technology

GxP content management

Cloud or on-premises repositories that version, route for approval and retain controlled GMP/GxP documents — SOPs, batch records, validation protocols — with a full 21 CFR Part 11-compliant audit trail.

Where it's used

GMP document management systems
Dedicated repository platforms that version, route for approval and retain controlled GMP documents — SOPs, batch records, validation protocols — as their own connected content layer, distinct from the deviation/CAPA/training hub a broader eQMS runs on top of the same documents.
digital-it 6 min