MasterControl has again set an industry benchmark by being the first company to deliver a Transfer Performance Qualification (TPQ) solution, which automates a previously cumbersome portion of the software validation process — a requirement for highly regulated companies.
Software validation establishes documented evidence that demonstrates an organization has a high degree of assurance that the software it uses has been installed correctly, will meet its needs and will mitigate risk. Software validation traditionally consists of three areas: Installation Qualification (IQ); Operational Qualification (OQ); and Performance Qualification (PQ).
OQ has traditionally been the most time-consuming of the three tests. MasterControl virtually eliminated that pain with its innovative TOQ product. With that challenge resolved, the PQ became the most laborious validation task. For customers of MasterControl’s cloud-based quality management system (QMS), Spark, the arduous tests and steps involved in the PQ will no longer rest on the shoulders of customers.
“The testing process for PQ can be extremely cumbersome and time consuming, which is particularly challenging for small businesses,” said Matt Lowe, Executive Vice President of MasterControl. “This is the first solution of its kind. Now, MasterControl will conduct all the testing and deliver the proof to satisfy the FDA.”
The key for TPQ is in the “transfer,” meaning MasterControl will conduct all of the testing. This is made possible through the common cloud environment, and by the fact that Spark customers are preconfigured, so any testing performed by MasterControl will match the customer’s actual production environment and configuration. By producing the reports necessary to prove validation and passing along the documentation to customers, MasterControl is saving customers weeks and even months of tedious work.