project

Computer System Validation and data integrity for a dermo-cosmetic production plant

Compliance / Security Life Sciences France

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 and 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.

Logo Assystem Care

Project Scope

Assystem proposed a CSV (Computer System Validation) and data integrity approach:

  • Training for CSV (Computer System Validation) and data integrity: sharing the same methodologies and vocabulary between all parties involved in the project

    Topics covered: regulations, data integrity, GAMP5 methodology, associated activities and responsibilities in development phase

  • Draft User Requirement Specifications (URS) for the system landscape of the project: MES (Manufacturing Execution System), WMS (Warehouse Management Systems), IT infrastructure, supervisory control, modifications to ERP
    • Workshops on the specifications: compilation of input data, SIPOC methodology (Supplier Input Process Output Customer)
    • Integrate regulatory requirements, in particular data integrity
    • Draft the URS (User Requirement Specifications)
  • Prepare tenders for suppliers: MES, supervisory control and WMS

Results

  • Increased awareness of regulatory requirements for IS and data integrity
  • Introduction of a SIPOC (Supplier Input Process Output Customer) approach to break down processes
  • Pre-selection and tendering for suitable solutions on the market

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