Commissioning | Qualification| Solutions>
Innovative solutions for pharmaceutical industry, engineering companies and subsuppliers
- Project management for Biotech and Pharmaceutical projects, e.g. for fermenters/bioreactors, equipment, clean rooms and automated systems
- Engineering support (Conceptual Design, Basic Design, Details Design) for fermenters/bioreactors and Clean Utilities for new equipment or retrofits
FAT / SAT
- Strategic Planning and Coordination of FAT / SAT
- Review of User Requirement Specifications (URS) and subsupplier’s documentation
- Preparation of FAT / SAT documents and FAT/SAT execution
IQ / OQ
- Strategic Planning and Coordination of Installation Qualification and Operation Qualification (IQ / OQ) and/or Integrated Commissioning and Qualification
- Preparation and/or review of User Requirement Specifications (URS)
- Validation Master Plans and Validation Project Plans (VMP / VPP)
- Preparation of Traceability Matrices (TRM)
- Preparation of IQ / OQ documents and IQ / OQ execution
- Development of individual concepts for optimization of operational sequences and modification to current GMP standards.
- Project specific trainings for current GMP standards.