Finesse Introduces TruBio IOQ
Finesse Solutions releases TruBio IOQ package. TruBio IOQ is designed to take the guesswork out of validation and to complement the fully configurable TruBio operating system (TruBio OS).
Traditional validation of control systems can be expensive and time consuming, especially when new documents are created by external validation service contractors. The TruBio IOQ package provides all of the protocols needed to validate the maximum process configuration of a specific bioreactor type. By simply choosing the relevant sections and following the pre-written test procedures, end users can complete their installation and operational qualification.
Project managers utilizing TruBio IOQ can save valuable project time by eliminating the need to develop validation protocols and by minimizing the validation efforts traditionally found in implementing a new control system. With TruBio IOQ, customers can quickly validate TruBio OS functionality, minimize down time and improve predictability of the installation schedule.
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 in the bioprocess application. 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.
"The days of long and expensive validation are over. TruBio IOQ will streamline Installation and Operational Qualifications and at the same time be affordable!" says Yeng Vang, validation manager at Finesse.