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MasterControl Introduces New Product to Help Ease Validation Burden of FDA-Regulated Companies
SALT LAKE CITY Oct. 6, 2006 MasterControl Inc., the leading software provider for FDA-regulated companies, today introduced a new product that will help life sciences firms dramatically 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.
MasterControl Transfer Operational Qualification™ (TOQ) was especially developed for companies looking to reduce the cost and pain of validation. Based on a company's corporate policy and risk assessment, it may choose to assimilate or "transfer" OQ documentation as part of its overall validation effort, saving both time and money.
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:
MasterControl Transfer OQ is a key part of MasterControl's "continuous" validation approach, which is meant to make software validation faster, easier, and more cost-effective. Under this strategy, MasterControl offers a line of products and services addressing different validation needs based on individual risk assessment.