Fact Sheet
SmartSolve® Document Management
Feb 26, 2026
SmartSolve® Document Management is an AI‑enabled, Microsoft Azure–based solution that centralizes controlled regulatory and quality documents for MedTech and Pharma organizations. It supports global compliance requirements including FDA 21 CFR Part 11 and EU Annex 11, enabling secure authoring, review, approval, version control, and full audit traceability across the product and process lifecycle. Integrated with SmartSolve® RIM and QMS modules, the platform streamlines submission‑ready documentation, SOP management, training enforcement, and enterprise‑wide compliance oversight.

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