5 Questions to Ask When Evaluating Compliance & Traceability Solutions
As small-to-medium-sized businesses (SMBs) in highly regulated industries grow, managing requirements and getting complete product development traceability manually becomes increasingly difficult and burdensome. A dedicated requirements management tool is essential for maintaining traceability — especially for medical device lifecycle management and other safety-critical work. But many tools on the market do not truly offer end-to-end traceability, and SMBs face the unique challenge of finding affordable traceability software that offers all the functionality they need to achieve and automate compliance.
What you’ll learn from this buyer’s guide:
- The challenges and risks involved with using spreadsheets, lightweight tools, and manual processes for requirements management — especially for safety-critical work like medical device risk management.
- Use cases for requirements management software — like fully automating traceability and achieving compliance certifications ahead of schedule.
- 5 questions SMBs in regulated industries should ask vendors when evaluating ALM software and traceability solutions for requirements management.
- How Helix ALM application lifecycle management software from Perforce automates, simplifies, and streamlines requirements management for SMBs.
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For 14+ pages of details on what to look for in an ALM project management tool for requirements management, traceability, and compliance, complete the form to download your free copy.
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Why Helix ALM is the Best ALM Software to Automate Compliance & Traceability
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Helix ALM is an ALM management tool that empowers your team to deliver quality software on time. You’ll always know the status of your projects. And you’ll be able to trace requirements, issues, and test cases through the lifecycle.
Reduce. Reuse. Report.
Gain efficiency in development. Reduce risk through ruthless QA processes. Reuse requirements and test cases where it makes sense. And report on every project detail. Make projects like medical device compliance much more streamlined, automated, and traceable.
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Break your requirements and test cases out of Microsoft Office. With Helix ALM, it's easy to share requirements, collaborate on issues, and manage test cases across global teams thanks to capabilities like automated trace matrices, bi directional traceability, and more.
“Because of the complex workflow I’ve created within Helix ALM, it’s impossible for my team to accidentally miss a regulation or compliance standard. They are guided step-by-step to the finished product.”
Learn the 5 Questions to Ask When Exploring ALM Software for Product Development Traceability
Access your free copy of our Requirements Management Software Buyer’s Guide now to discover what teams in regulated industries need from audit and compliance software for requirements management.
Frequently Asked Questions
Helix ALM (application lifecycle management software by Perforce) is a comprehensive ALM management solution for managing product development processes, including requirements, testing, and issues. It ensures product development traceability by giving teams a modular suite of ALM tools to trace requirements, tests, and issues. You’ll know if requirements have been tested and met, if test runs have passed (or failed), and if issues have been resolved. Plus, if a requirement changes, you’ll know which test cases and issues will be impacted.
Complete traceability is essential for managing medical software requirements and proving compliance in any regulated industry. As a robust ALM application, Helix ALM streamlines and automates end-to-end traceability across the product lifecycle, ensuring that all regulatory requirements are tracked, verified, and met. Helix ALM also automates documentation and reporting, making it easier to achieve and maintain compliance with industry standards and regulatory bodies such as the FDA, ISO, and others.
Medical device compliance is critical for meeting regulatory standards. Helix ALM provides a comprehensive solution for managing medical device requirements and ensuring full bi directional traceability across the product lifecycle. This is essential for maintaining compliance with regulatory standards such as FDA and ISO 13485. By linking medical device requirements with issues and test cases, Helix ALM offers end-to-end medical device traceability.
Helix ALM is robust application lifecycle management software that offers end-to-end traceability and impact analysis. It supports efficient regulatory change management by automating the process of tracking, managing, and implementing changes to requirements, test cases, and issues throughout the product development lifecycle. It ensures that any changes that impact regulatory compliance are documented and linked to affected artifacts, facilitating compliance with evolving standards and reducing the risk of non-compliance. Additionally, Helix ALM automates workflows, streamlines approvals, and helps teams collaborate effectively on regulatory updates.
Yes! Helix ALM simplifies and helps automate RTM project management by automatically generating traceability matrices that link requirements to all artifacts, test cases, and issues. This is especially useful for medical software compliance projects and product development in any safety-critical industry where compliance and traceability are paramount. In short, Helix ALM Helix ALM makes it much easier for teams to ensure all regulatory requirements are met.