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The Helix ALM Alternative

The best alternative to Helix ALM, now Perforce ALM, for medical device and life science teams

Last updated Facts checked

Matrix Req is requirements management software built only for life sciences. It comes from a vendor that is independently certified to ISO 13485:2016 and ISO/IEC 27001:2022, and it turns your project data straight into the documents an auditor asks for.

Two way sync with Jira and Azure DevOps, Matrix Mind and the AI Compliance Checker included, and a typical rollout in 2 to 3 months. Trial every feature with no credit card.

For taking a demo with our team.

Helix ALM (Perforce ALM) at a glance
Matrix Req
Helix ALM
Built for
✓ Life sciences only, since 2014
Regulated industries broadly; ISO 26262 certified
Vendor certification
✓ ISO 13485:2016 and ISO/IEC 27001:2022
Not assessed
Reports and documents
✓ Generated from live project data
✗ Hard to build (about 6 of 25 Capterra reviews)
Setup and change
✓ Medical device structure from day one
Configuration effort (about 4 of 25 Capterra reviews)
Dev tool sync
✓ Two way with Jira and Azure DevOps
Not assessed
Price and trial
✓ Trial every feature, no credit card
✗ Quote only

This comparison is based on publicly available information and user reviews as of 20 October 2026. Features and capabilities may change over time. For the most accurate information, refer to the official Perforce website.

Common frustrations with Helix ALM

What Helix ALM (Perforce ALM) reviewers report on G2 and Capterra (reviews read 16 October 2026).

Same product, new name

In March 2025 Perforce renamed Helix ALM to Perforce ALM. It began life as TestTrack and covers requirements, test case and issue management, on premises or in the cloud.

Built for regulated industries broadly

Perforce describes it as a fit for regulated industries with a strong focus on quality and safety, and it holds an ISO 26262 functional safety certification from the automotive world. It is well rated: 4.1 out of 5 from 102 reviews on G2.

Reports are hard to build

On Capterra, about 6 of the 25 reviews we read mention reports and Word export, with reviewers describing reports as hard to build.

Setup and configuration effort

On Capterra, about 4 of the 25 reviews we read mention setup and configuration effort, and that workflows are hard to change once they are in use. On G2, reviewers tag it as difficult to set up and customise.

Ease of use and cost

Capterra gives Perforce ALM 3.6 out of 5 for ease of use, and G2 reviewers tag the product as expensive.

No published price

Perforce does not publish an ALM price. You request a quote.

Requirements management made simple with Matrix Req

The challenge

Managing Requirements, Risk & Traceability across the product lifecycle

  • Siloed RequirementsEngineering, quality, and regulatory teams store requirements in disconnected tools, making it hard to keep information consistent.
  • Regulatory ComplexityMedical devices must meet multiple global standards (FDA QSR, EU MDR, ISO 13485, ISO 14971), each demanding rigorous documentation and audit evidence.
  • Traceability BreakdownsMaintaining end-to-end traceability between design inputs, risks, tests, and outcomes is mandatory. Any missed connections can lead to non-conformities and deferred time to market.
  • Time-Consuming Audit PreparationWithout automated traceability and centralised control, preparing for compliance audits is resource-intensive and stressful.
  • Manual Risk ManagementRisk activities remain disconnected from requirements and tests, requiring manual effort to maintain alignment across the product lifecycle.
  • Collaboration GapsCross-functional teams lack a shared workspace, creating miscommunication and delays between engineering, quality, and regulatory.

Our solution

Complete Traceability, Automated & AI-powered Compliance & Much more.

  • Unified Requirements RepositoryCapture, manage, and organise all requirements, design artefacts, and test cases in one secure system. Every item is versioned, searchable, and auditable.
  • Built-In ComplianceImport your standard, create your own regulatory checklist, and our AI Compliance checker will highlight all the gaps you may have and suggest modifications.
  • True End-to-End TraceabilityLink requirements to design outputs, risks, and verification/validation tests. Live trace reports show exactly who did what, when, and why.
  • Integrated Risk ManagementISO 14971-aligned risk management is built in, not bolted on. Link hazards, mitigations, and residual risks directly to your requirements.
  • AI includedMatrix Mind drafts requirements, risks and test cases, and the AI Compliance Checker imports a standard, builds a checklist and shows your gaps. Both are included, not a paid add-on, and run under a zero data retention agreement with the AI provider.
  • Ready-for-audit documentationGenerate technical documentation and trace tables directly from live project data, with red line comparison between any two versions and signed snapshots. Used for 510(k), PMA and CE Mark submissions.
2014
Building for life sciences only
Matrix One has built software for life sciences only since 2014.
500+
Life science companies
More than 500 life science companies use Matrix One products.
2 to 3
Months to roll out
A typical Matrix Req rollout, from export and mapping to regenerated trace matrix and documents.

See exactly how the two platforms stack up on the criteria that matter most to regulated product teams.

Matrix Req
Helix ALM (Perforce ALM)

Comparison based on publicly available information and user reviews as of 20 October 2026. Features and capabilities may change over time. "Not assessed" means we have not verified the point for Helix ALM.

Fit
Built for
✔ Life sciences only, since 2014
Regulated industries broadly
Typical rollout
2 to 3 months
Not publishedNot published
Free trial
✔ Every feature, no credit card
Quote only
Compliance
Vendor certified to ISO 13485:2016
✔ Certificate published
Not assessedNot assessed
Vendor certified to ISO/IEC 27001:2022
✔ Certificate published
Not assessedNot assessed
Design controls built around IEC 62304, ISO 14971 and ISO 13485
✔
Not assessedNot assessed
Used for 510(k), PMA and CE Mark submissions
✔
Not assessedNot assessed
Documents
Technical documentation and trace tables from live project data
✔
Reports hard to build (about 6 of 25 Capterra reviews)
Red line comparison between any two versions
✔
Not assessedNot assessed
Signed snapshots
✔
Not assessedNot assessed
Integrations
Two way sync with Jira
✔
Not assessedNot assessed
Two way sync with Azure DevOps
✔
Not assessedNot assessed
GitHub and GitLab
✔
Not assessedNot assessed
AI
AI drafts requirements, risks and test cases
✔ Matrix Mind, included
Not assessedNot assessed
AI Compliance Checker (import a standard, see gaps)
✔ Included
Not assessedNot assessed
Zero data retention agreement with the AI provider
✔
Not assessedNot assessed
Matrix Req
Fit
Built for
✔ Life sciences only, since 2014
Typical rollout
2 to 3 months
Free trial
✔ Every feature, no credit card
Compliance
Vendor certified to ISO 13485:2016
✔ Certificate published
Vendor certified to ISO/IEC 27001:2022
✔ Certificate published
Design controls built around IEC 62304, ISO 14971 and ISO 13485
✔
Used for 510(k), PMA and CE Mark submissions
✔
Documents
Technical documentation and trace tables from live project data
✔
Red line comparison between any two versions
✔
Signed snapshots
✔
Integrations
Two way sync with Jira
✔
Two way sync with Azure DevOps
✔
GitHub and GitLab
✔
AI
AI drafts requirements, risks and test cases
✔ Matrix Mind, included
AI Compliance Checker (import a standard, see gaps)
✔ Included
Zero data retention agreement with the AI provider
✔
Helix ALM (Perforce ALM)
Fit
Built for
Regulated industries broadly
Typical rollout
Not publishedNot published
Free trial
Quote only
Compliance
Vendor certified to ISO 13485:2016
Not assessedNot assessed
Vendor certified to ISO/IEC 27001:2022
Not assessedNot assessed
Design controls built around IEC 62304, ISO 14971 and ISO 13485
Not assessedNot assessed
Used for 510(k), PMA and CE Mark submissions
Not assessedNot assessed
Documents
Technical documentation and trace tables from live project data
Reports hard to build (about 6 of 25 Capterra reviews)
Red line comparison between any two versions
Not assessedNot assessed
Signed snapshots
Not assessedNot assessed
Integrations
Two way sync with Jira
Not assessedNot assessed
Two way sync with Azure DevOps
Not assessedNot assessed
GitHub and GitLab
Not assessedNot assessed
AI
AI drafts requirements, risks and test cases
Not assessedNot assessed
AI Compliance Checker (import a standard, see gaps)
Not assessedNot assessed
Zero data retention agreement with the AI provider
Not assessedNot assessed

Watch: Why Matrix Req Is the Best Helix ALM Alternative in 2026

The best Helix ALM alternative in 2026 is Matrix Req.

Switching is easy

Migrate from Helix ALM in 4 simple steps

We handle the heavy lifting. A typical Matrix Req rollout takes 2 to 3 months.
Free migration assessment (30 min)

We analyse your Helix ALM setup and map it to Matrix Req's design control structure.

Export and mapping

Your requirements, risks, tests and links are exported and mapped into Matrix Req, with traceability preserved.

Configure and connect

Workflows, roles and document templates configured for your design control process, with Jira or Azure DevOps sync connected.

Go live in 2 to 3 months

Regenerate your trace matrix and documents from the new project.

“
“I think we easily saved six months by working with Matrix One to create efficient digital workflows.”
CV
Carl Van Lierde
VP Product Development, Vipun Medical
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