News

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:

• Dramatically reduce validation time, thereby reducing the probability of project failure due to prolonged implementation time.
• Dramatically reduce overall validation cost.
• Allocate more validation focus on PQ testing, which is tailored to test the customer's more unique intended uses.
• Simplify requalification testing, which allows customers to more frequently install upgrades that provide enhanced functionality and address technical problems.

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.

About MasterControl
MasterControl Inc. has been at the forefront of providing innovative electronic quality management systems since 1993. Hundreds of companies worldwide use MasterControl to help ensure compliance with FDA regulations such as 21 CFR Parts 11, 210-211, 820, 606; ISO 9000, ISO 13485, ISO 14000, and other ISO standards; and Sarbanes-Oxley Act requirements. In addition to providing off-the-shelf products, MasterControl also offers comprehensive technical and customer support, including product training, implementation, and validation services. For more information, visit www.mastercontrol.com, or call 800-825-9117.