By James Jardine, MasterControl
Commercial off-the-shelf (COTS) software has dramatically enhanced medical device manufacturers’ ability to accelerate production, integrate processes, and manage quality effectively. Without straightforward guidance from regulators like the U.S. Food and Drug Administration (FDA), however, validation can be so overwhelming, impractical, and time consuming that it actually impedes progress. And when it comes to general guidance for validating commercial off-the-shelf software, FDA directives are nearly 20 years old.
Until an official CSA guidance is issued, medical device manufacturers are largely sticking to traditional methods of COTS software validation that have been cobbled together from various 21 CFR regulations. This approach s evolving to a more meaningful and effective form of validation that is far more efficient, and we owe that to technological innovations and the increasing regulatory emphasis on risk.
Just as device manufacturers are always looking for ways to reduce validation burdens, software vendors are continually looking for ways to help their clients accelerate validation processes. By leveraging the validation work vendors have already performed, device companies can focus their testing efforts on the features of the COTS software they implement that are most critical to their business practices.