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Requirements Management Tool

Reduce your Manual Traceability cost spend

Requirements Management Tools
gohnson & gohnson
Mazor Robotics
Zimmer
ApiFix
Biosense Webster
Fio Corporation

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
FMEA Risk Management

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.

End To End Traceability
Agile Requirements Management Tools

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

MSWord Document Generator

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

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

Orcanos

Contact

8 Tozeret Ha'aretz Street
Tel Aviv, Israel
+972-3-5372561
info@orcanos.com

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