FDA 21 CFR Part 11, and its sister compliance EU GMP Annex 11, require organizations to implement controls, audit trails, electronic signatures, and documentation for software that processes the electronic data the
FDA requires them to maintain. This commonly applies to organizations producing pharmaceuticals, medical devices, biotech and biologics.
FactoryFour has implemented all the necessary administrative and technical procedures to be compliant, and cover IQ (installation qualification) and OQ (operational qualification). FactoryFour Customer Success can
provide recommendations to your personnel for PQ (performance qualification) required to incorporate FactoryFour into processes covered by Part 11 or GxP.