GxP and 21 CFR Part 11 Compliance Management Software

Generic Drug and API Manufacturers recognize that by going paperless they will need to be 21 CFR Part 11 and Annex 11 compliant in all areas: IT infrastructure, SOPs, software product features and so on. The benefits of an electronic system are an immediate improvement in productivity and a significantly lower risk of 483 Warning Letters or non-conformances.

In using the QUMAS Compliance Platform, Organizations can be confident that they are complying with CFR Part 11 as well as Annex 11 in completing Electronic Signatures and utilizing a fully compliant electronic audit trail that supports point in time reporting.