Case Study: Global Chemistry-Based Drug Discovery and Development Company achieves 50% faster document reviews, full traceability, and FDA compliance with MetricStream

Automating Document Management For Efficiency, Visibility, and FDA Compliance

A global chemistry-based drug discovery, development and manufacturing company faced rising costs and regulatory risk as rapid growth and a move into contract manufacturing exposed the limits of a manual, spreadsheet-driven document control process. Lack of visibility into review cycles, inconsistent quality practices across sites, and multiple uncontrolled SOP copies made cGMP and FDA compliance increasingly difficult and unpredictable.

Since February 2004 the company has used MetricStream’s Document Management Solution to centralize documents, enforce lifecycle workflows, role-based access, electronic annotations, and automated notifications. The result: review cycle times cut by more than 50%, 100% traceability and easier search/access, reduced risk of non-compliance, validated 21 CFR Part 11 controls, and organization-wide adoption with real-time reporting and dashboards for operational oversight.