MasterControl officials are touting cloud-based software-as-a-service as a way for medical device manufacturers to speed up validation processes. Their first validation excellence tool (VxT) involves risk-based software validation.
The VxT — which MasterControl (Salt Lake City) showed off last week at MD&M West in Anaheim, Calif. — is a value-add on top of MasterCloud’s software solutions. It is meant to help device makers more quickly meet FDA mandates that require validation of software used for designing, manufacturing, packaging, labeling, storing and more of medical devices. MasterControl boasts that the VxT can cut the validation time from months down to days our hours because its risk-evaluation tool focuses on the critical business processes that need to be documented.
Companies still need to write their own protocols into their own risk profile, but the VxT then guides them on the needed documentation.
“The validation process can be an arduous, tedious, expensive and time-consuming practice that can take several months to complete,” MasterControl CEO Jonathan Beckstrand said in a news release.
“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 that they think would need to be validated,” Beckstrand said. “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.”
For now, MasterControl marketing VxT for software validation, but it could be used for other types of validation in the future, W.E. “Walt” Murray, a consultant for MasterControl, said during a Medical Design & Outsourcing interview at MD&M West.
“It can outside of the traditional software side of it and be used in process validation, used in cleaning validation, used in product validation,” Murray said.
VxT is unique because it can cut across validation needs and limit the tunnel vision that can sometimes hinder a product development process. “It allows for a broader base of validation and strategy because you can have documentation that cuts across all validation needs.”
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