 11 Scope and Application Guidance

FDA CDER issued a final guidance for Part 11 as part of its redirection effort for electronic records and signatures expectation. This is available at the link provided. This guidance is generally consistent with the earlier draft guidance. It also states explicitly that FDA is planning to revise the regulation itself and it explicitly states word processors used to generate SOPs do not require validation.

Latest News!

Updated Risk Management training course now available.  Includes:

  • Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.  Contact training@softwarecpr.com

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.