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Validation of an ERP system (SAP) migration
Client
Pharmaceutical
Location
Montreal area (Quebec), Canada
Service
Qualification and validation
Context
As part of a corporate migration, our client had to upgrade and migrate its ERP system and harmonize its business processes with a new corporation.
Mandate
Genipro was mandated to act as the site's representative IT validation expert to establish migration strategies and prepare the validation documents such as the validation plan, the data migration plan, the test plans as well as the validation protocols and reports. Our mandate also aimed to coordinate, with subject matter experts from different departments, the writing and execution of test scenarios for all business processes, in an end-to-end approach, including all interfaces with other systems (LIMS, MES, factory equipment). The tests stringency and intensity had to be established based on the criticality of each process. All the processes had to be rigorously verified, from the purchase of raw materials, through production and packaging planning, manufacturing, packaging, and releasing of batches, up to the shipping of finished goods.
Highlights
As the project took place during the COVID19 pandemic, the implementation of sanitary measures on the customer site brought additional complexity since the site was temporarily inaccessible to the team. The rigorous coordination of all experts involved was essential to the success of this project since most of the work had to be carried out by resources working remotely in different time zones. The verification of the new ERP system was carried out in two stages, the first as an informal execution using the ERP software installed in a test environment (uncontrolled) to ensure that protocols and methods were adequate. The second step was a formal execution of the qualification protocols using the ERP software installed in a quality environment (controlled) replicating the production environment and was carried out physically on the customer site. This step had to be carefully planned to have the necessary resources on site while respecting the sanitary measures constraints. Once the new ERP system was qualified, all the data could be extracted from the old ERP system and migrated to the new qualified ERP system. The data migration was carried out according to a migration plan and verified using a migration protocol to finalize the transition to the new corporation. The data migration was executed as part of a plant shutdown aimed at the complete transfer of the site from one corporation to another. The planning and scheduling of the protocol’s execution represented a challenge as the project team had to deal with numerous constraints while meeting all objectives as well as the tight project schedule.