Digital QMS Implementation


Client Type A rapidly growing biopharma
Function Evaluation and implementation of a digital QMS system to take a rapidly growing biopharma from a paper-based to a digital system.
Challenge Paper QMS ahead of launch
Impact Fully digital QMS operations

Challenge

A rapidly growing biopharma was utilizing a paper-based QMS system. As assets approached commercial launch, this was becoming cumbersome and impractical for the quality organization to effectively manage.

Approach

Scimitar led the evaluation, selection, and implementation of a digital QMS solution with the Quality organization and key functional stakeholders. Key business requirements were identified for solution selection, along with a phased rollout plan of which capabilities were required to be deployed at points in time to the organization.

Impact

The organization was able to successfully migrate from a paper based to a digital QMS system and start managing all operations in the digital system – procedural documentation and quality event management.

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