Creating, Staffing And Managing An Inspection War Room
By Walt Murray, Director of Quality and Compliance Services, MasterControl Inc.
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.
Many companies in the life science sector hear their own version of "sound general quarters!" from FDA and anxiously await the ultimate examination: An inspection visit by the FDA. One of the key components of hosting such an inspection is the preparation and use of a "war room" during the visit. It can be referred to as the primary line of defense in the success of such a visit.
This strategic office should be devoted and organized to provide the necessary objective evidence requested during such an inspection. One of the key observations the inspector will make is the timeliness of the turnaround of a request. A speedy response is always favorably acknowledged and a well-organized war room makes that possible.