Client is a large international logistics service provider with more than 300 warehouses, mainly in Europe. One of the verticals is pharma & healthcare. The IT organization is centralized and the quality departments are organized at country level. The instructing party has a pragmatic attitude.
The aim of the assignment is to set up a validated environment for the WMS in accordance with GAMP-5 and GDP for all Pharma sites. This means an explicit and solid collaboration between business and IT.
We started defining the project board so that it reflected the stakeholders. Two senior users (managing directors of the countries where system validation has started), two senior suppliers (one from the IT organization and one from the implementation organization) and as project executive the business development director Pharma.
A clear scoping and phasing was discussed with the project board, sufficient time was used for this and a plan with preconditions (including resources) was subsequently drawn up and approved.
Drawing up the validated environment as well as implementing the validated environment in two countries was ultimately the scoping and phasing.
Monthly project board meeting and two weekly quality department meetings ultimately formed the basis of the approach. In addition, the organization has been looking for document owners to elaborate the various components (procedures, validation, implementation).
Planned and realized turnaround time has been 50 weeks, using less budget than planned. A system validation environment for the WMS has been realized that is operational for two countries (as of November 2017). The expansion to all Pharma countries will be implemented by the standing organization.
The following success factors underpinned this assignment: