Many companies will try to resolve compliance actions by the Food and Drug Administration (FDA) through the use of an electronic document management system (EDMS) approach that is typically post mortem.

This is risky business at two critical levels.  First, no EDMS approach will replace the operation of a comprehensive quality management system (QMS) that describes the integration of necessary GxP (compliance) driven quality processes.  Secondly, the response will need to have a litany of justifications for a retrospective systematic approach.  This is like trying to perform process validation on pre-existing production of unqualified products: it’s bad business! Continue reading →