Requirements Management

The Requirements Management module is designed to help you build with clarity and deliver with confidence by defining and tracking product requirements with complete traceability. It connects user needs, design inputs and outputs, and risk controls, facilitating a streamlined design process that is audit-ready.

Simplify Requirements. Strengthen Compliance. This module links user needs, inputs, outputs, validation, and verification, ensuring comprehensive traceability. By connecting risk controls to design inputs, it provides a complete view from hazard identification to verified results, ensuring compliance throughout the development process.

Connect Requirements Inputs to Outputs, Risks and Results

Product requirements can be easily described and connected across various elements such as user needs, design inputs/outputs, validation, and verification. This ensures full traceability and compliance at every stage of development.

Assess Change Impact Instantly

The module allows you to track how design changes affect connected elements like inputs, outputs, and verification results. It automatically highlights potential impacts, enabling your team to manage product changes efficiently and confidently throughout the product lifecycle.

With this module, you can ensure traceability, simplify design control, and accelerate development. It allows you to define, link, and track requirements across user needs, design inputs/outputs, risk files, and verification activities. The out-of-the-box functionality offers ease of use and compliance, while built-in tools support team collaboration and traceability, all within one connected eQMS system. It is flexible enough to support any device, system, or market, adapting to your development needs without added complexity.