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Requirements Traceability

Ensuring quality and regulatory compliance while also delivering best-in-class, innovative medical devices has never been more important. Our Operational Excellence solutions enforce regulatory compliant manufacturing operations while enhancing the ability to define, schedule, execute and assure manufacture processes that optimize quality and efficiency. Additionally, our product analytics solutions provide proactive quality insights and decision-making support based on manufacturing and quality big data.

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Requirements Traceability

Ensuring quality and regulatory compliance while also delivering best-in-class, innovative medical devices has never been more important. Our Operational Excellence solutions enforce regulatory compliant manufacturing operations while enhancing the ability to define, schedule, execute and assure manufacture processes that optimize quality and efficiency. Additionally, our product analytics solutions provide proactive quality insights and decision-making support based on manufacturing and quality big data.

Challenges of Requirements Traceability

Requirements Traceability from A to Z

The FDA and other regulators continue to emphasize mature quality assurance practices over baseline compliance activity. This heightened focus, referred to as the Case for Quality, along with globalization, economic factors, and a growing and competitive marketplace, are key factors driving Operational Excellence within the medical device industry. Similarly, greater device complexity and the increased occurrence of safety issues and recalls have heightened the need to enforce quality, efficiency and traceability in manufacturing operations.

Medical device organizations must produce devices using a digitalized manufacturing platform that provides production, supplier and purchasing controls. They must also take advantage of advanced big data product analytics to improve quality, reduce operational costs and mitigate risks.

Our proven Operational Excellence solutions deliver this critical functionality, enabling medical device organizations to excel.

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