We support our clients with efficient commissioning, qualification and validation activities and ensure a punctual system handover for a successful start-up.
Our experienced process engineers guide our clients through the entire commissioning and qualification process for equipment, systems and rooms. Furthermore, they support you in the preparation and implementation of computer system validation as well as cleaning and process validation.
Targeted quality management of course complies with all relevant guidelines and legal requirements (e.g. cGMP / ICH / 21 CFR / ISO / SHE/ASTM).
- Project quality management / document controlling
- Conceptual work for CQV processes
- Preparation of qualification and validation master plans
- Preparation of C&QV documentation (e.g. risk analyses, plans, test specifications, reports)
- Accompaniment of FATs/SATs, commissioning
- Execution of qualifications and validations (equipment / plants, cleaning, manufacturing process, computer systems)
- Creation of as-built documentations
- Plant and equipment qualifications