Modern Requirements tools that are trusted by the world's leading healthcare & medical device companies.
Reliability, safety, security and quality-control factors drive success and contribute to the reputation of companies. With their landscapes further complicated by evolving regulations and compliance, these organizations rely on proven technologies like Modern Requirements4DevOps built into Microsoft’s industry leading Azure DevOps.
Maintain auditability through the use of our one-click reporting tools. Create difference reports show the changes between two sets of work items, or review audit reports complete with timestamps.
Build requirements and documentation at the same time using our industry-recognized Smart Docs tool. Allow your team to build documentation directly within your Azure DevOps/ TFS projects.
Report on your test coverage by creating Traceability Matrices that can be easily turned converted into Excel Documents. Identify orphaned requirements and build coverage quickly and easily.
The only Requirements Management tools built into Azure DevOps
for Healthcare and Medical Device companies
Define and Mitigate Risk and Hazards
Our Requirements Management solutions offer teams the ability to easily create Risk and Hazard work items that define and link Risks and Hazards to other requirements within your project. We even offer fully compliant requirements templates that allow you to get started with your Azure DevOps project quickly and with everything you need to mitigate Risks and Hazards.
Manage Reviews and Approvals of Requirements
Use our CFR 21 Part 11 Compliant online reviews to streamline your approval process. Remove approval delays by actively involving your Stakeholders in the approval of both Azure DevOps Work Items as well as Requirements Documents you create in our Smart Docs module (built seamlessly into Azure DevOps). To increase auditability, we allow you to easily request e-signatures, or create one-click reports that detail, and timestamp, all actions, comments, and changes that occurred during a review process!
Book a demo with us today and see how we uncomplicate compliance.
Let us show you how Documentation, Reviews, Baselines and can be built directly in Azure DevOps.
Control Release Scope with Baselines
Use Reviews and Baselines in tandem to easily facilitate, identify, and manage the changes to requirements. Our workflow tools provide your team with the ability to easily manage scope creep and identify places where changing requirements need to be reassessed. We also support the ability to Reuse Baselines across projects, and roll-back work item Baselines without losing any data.
Ensure Requirements and Test Coverage
Use fully configurable, and always up-to-date, traceability matrices that allow you to easily ensure traceability project wide. With two powerful matrix types, our Trace Analysis tool offers teams the full capabilities required to maintain project-wide end-to-end traceability. Our matrices can be created in minutes and are always up-to-date. This allows team to easily view project traceability quickly, with the ability to turn any matrix into a distributable report with the click of a button.