Customized support
- Guiding documents: VMP, commissioning plan, risk analysis
- Participation in URS and specifications
- Regulatory design review
- Traceability matrix and test plans
- Management of the FAT / SAT commissioning stages
- Writing and performing QC / IQ / OQ / PQ tests
- Process validation, cleaning and analytical methods
- Deviation management, evaluation of change requests
- Maintenance of the qualified state
- Audit and training
Accompaniment from the creation to the production stages
- Process equipment
- Pharmaceutical fluids: UPR, EPPI, ACP, VP, pure gases
- Classified premises, HVAC
- PSM, Light flow hood, Isolator
- Cleaning and heat treatment: CIP / SIP, washing machines and cabins, autoclaves
- Packaging line
- Control and supervision systems
Regulatory control and guidelines
- BPF
- cGMP
- GAMP and other ISPE guidelines
- ASPEC
