Manage quality and regulatory compliance across the product 
lifecycle

An eQMS is designed for life sciences organizations, including pharmaceutical, in vitro diagnostics, and medical device companies that need to manage quality and regulatory processes.

An eQMS helps organizations meet global regulatory requirements, including FDA, EU MDR, and ISO standards, by providing validated workflows, audit trails, and centralized documentation.

SmartSolve eQMS is designed to support these requirements, enabling teams to maintain audit readiness and ensure consistent compliance across regions and processes.

An eQMS supports a wide range of quality and regulatory processes, including:

• Document and change management
• CAPA (Corrective and Preventive Actions)
• Audit and inspection management
• Quality events, deviations, and nonconformance
• Training and certification tracking
• Regulatory submissions and reporting

SmartSolve eQMS brings these processes together in a single platform to improve visibility, control, and consistency.

AI in an eQMS helps analyze quality data, identify risks and trends, and automate routine workflows.

SmartSolve uses AI and machine learning to help teams detect issues earlier, improve decision-making, and maintain consistent compliance across quality and regulatory processes.

An eQMS supports global organizations with multi-site operations by providing centralized visibility, standardized processes, and scalability to meet regional regulatory requirements.

SmartSolve eQMS is designed for global use, enabling teams to manage quality and compliance consistently across regions and sites.