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 Home  Services Overview  Compliance  Facilities Commissioning
OVERVIEW

Xyntek with hands on experience in the commissioning efforts at several companies is equipped to provide guidance and support for Commissioning activities of regulated research facilities that need to comply with Animal Welfare Act; regulations (9 CFR, Parts 1 , 2 & 3), Association for Assessment and Accreditation of Laboratory Animal Care  (AAALAC) and GxP regulations put forth by the FDA. Commissioning of such a regulated building facility is a complex process of documentation, testing, verification, quality inspection and training that occurs throughout the design, construction, startup and testing operations. Xyntek’s experienced commissioning consultants provide facilities commissioning services for a variety of laboratory facilities including university, research and development, biomedical, pharmaceutical, and industrial research.

METHODOLOGY

Xyntek’s professionals adopt the proven Project Management, Software Development Life Cycle (SDLC), and Validation process and work hand in hand with the facility personnel to employ good planning and risk-based project management to achieve institutional goals, meet user needs, build in flexibility wherever possible to accommodate future expansion, avoid common pitfalls and ensure that the facility is in compliance with the construction contract, including adherence to compliance regulations. Xyntek follows a three-phased approach consisting of Requirements Phase, Document Development Phase and Project Implementation & Commissioning Execution phase, to manage all aspects of the facilities commissioning to ensure things are done right the first time itself.
CASE STUDY
Commissioning/Qualification/Validation Services - Relocation of Laboratories
Xyntek supplied guidance and support for the Commissioning, Qualification, and Validation (C/Q/V) for the relocation of laboratories for one of the top three pharmaceutical companies. A Validation Master Plan was developed to guide all related activities, and ensure compliance with GLP regulations and AAALAC (Association for the Assessment and Accreditation for Laboratory Animal Care) requirements. All necessary documents were developed including, validation master plan, commissioning protocols and qualification plans, master schedule, test summary report, and training documentation.

 

CONTACT US
For more information on Xyntek's Facilities Commissioning Service experience or to find out how Xyntek can help you to realize a solution for your unique Facility Commissioning requirement(s), please contact us here.