Context and challenges
The client is a laboratory specialised in dermo-cosmetics, rheumatology and dermatology.
In order to meet strategic, qualitative, regulatory and quantitative goals (double its production capacity), the client wished to build a new building on one of its production sites.
The new building will enable continuous batch production of the company's flagship dermo-cosmetic products.
With these goals in mind, the client called on Assystem to provide Project Management Office assistance in the Final Preliminary Project phase to help establish specifications, issue a call for tenders and acquire the Industrial Information Systems (IIS) for this expansion project.
Assystem proposed a CSV (Computer System Validation) and data integrity approach:
Topics covered: regulations, data integrity, GAMP5 methodology, associated activities and responsibilities in development phase