Qualification & Validation

Highly qualified staff able to:

  • Draw up Validation Master Plans, Commissioning Plans and Qualification Plans.
  • Perform Impact Assessments (SLIA,CAs/CDEs)
  • Perform Risk Analyses, for GxP, regulatory and H&S risks
  • Perform Root Cause Analyses (FMEA, Fishbone…)
  • Perform Cleaning Validation.
  • Write/review SOPs and Training support.
  • Training Courses.
  • Write Maintenance Assessments.
  • Review qualification documentation.

Validation activities

  • Instrument calibration and metrology.
  • Writing/performance of:
    • Design Qualification (DQ),
    • Installation Qualification (IQ),
    • OperationQualification (OQ),
    • Performance Qualification (PQ)

for equipment, HVAC/utilities and process plants, Computer System Validation (CSV) for computerised systems.

Global Services for:

  • Routine Calibrations and Qualifications, with fully independent management of the plants, instruments and equipment throughout the facility (production, QC and QA laboratories, warehouses, etc…). A service which reaches from job order management to planning and coordination and the performance of tests on the ground, providing specialised assistance also in case of failures, through to the filing of paper or digital reports.
  • Calibration Management, a service which manages our customers’ instruments, providing routine and extraordinary maintenance, and certification by notified bodies (Accredia or equivalent) from shipment through to certificate management, also providing service in the event of nonconformities.