Commissioning, Qualification & Validation (FAT/SAT, IQ/OQ/PQ)

Goal: Complete, consistent qualification packages that stand up to audits.

Support includes:

  • Qualification strategy aligned with the client QMS (risk-based, practical)


  • Writing and leading FAT/SAT protocols and execution


  • Writing and leading IQ/OQ/PQ protocols, execution support, and final reports


  • Requirements/spec alignment where applicable (URS / specs / traceability)


  • Coordination across Engineering, Production, Quality and Suppliers

Contact

Share an audit date, inspection scope, deviation/CAPA situation, supplier issue, or qualification/validation project. Pharmlancer will respond with a suggested approach and next steps.

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