MasterControl Inc., software provider for FDA-regulated companies, introduces its MasterControl Transfer Operational Qualification (TOQ) to ease the burden of computer software validation. FDA-regulated companies with automated quality management systems are required to provide documented evidence that their systems consistently produce results meeting predetermined specifications, a practice known as validation. TOQ reduces the cost and pain of validation.
Computer software validation involves a series of tests: IQ (installation qualification), OQ, and PQ (performance qualification). For many companies, validation is expensive and challenging because of the extensive time involved, typically several months, along with the specialized skills. The FDA also requires companies to be in a constant state of validation, which generally means they must re-validate every time they upgrade or change their systems.
MasterControl TOQ provides completed validation and support documentation of IQ/OQ tests performed at MasterControl. This documentation serves as evidence that basic functions of a MasterControl application perform correctly against specifications.
With MasterControl TOQ, customers can:
- Reduce validation time, thereby reducing the probability of project failure due to prolonged implementation time;
- Reduce overall validation cost;
- Allocate more validation focus on PQ testing, which is tailored to test the customer's intended uses; and
- Simplify requalification testing, which allows customers to more frequently install upgrades that provide enhanced functionality and address technical problems.