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Data integrity mitigations and remediations

Client

Pharmaceutical


Location

Montreal area (Quebec), Canada


Service

Qualification and validation

Context

Data integrity is an issue currently receiving close review in the pharmaceutical industry. The client wanted to upgrade their systems for an entire production site.

Mandate

Genipro was mandated to manage the data integrity remediation/mitigation projects. The team assessed gaps, developed action plans, monitored project progress, and validated changes made.

Highlights

The main challenge was to employ creativity and ingenuity to implement solutions in the context of budget cuts while complying with the requirements of pharmaceutical regulations and corporation policies. Also, the versatility of the Genipro team made it possible to improve data integrity on a wide variety of equipment, instruments, systems, and software.
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