QUALITY REPLAY: Walking The Document Control Tightrope – How Manufacturers Can Toe The Line
From our digital archives: Document control violations typically occur when manufacturers don’t have procedures or fail to ensure that document changes are applied systemically, FDA says. 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.
Register for our free email digests: