Features

TruMigrations™

TruMigrations have been developed to harmonize and upgrade the installed base of older, proprietary bioreactor control systems. A TruMigration occurs when it is determined that an existing bioreactor control system is no longer able to meet the demands of the process.

TruMigrations seek to provide a cost-effective, easy-to-implement solution, wherein the user can retain existing process hardware, yet overlay the capability and features of TruBio™ software with the reliability and power of DeltaV-based control.

Features

TruBio™ IOQ

Finesse takes the guesswork out of validation by offering TruBio IOQ to complement its open, fully configurable TruBio operating system (TruBio OS). Upon completing TruBio IOQ, users will establish documented evidence assuring that TruBio OS meets all user requirements and design specifications. TruBio IOQ provides objective evidence that TruBio OS performs consistently and accurately per its intended use and user needs.

TruBio IOQ follows and incorporates established GAMP4 guidelines to ensure that TruBio OS is compliant with FDA’s Title 21 Code of Federal Regulations Parts 11, 210 and 211. TruBio™ IOQ also ensures that the TruBio OS will function as specified in cGMP and cGLP environments.