Commissioning, Validation & Qualification

 

Pharma and Life Science projects are conducted according to common GMP guidelines. We take over all qualification activities within the projects. The implementation of pure qualification projects or activities is also one of our strengths.

 

Core Areas

 

  • Quality strategy / validation plan
  • Qualification plans (IQ / OQ / PQ)
  • Quality Need Assessment
  • Documentation
  • Requirements and specifications (URS/FS)
  • Execution
  • Functional Risk Assessment
  • PQM role and Cooperation with QC, QA, Compliance