Solutions and technical support for the FDA regulated industry

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SERVICES

COMMISSIONING AND QUALIFICATION

Our Commissioning and Qualification services ensure that your bio pharma facilities, utilities, and equipment meet regulatory requirements and perform as intended.

We meticulously plan and execute commissioning activities to verify that systems are installed correctly and function properly. Through qualification protocols and testing, we validate the performance of equipment and processes, ensuring reliability, consistency, and compliance with industry standards. Our expert team collaborates with you to navigate complex regulatory landscapes, mitigate risks, and optimize operations, ultimately delivering safe and efficient bio pharma facilities and processes.

  • Manufacturing and Packaging Equipment Qualification (IQ, OQ, PQ)
  • Design Qualification
  • Maintenance System Qualification
  • Utilities Qualification
  • Facilities Qualifications
  • FAT / SAT
  • HVAC Qualification
  • Risk Assesment
  • Risk Management: Direct vs Non-Direct Impact; Critical vs Non-Critical
  • Commissioning and Enhanced Commissioning
  • Decommissioning
  • Integrated Validation Approach
  • Instrumentation
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