Document Control Hot Spots – What Manufacturers Can Do To Avoid Them
This article was originally published in The Silver Sheet
Executive Summary
Document control violations, noted in nearly a quarter of FDA warning letters in 2013, typically occur when manufacturers don’t have procedures or fail to ensure that document changes are applied systemically, FDA says. “When we list document control as an observation on FDA-483 [inspection] forms and cite it in warning letters, usually it’s because the firms don’t have anything at all – no document control procedures – or their document control procedures are inadequate,” CDRH Lead Consumer Safety Officer Ernest Smith notes. Experts also advise firms to schedule periodic document reviews and have a centralized document control group. “Don’t assume that everyone knows about document control,” says Karen St. Onge, a QA official at NxStage Medical.