Traditional validation of control systems can be expensive and time consuming, especially when new documents are created by external validation service contractors. Finesse has completed extensive internal validation which we leverage to significantly reduce the amount of testing a customer need complete. Per the GAMP5 classifications, TruBio is considered to be a Category 4 COTS product. With the purchase of the Finesse Validation Package (FAT, SAT, and IOQ), the configurable portion of the software completes validation. The TruBio® IOQ package provides all of the protocols needed to validate the end user configuration: simply follow the pre-written test procedures in order to complete installation qualification (IQ) and operational qualification (OQ).
The TruBio® Validation Package (FAT, SAT, and IOQ) simplifies validation and allows users to establish documented evidence that a Finesse system meets all requirements and design specifications for cGMP and cGLP environments. TruBio Validation Package is written only for the Emerson DeltaV control platform at this time. The TruBio Validation Package enables the customer to use the Family Approach: Finesse provides complete FAT and SAT packages for each hardware configuration. A FAT and SAT are executed on each vessel while the IOQ is executed for a system type. This streamlines the process of validation even further, should the customer elect to use this path.
Upon completing the TruBio Validation Package, users will establish documented evidence assuring that their SmartController and TruBio software meets the expected functional requirements and design specifications, per their intended use case. TruBio IOQ follows and incorporates established GAMP5 guidelines and ensures that the TruBio software will function as specified in cGMP and cGLP environments.