Reduce compliance risk and accelerate approvals with a unified platform that connects quality and regulatory processes across the product lifecycle.
SmartSolve empowers organizations to automate and unify quality processes on a single platform, streamlining regulatory compliance, enhancing product quality, and driving continuous improvement.
SmartSolve eQMS helps MedTech and Pharma organizations reduce time to market while staying compliant. With closed-loop automation across 20+ life sciences modules, it streamlines CAPA, audits, and supplier workflows from design to post-market. SmartSolve supports ISO 13485 and FDA 21 CFR Part 820 requirements, so you can move forward with confidence.
SmartSolve RIM connects global regulatory processes with quality management—using shared master data, configurable workflows, and enterprise integrations to streamline compliance across markets. For device manufacturers, it offers direct, bi-directional eMDR connectivity to the FDA’s Electronic Submission Gateway, reducing manual effort and speeding up post-market submissions.
SmartSolve Fundamentals helps teams manage risk, eliminate variance, and ensure audit readiness with workflow-driven compliance, secure cloud integration and minimal IT effort. As your business grows, the platform scales seamlessly to support enterprise QMS needs and unlocks access to integrated Regulatory Information Management (RIM)—enabling cross-functional visibility and faster, more predictable approvals.
Real-world results that demonstrate how strategic transformation delivers measurable business value.
Increase in productivity and speed with optimized
Decrease in deviations / NCRs
Increase in new product development efficiency and speed to launch
Get quick answers about SmartSolve’s quality management solutions, features, and best practices.
Yes. SmartSolve uses assistive AI for document classification, duplicate detection, and smart linking, speeding up workflows while maintaining full human oversight.
AI is compliant with 21 CFR Part 11 and Annex 11 and never makes regulatory decisions.
SmartSolve offers:
IQVIA also provides:
SmartSolve AI is part of IQVIA’s modular, scalable eQMS platform. It uses assistive AI to streamline quality and regulatory processes—such as design control, document management, CAPA, and post-market surveillance—while maintaining full human oversight and auditability.
Ideal for: Medical device, IVD, and mid-size pharmaceutical companies.
Learn more: Contact IQVIA for a personalized demo.
No. IQVIA SmartSolve eQMS is a software solution for managing quality and regulatory compliance. It is not associated with water-soluble packaging materials.
No. IQVIA SmartSolve is a validated enterprise platform for life sciences, not an academic or homework-related app.
It supports:
SmartSolve was originally developed by Pilgrim Quality Solutions and is now part of IQVIA Technologies. While “Pilgrim” may appear in legacy documents, SmartSolve is the current, fully supported platform for enterprise quality and regulatory management.
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