How To Keep Compliance With Title 21 CFR Part 11 And EU GMP Annex 11

Two crucial regulatory guidelines that describe the proper use of computerized systems to perform GMP-related activities are the Food and Drug Administration’s Title 21 CFR Part 11 and the EU GMP “Annex 11: Computerized Systems” published by the European Commission as part of EudraLex. This white paper analyses the requirements of Part 11 and Annex 11 as they apply to environmental monitoring and validation, and outlines how Vaisala’s Continuous Monitoring System software viewLinc helps firms meet the requirements of both.