The U.S. Food and Drug Administration (FDA) is changing its approach to validation. Its 2002 guidance on the subject put great emphasis on risk-based validation. The good news for regulated companies is that this approach means less testing and less documentation.
MasterControl’s patented Validation Excellence Tool (VxT) is our answer to risk- based validation. We worked with former FDA officials and industry experts to develop the tool, which lets you leverage the validation work that MasterControl has already done and focus your testing on the features that are most important to your business practices. Customers that use the VxT find that it significantly reduces their validation time, in some cases to a matter of hours.