Requirements Management Tool

Reduce the cost spent on manual traceability

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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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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 succes.

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

Requirements Import And Export

Import data from Excel, XML
Export a subset of requirements based on a filter view applied

Requirements Management Tool