Commissioning- Qualification
- Validation
First-class service for over 20 years
We handle requests with expertise, ensuring that your experience is smooth and hassle-free. We are reliable partners. We actively collaborate with our clients to understand their specific needs and offer customized solutions. Our flexibility and willingness to adapt to customer demands is what makes us an excellence in our industry
- 1 ITALY OFFICE
- 1 SUBSIDIARY SWITZERLAND
- 1 SUBSIDIARY USA
We offer Commissioning, Qualification and Validation consulting and services.
Specialized consulting for Commissioning, Qualification and Validation activities for machinery,equipment, control and automation systems, factory management information systems, utilities,controlled contamination environments for sterile manufacturing.
Monitoring activities of contamination-controlled rooms, calibration of critical instrumentation, consulting on risk analysis and standard operating procedures of the pharmaceutical industry, in accordance with the requirements of the regulations governing activities in production facilities. Rental of instruments for qualification and calibration.
Engineering
- User Requirements Definition (URS)
- Auditing and technical consulting on plants, processes, equipment
- Design review services (value engineering, GMP review)
- Translation of manuals and technical documentation
Consulting and Management
- Project Management
- Specialized technical consulting
- Plant troubleshooting
- Maintenance and calibration planning
- Supplier audits
- Energy audits
Commissioning Qualification and Validation
- Preparation of Validation Master Plan
- Execution of Design Qualification (DQ)
- Performing risk analysis on systems, processes and equipment
- Coordination and execution of supplier (FAT) testing of systems, equipment, and facilities
- Assisting with start-up of plant, machinery, services
- Commissioning of plant, machinery, services
- Coordination and execution of on-site testing (SAT) of equipment and facilities
- Calibration of instrumentation
- Qualification activities (IQ, OQ, PQ) of equipment and systems
- Periodic requalification and verification activities
- Process Validation Support
Sectors and Specializations
- Bulk process plants
- Cold chain
- "Fill-finish" processing lines
- Air-conditioning systems (HVAC)
- Packaging technologies
- Critical utilities (PW, WFI, CS, etc.)
Work with us
Our company is always looking for qualified staff.
If you are an ambitious professional and would like to join a dynamic and success-oriented team, apply for one of the open positions
Contact us
If you would like to receive more information about our services, if you have any questions or requests, please fill out the form