Software facilitates validation of control systems.
December 10, 2007 -
Complementing TruBio(TM) operating system, TruBio(TM) IOQ package provides all protocols needed to validate maximum process configuration of specific bioreactor type. By choosing relevant sections and following pre-written test procedures, end users can complete installation and operational qualification. 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.
SANTA CLARA, Calif., Dec. 4 /-- Finesse Solutions, LLC, Santa Clara, CA, a manufacturer of measurement and control solutions for life sciences process applications, announced the general release of its TruBio(TM) IOQ package. TruBio(TM) IOQ is designed to take the guesswork out of validation and to complement the fully configurable TruBio(TM) operating system (TruBio(TM) 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(TM) 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(TM) 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(TM) IOQ, customers can quickly validate TruBio(TM) OS functionality, minimize down time and improve predictability of the installation schedule.
Upon completing TruBio(TM) IOQ, users will establish documented evidence assuring that TruBio(TM) OS meets all user requirements and design specifications. TruBio(TM) IOQ provides objective evidence that TruBio(TM) OS performs consistently and accurately per its intended use in the bioprocess application. TruBio(TM) IOQ follows and incorporates established GAMP4 guidelines to ensure that TruBio(TM) OS is compliant with FDA's Title 21 Code of Federal Regulations Parts 11, 210 and 211. TruBio(TM) IOQ also ensures that the TruBio(TM) OS will function as specified in cGMP and cGLP environments.
"The days of long and expensive validation are over. TruBio(TM) IOQ will streamline Installation and Operational Qualifications and at the same time be affordable!" says Yeng Vang, validation manager at Finesse.
About Finesse
California based Finesse leads the way in developing new measurement and control technologies, in order to enable the transition to single-use systems, bring new capabilities to existing bioreactor platforms, and harmonize global bio-process information transfer. Our current product family provides comprehensive measurement and control solutions for upstream processes in the biotech and pharmaceutical industries. For more information, please visit us at http://www.finesse.com/
CONTACT: Kimberly Lozada of Finesse Solutions, LLC, +1-408-327-6613
General Information:
Kimberly Lozada
USA
Phone: 408-327-6613 Company Information: Name: Finesse Solutions, LLC Address: 3350 Scott Blvd, Bldg 1 City: Santa Clara, State: CA ZIP: 95054 Country: USA Phone: 800-598-9515 http://www.finesse.com/
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