We support and look after our customers from the pharmaceutical industry in all three cycles of process validation according to FDA:
- Process design during development or engineering
- Process qualification from engineering to operation of the systems
- Continued process verification during manufacture
We offer the following scope of services:
- Creation of user requirements
- Change Control
- Design Qualification (DQ)
- Acceptance test at the supplier (FAT)
- Site acceptance test (SAT)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Validation (prospective, retrospective)
- Qualification
- 21CFR11
- Recipe creation
- SFC
- CFC
- Visualizations
- Integration of package units via all common interfaces
- Documentation (user requirements, specifications, design, operating instructions)
