Our 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 client is pragmatic.
The objective 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 involves an explicit and solid collaboration between business and IT.
Started with defining the project board so that it reflected the stakeholders. Two senior users (managing directors of the countries where system validation 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 subsequently a plan with preconditions (including resources) was drawn up and approved.
The final scoping and phasing was the creation of the validated environment as well as the implementation in two countries of the validated environment.
Monthly project board meeting and two weekly quality department meetings ended up being the basis of the approach. In addition, document owners were sought in the organization to work out the various components (procedures, validation, implementation).
Planned and realized lead time was 50 weeks, using less budget than planned. Realized is a system validation environment for the WMS that is operational for two countries. The expansion to all Pharma countries will be implemented by the standing organization.
A system validation manual has been delivered including a central repository of documentation.
The following success factors underlay this assignment:
- Intensive and regular communication with stakeholders (not only project board).
- Clear project plan with clear expectations to project stakeholders.
- Involvement and execution by subject matter experts.
- Open collaboration by the three quality managers from different countries.
- Follow-up of project activities including project documentation.
- Planned and realized turnaround time is 50 weeks
- Less budget used than planned
- Delivered: system validation environment WMS operational in 2 countries
- Delivered: system validation manual
- Delivered: central repository with documentation.