Facility Commissioning and Validation Services

Our facility validation encompasses a comprehensive suite of services to ensure your facility not only meets but exceeds industry expectations:

• Focused Commissioning: We initiate with a meticulous commissioning phase to verify that all systems and utilities are installed and function in line with precise engineering specifications.

• Calibration Assurance: Our rigorous calibration protocols ensure that all measurement equipment operates with unparalleled accuracy and compliance.

• Equipment Qualification: We conduct thorough qualifications of your equipment to confirm it meets all operational requirements and specifications.

• EMPQ Proficiency: Our Enhanced Model for Process and Product Qualification (EMPQ) capability provides a robust framework that integrates process, equipment, and facility validation, ensuring a holistic approach to your facility’s validation needs.

By integrating these critical components, we deliver a validation service that not only establishes a solid foundation for your operations but also supports your journey through the full lifecycle of your facility's GMP compliance.

Commissioning Test Plans (CTPs) are critical components of our comprehensive approach to facility validation, designed to ensure that your systems and equipment are set up for success right from the start. Here's what they involve:

• Integration with System Acceptance Tests (SATs):

  • Our CTPs augment SATs by evaluating the interplay of various systems within an integrated setting, identifying opportunities for enhanced optimization.

• Inspection and Verification:

  • Confirmation of specified equipment and systems installation accuracy.
  • Verification of proper utilities connection and functionality.
  • Assessment of the human interface for operational ease and safety.
  • Evaluation of safety, environmental, and ergonomic factors.
  • Completion checks for documentation, including user manuals, and ensuring all closeout tasks are finalized.
  • Ensuring that user personnel have received comprehensive training.

• Operational Readiness:

  • Equipment and system performance according to specifications.
  • Fulfillment of User Requirement Specifications (URS), Functional Requirement Specifications (FRS), or Basis of Design (BOD) criteria.
  • Operational safety and the production of safe results.
  • Effective operation within the integrated facility environment.
  • Accuracy and currency of calibration for all pertinent equipment.

For smaller scale projects, we utilize streamlined commissioning checklists to efficiently cover all critical aspects without overcomplicating the process. These checklists are enhanced to ensure:

• Installation accuracy.
• Utility connections.
• Operational functionality.
• Calibration verification.
• Thorough documentation and training completion.
• Entries into the Computerized Maintenance Management System (CMMS).
• Adherence to other internal requirements.

Our CTPs are meticulously tailored to meet the specific needs of each facility, ensuring a solid foundation for successful production and subsequent qualification phases. This strategic approach not only saves time and resources but also instills confidence that your facility will meet all operational expectations with assured compliance.

Yes, our services can be tailored using off-the-shelf templates or custom protocols to fit the unique needs of your facility.

Commissioning is the initial step in the CQV process, confirming that the facility's design and construction align with the intended operational capabilities, without yet considering the direct product impact.

Our services are built around ISPE's guidelines, ensuring industry best practices are met during the commissioning phase. We focus on satisfying engineering requirements and creating a compliant groundwork for production.

Our precision, attention to detail, and commitment to regulatory compliance ensure that your facility is not just built to the highest standards but also prepared to meet the rigorous demands of clinical excellence.