Challenge
A global pharmaceutical company's QMS system had sprung many "variants" based on its global operations resulting in complexity, procedural document duplication, and inconsistency in its operations as it prepared for new product filings globally
Approach
Scimitar led a global redesign of the QMS to create a singular, global QMS to streamline compliance. Cross-functional workshops with 100+ stakeholders were conducted to gather global and regional requirements, streamline procedural and policy documentation, re-align role-based training, and create new modular e-learnings for QMS adoption.
Impact
Procedural documentation was reduced by 50%, global processes harmonized to account for regional variances, and the company was successfully able to gain product approval in the US and EU under the new QMS.
