QUALIFICATION & VALIDATION

Qualification & Validation

• Drafting of documents (e.g.: SOPs, specifications, master plans, risk analyses)
• Creation of DQ/IQ/OQ/PQ protocols, plans and reports
• Execution of qualification and validation tests
• Cleaning validation
• Cleanroom qualification
• Sterilization validation
• Transport validation
• Validation of computerized systems
• Provision of measuring equipment

Calibration

• On-site management of the client’s measuring equipment
• On-site calibration of common physical parameters (temperature, humidity, pressure, CO₂ concentration, additional parameters available on request)

Engineering

• Advice on the commissioning of equipment and systems