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Compliance

- PRIMECO Srl

GMP & Compliance

  • FMEA
  • SOP's
  • Computer System Validation (GAMP V)
  • Risk/Compliance assessment
  • Supplier auditing
  • Validation plan & Qualification summary report
  • IQ/OQ protocols
  • Final reports

Certification and field testing

Certification and field testing - PRIMECO Srl
  • HVAC testing
  • Cleanroom monitoring
  • Particle / microbial ISO/EU-GMP class
  • Recovery time
  • Differential pressure
  • HEPA filter leak testing
  • Thermal mapping

Instrument calibration

Instrument calibration - PRIMECO Srl
  • On-site calibration
  • Calibration planning and follow-up
  • ISO21501 calibration
  • Definition of acceptance criteria
  • Definition of tolerances

Compliance

Compliance - PRIMECO Srl

Engineering

Engineering - PRIMECO Srl