Qualification and Validation

Client

• Healthcare facility/Manufacturer of medical compressed air

Client benefits

• Measurements with electrochemical sensors and recordings and archiving of the measurement data mean the customer receives valid statements about their system’s conformity.
• Supplier qualification ensures that the system and the equipment used are suitable in accordance with GMP guidelines.
• The systems and equipment are qualified/validated prospectively using a risk-based approach. This qualification and validation are integral parts of the product life cycle.
• EXCO provides employee training and external company training to ensure skills are transferred.

EXCO Services and the product in the overview

• Requirements specification
• Functional detailed specification
• GMP validation/qualification plans
  GMP risk analysis
• Qualification (DQ, IQ, OQ, PQ)
  Process validation (PV)
• Validation and qualification report
  Traceability matrix
• Supplier qualification
• Accompaniment of FAT and SAT acceptance phases