Challenge
A top-five pharmaceutical company's GCP framework had grown inconsistent across 130+ countries, creating audit exposure and operational inefficiency. Regulators demanded a unified approach to documentation and governance.
Approach
Scimitar led a global redesign of the company's QMS , establishing a procedural-document framework and appointing global process owners. Cross-functional workshops aligned 150+ participants, role-based SOPs were developed, and modular e-learning was deployed to ensure consistent adoption.
Impact
Procedural documentation was reduced by 80%, global processes harmonized, and the company achieved full inspection readiness across all regions. Continuous-improvement mechanisms were embedded for future audits.
