Requirements Management Tool

Reduce the cost spent on manual traceability



Orcanos Design Input (DI) and Design Output (DO) for requirements management tool simplify tracking of your requirements. Flexible enough to serve SMBs and powerful for enterprises.

  • Single repository for all types of requirements management (DI/DO)
  • Simple Import/Export from Word
  • Collaboration
  • Medical Device compliance, with 21 CFR Part 11 support
  • End-to-end traceability with impact analysis
  • Real-time dashboards, alerts, and notifications

Requirements Management Tool for Medical Devices
Orcanos medical requirements management tool is a perfect fit for manufacturers of medical devices and will provide you with

  • Central requirements management repository
  • Electronic signature, 21 CFR Part 11 compliant
  • Requirements tractability matrix
  • Generate requirements documents
  • Requirements traceability to risks, thus satisfying ISO 14971
  • Supports multiple types of requirements
  • Requirements verification using Orcanos test management tool
  • Full audit trail and history log
  • Baseline management

End-to-End Traceability

Orcanos requirements traceability tool helps companies track coverage and traceability between any ALM artifact, such as system requirements, hardware and software requirements, test cases (see: test management), risk, and more.

Using the Orcanos traceability matrix you can integrate R&D with quality management modules, such as FMEA for risk management, CAPA and customer complaints, thus satisfying medical device regulations.

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Online Document for better collaboration

Orcanos Online Document enables documents collaboration. Multiple users can access the same document together, while preserving document integrity and data security.

MSWord Document Generator

Orcanos DocGen is used to generate documents from Orcanos electronic records repository. Supporting embedded reports, and customized templates.

  • Embedded reports
  • Custom Templates

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Hierarchic Requirements Management View

Create hierarchical documents of requirements with a Word-like online Editor.

Easily build your documents structures according to your organizational needs, use predefined templates and easily share documents between users

This is the moment when you
choose your way to succes.

Requirements Management
Features List


Requirements Editing

Requirements Traceability

Generate Word Documents

Requirements Validation and Verification

Search, Custom Views and Personal Dashbaords

Electronic Signature, Review And Audit

Requirements Baseline And Version Management

Data Sharing And Permissions

Discussions And Instant Messaging

History Log And Audit Trail

Requirements Import And Export

Help And Documentation

Related Links

  • cGMP Part IV
  • Project Planning Gantt
  • cGMP Part V
  • Action Item Management
  • Integration with Zapier
  • cGMP Part VI
  • cGMP – Design Inputs (URS-FRS-MRS-ERS)
  • 21 CFR Part 820
  • Customer Related Processes
  • Design Review
  • Agile Scrum Project Management
  • Design Inputs and Desing Output
  • cGMP – Validation Master Plan
  • 10 Reasons why to use EQMS