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Solutions for Information & Process Management

Simulation is a powerful tool for generating digital evidence of device performance, and verifying that performance requirements are met. Simulation and test data must then become part of a structured verification plan that records and tracks results, providing traceability from requirements to engineering data.
Simulation is a powerful tool for generating digital evidence of device performance, and verifying that performance requirements are met. Simulation and test data must then become part of a structured verification plan that records and tracks results, providing traceability from requirements to engineering data.

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Our solutions provide the platform for integrating simulation and test data into the broader, comprehensive database that comprises the "single source of truth" for your device, allowing you to:
 
  • Define structured verification plans and track activity
  • Create a structured definition of simulation and test contexts (what, when, who)
  • Capture and record simulation and test results in context
  • Provide data access, capture, storage, and reporting
  • Provide multi-domain traceability, change and configuration management--central requirements of sound engineering practice, and your regulatory compliance and reporting

Solution Capabilities

Explore the key areas of this solution.

IoT & Lifecycle Analytics

Leverage the Internet of Things to achieve agility, speed, and compliance at your medical device or pharmaceutical organization. Combine big data information with engineering intelligence contained within the PLM system to provide the insights needed to ensure quality, optimum performance, and overall manufacturing excellence.

Lifecycle Management

Consolidate and connect the output of your existing systems for faster execution and improved productivity. Our lifecycle management solutions for the pharmaceutical industry allow you to do more with your technical information in an integrated, highly accessible, yet secure environment. Whether it’s managing change, executing work processes, improving quality, or connecting external suppliers and customers, it all starts with a holistic approach to centralizing technical information and ensuring it remains up-to-date. The end results are better, more informed decisions across the entire enterprise and better, more effective products for the end-user.

Requirements Management

Manage complexity and continuously improve quality by understanding and intelligently assessing the impact of changes at every stage across the medical device product lifecycle. Our systematic and repeatable solutions for “building in” the voice of the customer enable medical device companies to easily capture, securely manage, accurately verify, and reliably maintain requirements information across the entire development process for safer, more effective products.

Verification & Validation Management

Achieve faster time to clearance by providing a single, integrated environment that ensures all medical device verification events are driven by product requirements. Whether simulation modeling and analysis or physical testing, requirements-driven product compliance can be planned and executed in the correct sequence and linked to individual tests to provide the necessary resources. Our Verification and Validation (V&V) Management solutions provide full traceability throughout the device lifecycle to complete successful product compliance.

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