Life Science

Commissioning Qualification & Validation

Our teams are involved in setting up rigorous processes to qualify equipment and validate manufacturing processes. Our goal is to ensure compliance with GxP standards, maintain the quality of installations, and minimize the risks associated with failures to ensure product integrity.

Our expertise in equipment qualification ensures reliable and efficient installations, reinforcing the quality of your manufacturing processes and ensuring compliance with current standards.

 

Qualification of equipment or utilities

  • Risk analysis (AMDEC, FMEA)
  • Qualification IQ/OQ/PQ
  • Writing and execution of protocols
  • Writing reports

 

Validation Support:

  • Validation of production processes
  • Cleaning and sterilization validation (CIP/SIP/COP)
  • Computerized systems validation (CSV)