Enabling a CDMO to Modernize Validation and Save 1.5 FTE Annually

A contract development and manufacturing organization faced outdated, paper-based validation processes and a backlog exceeding five releases, limiting its regulatory competitiveness. Sware deployed its Res_Q Validation Management Platform to consolidate validation activity across multiple sites, migrate historical records, and establish standardized, fully traceable processes. The company now projects savings of "1.5 FTE annually on ERP validation efforts alone" and has achieved FDA audit-readiness with modernized, end-to-end traceable validation documentation.

Sware is a GxP validation platform whose entire commercial focus is life sciences — used specifically to validate AI/ML systems' explainable, traceable decisions for regulatory scrutiny.

This sits in the Scale & Govern stage of the AI use-case lifecycle: Named examples from the tools pharma teams use to monitor, govern and keep validating an AI system once it is already live in production.