Medical device development

Salt Lake City, Utah – MasterControl Validation Excellence Tool (VxT) enables companies required to conduct risk-based software validation to reduce the time from months down to days or hours. VxT, free with the company’s cloud solutions, leverages a new methodology called MasterControl Validation Excellence (Vx),which combines a best-practice testing and software lifecycle approach with a risk-evaluation tool that focuses on the critical business processes (CBPs) for life science companies.

The FDA mandates that software used for the design, manufacture, packaging, labeling, storage, installation and servicing of all medical devices and pharmaceuticals intended for human use be validated. MasterControl VxT is a cloud application designed to help users assess their validation risks, identify the CBPs that require validation, and minimize the organization’s validation requirements of MasterControl cloud-based systems.

“The validation process can be an arduous, tedious, expensive and time-consuming practice that can take several months to complete,” says Jonathan Beckstrand, CEO of MasterControl. “Companies conducting validation would err on the side of caution and cast a wide net to ensure they cover all aspects of the MasterControl systems they think would need to be validated. With VxT, companies will know exactly what they need to validate based on risk. We collaborated with numerous industry experts, including former FDA officials, who provided critical input in the VxT’s design and testing to ensure it will satisfy FDA and other regulatory bodies’ requirements. There is nothing else on the market like MasterControl VxT.”

The easy-to-use application includes the Comprehensive Risk Assessment and Testing Mitigation tool, which evaluates multiple risks, such as software usage, impact of failure, regulatory requirements, variation from best practices, and testing mitigations.

MasterControl VxT was released with the newest version of the MasterControl software solution, version 2017.2, which includes a number of new features.



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