When I served in the military there was a term used that is still pretty familiar today: “sound general quarters!” When this order was issued, everyone instinctively stopped what they were doing and manned whatever station was theirs during that time. All commands during general quarters came from the war room behind the bridge of the vessel. Continue reading
Compliance audits present their own orientation to an organization that wants to present the perfect front while being asked to air their dirty laundry. Is this inspection about smoke and mirrors or does the audited facility present a ‘zipped-tight’ posture toward the investigator? Continue reading
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