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Life Sciences

DOCUMENTARY SYSTEM EVALUATION PROJECT


The Project
 Evaluation of the documentation system used by the Pharmaceutical Sciences department to document and trace pre-formulation and formulation tests on the R&D site.
 
The general organisation, activities, interfaces and documentary media were studied in terms of what exists and what is possible to comply with this department’s desired goal of improving the traceability of performed tests.


Scope of work assigned to Assystem

  • Evaluation of the existing documentation
  • Evaluation of the different ways of using this documentation in practice
  • Evaluation of the existing traceability system for paper-based and computer-based raw data, and its coherence
  • Evaluation of the different modes of entry and use of paper-based and computer-based raw data in practice
  • List of regulations applicable to this case (including 21CFR11)
  • Presentation to the team of the regulations applicable to this case
  • Preparation of solutions for the improvement of the documentation system
  • Preparation of solutions to improve the traceability of paper-based and computer-based raw data
  • Presentation of these solutions to the team


Results

  • Identification of processes and their weaknesses
  • Classification of remarks according to functional and regulatory impact
  • Recommendation for a type of electronic management solution




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