Requirements Management Tool

Reduce your Manual Traceability cost spend

Free Trial? Contact Us

Schedule Demo

The product lifecycle is filled with challenges and potential pain points that can add time and money to the process. More often than not, there will be ambiguities that arise throughout the development stages – assumptions, grey areas, wishful thinking, for example – that need to be identified as early as possible.

Orcanos’ Requirements Management Tool has been designed to simplify requirements tracking. Flexible and powerful enough for both enterprise-size organizations and SMBs, the Design Input (DI) and Design Output (DO) tool has the following features:

Single repository for all types of requirements management (DI/DO)
Simple Import/Export capabilities from Microsoft Word/Excel/CSV
End user or stakeholder collaboration
Compliance with 21 CFR Part 11
End-to-end traceability with impact analysis
Real-time dashboards, alerts and notifications

Requirements Management Tool for Medical Devices

Our medical requirements management tool is perfect for manufacturers of medical devices and will provide you with a number of essential quality-related features. These include:

Central requirements management repository
Electronic signature (21 CFR Part 11 compliant)
Ability to generate requirements documents
Requirements traceability to risks, ensuring compliance with ISO 14971
Support for multiple types of requirements
Requirements validation & verification using Orcanos test management tool
Full audit trail and history log
Baseline management for design control

End-to-End Traceability

Orcanos requirements traceability tool helps companies track coverage and traceability between any ALM artifact, including but not limited to system requirements, hardware and software requirements, test cases (see: test management) and risk.

In fact, by using the Orcanos traceability matrix you can integrate R&D with quality management modules, such as FMEA for risk management, CAPA and customer complaints, ensuring medical device regulations are kept.

Online Document Review for better collaboration

Orcanos Online Document module 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

Learn More

Requirements management Tree

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 success.

Requirements Management

Features List

General

Add/edit/del/query requirements in a single repository
Manage entire lifecycle
prioritization
Capture source of requirements
Define a stakeholder for each requirement
Define and capture different types of requirements with full customization
Customize requirement attributes and layout
Manage backlog
Data reuse
Copy & Share
Automatically create unique ID for each requirement
Classify requirements by attributes
Mass update of attributes
Create custom lists
Various exporting capabilities
Restrict two people from working simoultaneously
Drag-and-drop ability to move requirements within the document
External API available for automation

Requirements Editing

Embedded HTML editor
Automatically check requirements for spelling errors

Requirements Traceability

Trace requirements at all levels
Support upstream and downstream Traceability
Full traceability matrix, summary and detailed view
Impact analysis
Cross-Project Linking capability.
Use baselines to track chnages
Identify missing links
Navigate upstream and downstream
Define link types
Generate traceability reports

Generate Word Documents

Export requirements to Word/PDF/HTML/CSV/Excel/XML with one click
Customize templates and styles
Preview of requirements document generation

Requirements Validation and Verification

Requirements verification by test cases
Baseline Management
Create a regression test suite based on the requirements
Create a system test suite based on the requirements

Search, Custom Views and Personal Dashbaords

Strong filtering capabilities and dashboards
Inconsistency alerts and notifications
Filtering based on attributes and associated data types
Audit Design Basis
Strong search capabilities
Sort custom views
Save private/public custom views
Report on who is working on what requirements
Filter for a list of new/changed requirements and review the changes
Customize and view dashboard reports

Electronic Signature, Review And Audit

Track requirements approval/signoff
Request requirements approval/signoff via email
Report on whether a set of requirements have been reviewed (looked at)
Electronic signature according to 21 CFR part 11

Requirements Baseline And Version Management

Create baselines of the requirements using QPack TAG
Compare baselines of the requirements
Version control management
Freeze content (baseline)
Branching

Data Sharing And Permissions

Share information using emails, and instant messaging
Control the permissions based on the user role

Discussions And Instant Messaging

Manage discussions – capture the discussions related to the requirements within the System

History Log And Audit Trail

21 CFR part 11 compliance
Full history log for audit trail
Track conversations about requirements, attach conversations to requirement objects
Automatically maintain audit trail for requirement changes (user, time/date, annotation of change, and change detail)
Notify affected project participants by e-mail about requirement changes