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Validation of a serialization system 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 serialization system and harmonize its manufacturing processes with a new corporation.

Mandate

Genipro was mandated to act as the site representative computer validation expert to establish migration strategies and prepare the validation documents such as the validation plan, the test plan 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 serialization processes, in an end-to-end approach, including all interfaces with other systems and factory equipment.

Highlights

The serialization project 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.
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