QMS for Combination Products

Solutions for the complex quality and compliance landscape of Combination Products

Combination Products QMSThe Life Sciences industry finds itself in an interesting place. Innovation is occurring in medical device combination products, and it is a major growth market for the industry. Yet staying abreast of the regulatory and quality compliance requirements of combination products can be quite a challenge no matter where you are located: US (FDA), Australia (TGA), and Europe (EMA), or the rest of the world (ROW).

The road to regulatory and quality compliance is a complex one, and it starts early in the process with the classification of a product as a combination product and the definition of its Primary Mode of Action (PMOA). Combination product companies in the United States find themselves in a unique position. Not only do they need to comply with the cGMP for combination products (21 CFR Part 4), they also need to be concerned with the compliance and quality of the constituent parts of the combination product. This means compliance to 21 CFR Part 210 and 211 (drug) and 21 CFR Part 820 (device) cGMPs.

While cGMPs clearly have much in common, they also differ because they're each designed to address the characteristics of the products to which they pertain. One simple example is CAPA. In the Device regulations, CAPA requirements are quite specific. In the Pharmaceutical regulations, CAPA principles are included in multiple parts of the cGMP. Therefore, organizations whose core competency is Pharmaceutical are likely to find themselves struggling with design controls, purchasing controls, installation, service, and CAPA. Similarly, organizations with a core competency in Medical Devices are likely to struggle with yield calculations, packing, testing for release into distribution, stability testing, and expiration dating.

The 21st Century Cures Act Section 3038 also improved the regulation of combination products through faster assignment of the combination product to a primary agency center (CDRH, CDER, or CBER), quick assignment of PMOA, and defining the process for resolving disputes.

Whether your organization is new to combination products or offers combination products that have been on the market for years, Pilgrim Quality Solutions can assist with our medical device combination products quality management system.

Whether you need to develop a risk-based CAPA process, ensure that your team is adequately trained and following procedures, keep suppliers under control, investigate out-of-specification lab results, manage design-related change, or structure your quality system data to support quality metrics and reporting, SmartSolve gives you integrated quality management solutions and capabilities to achieve your goals.

SmartSolve QMS Solutions for Combination Products



Plan, manage, and conduct internal, supplier, and regulatory audits.

Implement a risk-based corrective and preventive action process for regulatory compliance.

Ensure consistent and compliant change throughout the organization.

Streamline complaint handling and regulatory reporting.

Build a foundation for quality and compliance.

Streamline incoming inspection based on supplier risk.


Capture, resolve, and track both supplier and internal defects.

Ensure consistent out-of-specification lab result investigations

Evaluate and manage product recalls and corrections.

Identify and focus on the suppliers that matter most.

Ensure a competent, compliant workforce.


Quality Intelligence Brings Actionable Insight

SmartSolve lets you gain insight over your quality management operations with built-in tools for monitoring key processes. You can keep tabs on trends, share reports throughout your organization, or get more hands-on with data analysis with our quality intelligence tools.

Tools to Tailor, Extend, and Integrate Quality Processes

Pilgrim’s QMS solutions for Combination Products are developed on SmartSolve's Platform for Compliance. SmartSolve's Configuration Tools, Platform Services, Enterprise Integration capabilities make it easy to tailor, extend, and integrate processes as the demands on your quality management system grow. Plus, Pilgrim's secure, cloud-based deployment options and automated validation tools help your team get up and running on new processes quickly.





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