Traceability & Visibility of the Complete Development Lifecycle
The Helix Development Platform delivers enterprise-class solutions that minimize product development risk and increase auditability of the entire development lifecycle. With Helix ALM and Helix Core, product teams get full traceability of the complex relationships and artifacts of the project management process from requirements to test, as well as the full history of access and change to source code and binary files—delivering auditors proof of a controlled, quality process.
The Helix Development Platform includes the solutions that provide effective traceability by allowing teams to document the life of the product development process, so that every artifact can be easily traced back to the originator of the initial request.
By creating relationships and links between development artifacts such as requirements, test cases, test results, resolutions, and source code, the fully integrated Helix ALM and Helix VCS together allow stakeholders, managers, and regulators to quickly review, from a high level, every action and decision within the product development lifecycle or drill down to detailed information as needed.
For quality-critical industries, risk management is a foundational issue, with organizations assessing risk from the earliest concept and feasibility phases. For teams managing risk assets in Microsoft Word and Excel, management can quickly get out of control once an organization moves from the feasibility phase to design control.
Helix ALM provides a single solution for improving risk visibility and tracking, with automatic notifications and escalations, automatic audit logging, and electronic signatures that are incorporated into your organization's daily development and quality assurance processes.
Companies dedicate precious time to crafting reliable traceability matrices, often a mandated requirement for regulatory compliance. Some organizations lose weeks of productivity on this one task! But with Helix ALM, development teams can automate this process, generating a traceability matrix in minutes and linking downstream artifacts to requirements.
A well-maintained traceability matrix helps estimate testing requirements, provides visibility of changes throughout the product development cycle, and makes audits much smoother. Most importantly, an automated traceability matrix serves as evidence that all requirements have been implemented and tested, with hazard mitigations set and validated for effectiveness.
Change Impact Analysis
The Helix ALM impact analysis tool takes the guesswork out of understanding and approving requirement changes. Quickly observe the scope of changes in an entire project and make better choices about which changes to approve.
With seamless forward and backward impact analysis, software compliance teams get a clear picture of relationships between items and how changes will affect requirements. A better view of linked relationships ensures that changes are not missed and do not negatively affect the project outcome.
When tests fail, and they will, Helix ALM can link the test run to the failed defect to provide traceability from the test case to the resolution of the failure. In fact, Helix ALM can trace from a requirement all the way to the source code changes made in Helix VCS to resolve a defect.
In addition, Helix ALM can force sign off on each test step during testing if compliance rules require it. This configurable option improves traceability in regulated environments.
Essential Traceability for Life Sciences
Better audit tools. Better medical devices.
As you design new medical products, multiple activities, changes, and requirements must be tracked, documented, and responded to by multiple stakeholders. Learn how an automated project lifecycle management solution can trace every relationship and change, and provide instant visibility into data.
Measure Risk in the Enterprise
Helix ALM and Helix VCS are built on expert insight from development professionals in quality-critical industries. From life sciences, automotive, and banking and finance, Helix helps organizations measure, identify, and eliminate compliance risk with end-to-end design control measures.
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