111 ANNEX11 COMPUTERISEDSYSTEMS Principle Theintroductionofcomputerisedsystemsintosystemsofmanufacturing,including storage,distributionandqualitycontroldoesnotaltertheneedtoobservetherelevant principlesgivenelsewhereintheGuide.Whereacomputerisedsystemreplacesamanual operation,thereshouldbenoresultantdecreaseinproductqualityor...
The FDA’s 21 CFR Part 11 and the EU’s EudraLex Volume 4 Annex 11 outline standards for electronic records and signatures in GMP-regulated industries. These regulations ensure that electronic documentation is as reliable and secure as paper-based systems, facilitatin...