IQVIA’s SmartSolve eQMS Change Management standardizes and secures change control across facilities, processes, documents, systems, and products. It records and tracks every aspect of change, manages temporary deviations, integrates across quality systems, and provides complete oversight of regulatory-impacted changes. Features include configurable workflows, impact assessments, automated approvals, rollback planning, dashboards, and alerts. It ensures compliance with FDA 21 CFR Part 11, EU Annex 11, and ISO standards through role-based security, audit trails, and e-signature support. Integrated with SmartSolve Document Management and RIM Smart, it enhances collaboration, visibility, and compliance-driven decision-making.

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