Choosing the Right Requirements Management Software in Regulated Industries

Managing product requirements isn't just about documentation—it’s about making sure your entire development process is aligned, traceable, and audit-ready from day one.

In industries like medical devices, pharmaceuticals, automotive, and defense, the stakes are high. You’re not just building products—you’re proving to regulators that every requirement has been met, every risk accounted for, and every test passed.

That’s where the right Requirements Management (RM) system makes a difference.

Why a Requirements Tool Matters (Especially If You’re Using Word or Excel)

Many teams still rely on Excel, Word, or disconnected tools to manage product requirements. It works—until it doesn’t.

• A requirement gets updated, but the test case doesn’t.
• Someone deletes a row in a shared spreadsheet.
• You can’t find the latest version during an audit.
• There’s no traceability between what the customer asked for and what was actually built.

We’ve seen it all.

That’s why Orcanos offers a fully integrated requirements management platform, purpose-built for companies that operate under strict regulatory guidelines.

What You Actually Need in a Requirements Tool

If you're evaluating tools, here’s what you should be looking for—based on real-world project needs:

✅ 1. Centralized Requirements, No Silos

Orcanos lets you manage everything from user needs, system requirements, design outputs, tests, risks, and even CAPAs—in one place. No more hunting across folders, tools, or spreadsheets.

✅ 2. Real-Time Traceability

Forget manual trace matrices. With Orcanos, every requirement is automatically linked to its corresponding test case, risk item, design document, or change request. You can generate up-to-date traceability reports in seconds—ideal for internal reviews or regulatory audits.

✅ 3. Built for Compliance from the Ground Up

Whether you're preparing for FDA submission or ISO 13485 certification, Orcanos has you covered:

• Electronic signatures (21 CFR Part 11 compliant)
• Full audit trail of changes
• Document control and versioning
• Validation-ready templates

✅ 4. Collaboration That Works in Regulated Teams

Orcanos lets cross-functional teams (R&D, QA, RA, suppliers) work on the same set of requirements with role-based permissions, workflows, and approval processes. You stay in control, but everyone stays aligned.

✅ 5. Scalability That Matches Your Growth

From a single product line to a portfolio of hundreds of SKUs, Orcanos scales with you. Cloud or on-premise deployment, multi-site support, API access, integrations with Jira and DevOps—it’s all there.

Why Orcanos?

We don’t just give you a tool—we give you a connected environment that ties together every moving part of your product lifecycle.

Orcanos combines:

• ALM (Application Lifecycle Management)
• QMS (Quality Management System)
• Requirements, Risk, Test, and Design Control
• All in one unified, validated platform.

This means fewer tools, less duplication, and zero surprises at audit time.

Use Cases We Support

• You want to connect risk analysis (ISO 14971) directly to your system requirements.
• You need traceability from user needs to test results before design freeze.
• You’re preparing a Design History File (DHF) and want to automate it.
• You’re handling multiple design changes and need full change control.
• You’re managing both hardware and software components and need a single traceability matrix.

Orcanos does all of that—out of the box.

What You’ll Gain

• Time Savings: Eliminate hours of manual tracking and document generation
• Risk Reduction: Catch gaps early and reduce the chances of compliance issues
• Faster Audits: Respond quickly with auto-generated trace matrices and history logs
• Better Team Alignment: No more miscommunication between R&D, QA, and RA
• Confidence: Know that everything is documented, traceable, and ready for inspection

Ready to Get Control Over Your Requirements?

Whether you're managing a single medical device or building a full pharma platform, Orcanos can help you:

• Launch faster
• Stay compliant
• Work smarter

👉 Schedule a live demo

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