GxP compliance: electronic records and signatures guide

A collection of quality guidelines and regulations designed to ensure your products and projects are safe, meet their intended use, and adhere to quality processes throughout the manufacturing, control, storage and distribution stages

GxP guidelines represent the minimum requirements your business needs to meet

GxP compliance is essential for life science organizations and any regulated business which supplies products and services to the U.S. and E.U.

Represented through 2 major pieces of legislation:

  • EudraLex Volume 4 Good Manufacturing Practice (Annex 11: Computerised Systems)
  • FDA 21 CFR Part 11 cGMP guidelines FDA 21 CFR Part 11 vs. EU An