SMARTSOLVE® EQMS FOR PHARMA

AI-enabled eQMS for faster, more
reliable pharma
compliance

Trusted by pharmaceutical organizations worldwide, SmartSolve replaces spreadsheets and disconnected tools with a single eQMS for deviations, audits, CAPAs, and approvals to help teams reduce risk and support regulatory readiness.

SmartSolve eQMS

Transform pharmaceutical quality management and GxP compliance

Support patient safety and commercial performance by standardizing and automating GxP quality processes across the product lifecycle.

For quality and regulatory teams, modernizing eQMS capabilities is essential to maintaining inspection readiness, ensuring data integrity, and confidently meeting global GxP expectations. A unified enterprise eQMS provides the structure, traceability, and control required to manage deviations, CAPAs, audits, and change control at scale.

Experience how IQVIA SmartSolve eQMS supports compliant, inspection ready quality operations. Book a live demo to see how it can help transform your global GxP compliance.

FACT SHEET

Maximize Compliance. Minimize Risk.

Discover how an integrated eQMS can streamline quality processes, ensure regulatory compliance, and reduce risk across your organization.

Ready to see the benefits?

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Ready to simplify compliance, reduce risk, and accelerate time-to-market?
Schedule a demo to see how a connected eQMS helps pharmaceutical teams optimize GxP data, improve visibility across quality processes, and make smarter, faster decisions.

IQVIA Proof: Automated Artwork & Labeling Verification

Reduce the risk of costly artwork and labeling errors before they reach production or the market. Pixel Proof is an independent verification solution that automatically compares approved artwork against final outputs to identify visual discrepancies early, supporting compliance, accuracy, and confidence across global markets.

With IQVIA Proof, pharmaceutical teams can:

  • Detect unintended visual changes in labels, packaging, and artwork before release
  • Reduce rework, deviations, and recall risk tied to labeling errors
  • Strengthen inspection readiness with objective, documented verification
  • Complement existing quality systems without adding workflow complexity

Pixel Proof works alongside enterprise quality and content systems to provide an additional layer of prevention, helping teams catch issues earlier, reduce downstream quality events, and protect patient safety.

SmartSolve eQMS Frequently Asked Questions

Get quick answers about SmartSolve’s quality management solutions, features, and best practices.

SmartSolve eQMS improves pharmaceutical quality operations and oversight by centralizing GxP quality processes within a single, connected system. By standardizing workflows for document management, training, deviations, CAPAs, audits, and risk management, quality and regulatory teams gain consistent visibility, traceability, and control across quality activities. This supports stronger governance, reduces manual effort and process variation, and enables more informed, timely decision making across the organization.
SmartSolve eQMS offers a comprehensive set of features that support consistent, inspection ready compliance management across pharmaceutical quality operations. Key capabilities include document and training management, change control, deviation and nonconformance management, CAPA, audit management, risk management, and built in quality intelligence. Together, these features enable quality processes to be executed consistently, tracked with full traceability, and aligned with global regulatory expectations.
SmartSolve supports training and change management by tightly linking training requirements to controlled documents and approved changes within a single eQMS. When processes, systems, or regulations change, training assignments, completion records, and change workflows are managed together, helping ensure personnel remain qualified against current procedures. This integrated approach improves traceability, reduces disruption during change implementation, and supports controlled, compliant adoption of changes across the organization.
SmartSolve enhances collaboration across teams by providing a shared, centralized platform for quality data and workflows across quality, regulatory, and operational functions. Standardized, connected processes and real time visibility enable teams to coordinate activities, access consistent information, and make informed decisions without relying on disconnected systems. This supports cross functional alignment while maintaining accountability, traceability, and compliance control.
SmartSolve eQMS supports continuous GxP inspection readiness by centralizing controlled records, standardized workflows, and complete audit trails across quality processes. Documentation, training records, deviations, CAPAs, and audit evidence are managed within a single system and maintained in an inspection ready state, enabling quality and regulatory teams to retrieve accurate information quickly and respond efficiently to inspection requests. This reduces compliance risk, strengthens data integrity, and increases confidence during regulatory inspections.
SmartSolve eQMS helps pharmaceutical organizations manage audits by capturing and organizing quality records within a single system of record. Audit trails, version control, and role based access provide clear traceability of actions and decisions, while integrated workflows support the tracking and resolution of audit findings. This enables QA and RA teams to demonstrate compliance consistently across internal and external audits.

Pharmaceutical organizations often use automated visual inspection solutions to verify printed packaging against approved artwork before release. These tools perform pixel level comparisons to detect deviations in graphics, text, colors, barcodes, 2D codes, and Braille that are difficult to identify through manual review.

When used with SmartSolve eQMS, solutions such as Pixel Proof guide users securely and quickly through structured inspection workflows and record results with audit trails and electronic signatures, supporting traceability and release readiness in regulated packaging operations.

Yes. SmartSolve eQMS is designed to support validation activities and align with regulatory expectations for pharmaceutical quality systems. The platform provides configurable workflows, controlled documentation, and full system traceability to support validation, change control, and ongoing compliance. This enables organizations to align quality processes with regulatory requirements while maintaining the flexibility to adapt as business needs and regulations evolve.
SmartSolve eQMS supports quality management across the pharmaceutical product lifecycle, from early development through commercial manufacturing and post market operations. The platform enables quality and regulatory teams to manage GxP processes consistently as products progress through different stages, supporting compliance, risk management, and continuous quality improvement throughout the lifecycle.

Yes. SmartSolve is suitable for small and emerging biopharma companies and is designed to scale as organizations grow.

For early stage teams, SmartSolve Fundamentals provides a streamlined, pre configured QMS that supports essential quality processes such as CAPA and document management without requiring extensive IT resources. This allows lean organizations to establish compliant, inspection ready quality processes quickly and efficiently. As companies mature, they can seamlessly expand into the broader SmartSolve platform to support increased scope, complexity, and global operations.

 

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