CSV/data integrity to rebuild the quality...
CSV/data integrity to rebuild the quality systems of a site IS
project
CQV for a new production unit of gene and cell therapy treatments
Compliance Life Sciences France
Context and challenges
This client is a major player in the biotechnology sector, particularly in the field of allogeneic treatments in gene and cell therapy.
As part of its development, this client has launched an investment program including the setting up of a production unit for Starting Material RNA (RiboNucleic Acid), plasmid and vector.
This project, carried out in the heart of Paris, has the characteristic of "transforming" existing R&D/pilot facilities into a GMP production unit.
This customer mandated Assystem Care for all the missions of Commissioning, Qualification and Validation of the direct impact systems, within the framework of a service of Project Management Consultancy (in the form of a fixed-price contract with commitment of results).
Project scope
- Risk / criticality analysis
- Retrospective Design Qualification
- Verification / proofreading of FAT/SAT documentation
- Support for the acceptance and integration of the equipment in its final environment
- Writing of protocols, reports and execution of IQ/OQ/PQ tests
- Management of non-compliances and modifications
- Risk analyses for the definition of QP strategies Environment monitoring and Autoclave
- Setting up a team of 10 to 15 consultants (capacity to mobilize), and varying the size of the team to best adapt to the needs of the project in the context of fluctuations related to COVID-19
Qualified Equipment / Systems: HVAC, clean utilities, rooms, autoclaves, isolators, PSM, thermostatically controlled enclosures, biotech production and analytical equipment, environmental monitoring system
Client benefices
- Significantly simplified IQ/OQ protocol approval with the production of "Master" test sheets
- Rationalization of the testing effort at all levels through the use of criticality and risk analysis
- Qualified equipment within the deadlines despite the time constraints related to the lockdown due to Covid-19, thanks to the fast mobilization of specialized QA resources
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