The Project
The validation method was first initiated on a site covered by FDA regulations then extended to the two other sites.
To optimise resources and competencies, a joint Assystem and PWC validation team was created, each acting within a well-defined functional perimeter. This team acted as operating support with respect to the project prime contractor IBM.
The chosen method aimed to make the most of all test phases within the scope of the validation, including for non-pharmaceutical areas. The aim was to ensure full and uniform documentation and traceability for the project, to ensure operation under ideal conditions, in particular during the start-up phase.
Scope of work assigned to Assystem
The scope of work assigned to Assystem relates to production (PP), scheduling, purchasing, stockrooms (MM-WM-HUM), quality control (QM), status management, master data management and the validation of imported data.
The approach used integrates the following phases:
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- Definition of validation approach and methodology
- Review of User Requirements Specifications (URS)
- Review of Functional Specifications (FS)
- Risk analysis, including complete traceability, from URSs to individual tests and integration tests
- Definition and preparation of individual test protocols and sheets (TU)
- Definition and preparation of integration test and overall test protocols and sheets (TI, overall QO)
- Integration of 21CFR Part 11-related issues
- Definition and preparation of QP test protocols and sheets (before and after startup)
- Definition and preparation of data import test protocols and sheets
- Management of test phases, anomaly handling and changes
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