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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.