Understanding 21 CFR Part 11 – Electronic Records and Electronic Signatures

By Deb Bartel, 17th April 2018

Life Sciences companies that want to sell their products or services in the United States must comply with the 21 CFR Part 11, Electronic Records and Electronic Signatures regulation. This includes systems used in researching, manufacturing, and distributing product such as pharmaceuticals, medical devices, biological products (e.g. vaccines), blood, and tissue (e.g. organ transplants). It is critical that the professionals who  … Read more

Are you ready for the new version of ICH E6 Good Clinical Practice for Electronic Records?

By Deb Bartel, 16th July 2010

R2 of E6 Good Clinical Practice has been published for consultation. Once approved, it will replace the original R1 version of E6. What’s included in this revision: E6 R2 contains updates intended to increase clinical trial quality and efficiency.  The objective of this draft ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, and the United  … Read more