IQVIA SmartSolve eQMS Change Management standardizes change control across life sciences operations, ensuring compliance with FDA, EMEA, and ISO regulations. The system records, reviews, and implements changes across facilities, processes, documents, systems, and products. Key features include workflow automation, impact assessments, integration with SmartSolve Document Management, and regulatory oversight via RIM Smart. Temporary changes and deviations can be managed separately for audit readiness. Secure records, audit trails, and role-based access support compliance with FDA 21 CFR Part 11 and EU Annex 11. User-friendly dashboards, alerts, and reporting enhance visibility, collaboration, and quality assurance.

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