Context and challenges
This client is a Swiss biotechnology company, that has recently been acquired by an international major biopharmaceutical company. This client wished to increase the production of its flagship product at its plant located in Neuchâtel. For this purpose, this company had to set up a new production line (biotech upstream and downstream process). Therefore, this company needed to shut down the whole facility until the new line was fully operational.
In order to maintain its production capacity, this client needed to reduce the duration of the production shutdown and ensure the proper start-up of the new biotech production line.
This client appointed Assystem Care to get support in the qualification and validation phases for this new production line, applying the ASTM E2500 methodology. Assystem Care has also been appointed to provide a coaching and mentoring program for more than 20 client collaborators (called “Subject Matter Expert”) in order to ensure transfer of skills after implementing the ASTM E2500 methodology.
Apollo Maturity and Atlas solutions are Assystem Care proprietary solutions and project management set of tools with standardised processes and methodologies.
(1) Commissioning, Qualification, Validation; (2) CSV: Computer System Validation; (3) URS: User Requirements Specifications - DR/DQ: Design Review/Design Qualification - FAT: Factory Acceptance Test - SAT: Site Acceptance Test - IV/OV: Installation Verification and Operational Verification - PQ: Performance Qualification; (4) IS/AS: Information Systems/Automated Systems
of duration shutdown
weeks vs 36 weeks