FACILITIES / UTILITIES START UP & CQV

We strive to successfully Commission and Qualify Facilities and its Utilities by utilizing our Facility Management expertise to accurately validate designed processes.   We follow U.S. regulation, 21 CFR 211.42 guidelines  for the expected design and construction features.

• MASTER FACILITIES VALIDATION PLAN: As part of the MVP, strategic steps are highlighted based on industry's best practices and site design.

• STRATEGIC VALIDATION: Each of the process Critical-to-Function requirements are listed and then added to a Traceability Matrix to assure completion throughout the process. 

• USER REQUIREMENTS:  We generate the Site User Requirement Specification (URS) and each Utility Equipment as required, based on voice of the customer and product requirements.

• EQUIPMENT DESIGN QUALIFICATION (DQ): In the DQ we clearly state and reach  agreement on the roles and responsibilities in developing the concept together with the A&E firm and generate a list of the  appropriate qualification documentation (a form of Traceability matrix) required for the Facilities and each utility.  Without this step our clients would be led to a facilities design that is "thought" suitable to meet pharmaceutical GMP requirements. 

• EQUIPMENT DESIGN: We work with the Original Equipment manufacturers (OEM) for each listed utility (AHU, Chillers, Air Compressors, Purified Water Skids, Steam Generators Skids, Back Up Electricity Generators, etc) to assure capturing design requirements and their capabilities.

• FACTORY ACCEPTANCE TEST (FAT): We strive to execute FAT documents, when possible, for AHU, Air Compressors etc, to minimized mishaps during on site installation/qualification.

• INSTALLATION / OPERATIONAL QUALIFICATION (IOQ):  We provide expertise during equipment rigging and  installation.  Our team develops all necessary documents, including Work Orders using your Site's QMS and assure work is compliant.  We coordinate each of the system's start ups with the OEM's and have the install certified by their experts prior to IOQ execution.

• PROCESS QUALIFICATION (PQ): We are hands-on during the Technician's Certifications to assure expertise during the PQ execution and proper hand-shake with the site Facilities team(s).

• CLEANROOM CERTIFICATION: We support and manage the cleanroom certification partnering with a qualified agent.  We ensure HEPA filters and Fan Filter Units (FFUs) have a written certification and re-certification schedule.