QPACK REQUIREMENTS MANAGEMENT

QPack Requirements management tool is a robust solution for tracking your requirements and provide end-to-end product delivery solution. QPack Requirements Management is designed to meet your organizational needs, whether you are a small startup or a big enterprise. Using QPack as your central hub for the entire development lifecycle, assures that you can achieve the followings:

  • Single repository for requirements tracing and validation
  • QPack collaborative Tools to share thoughts with your team
  • Distributed development environment support
  • Medical Device compliance
  • Part 11 compliance with audit trail and electronic signature
  • Real-time dashboards, alerts and notifications – keep everyone in sync
  • Work in your native Office environment

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Requirements management for medical device

QPack Medical requirements management is a perfect fit for medical device manufacturers in that is supports what is required by medical device manufacturers:

  • Center requirements management database
  • Electronic signatures
  • Full Requirements Tractability matrix
  • 1-click generation of all requirements documents with traceability reports, such as SRS, SysRS, HRS, MRS….
  • Risk Mitigation – traceability between requirements and Risk work items
  • Manage multiple types of requirements
  • Requirements verification using test case traceability, including test results report generated automatically
  • Freeze content
  • Full audit trail and history log
  • Permission based system

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End-to-End Traceability

QPack ALM traceability matrix tool helps companies track coverage and traceability between any ALM artifact, such as system requirements, hardware and software requirements, test cases (QPack Test management), defects, risk, etc.

QPack Traceability Matrix supports the integration of QPack ALM to other QPack modules for medical device, such as QPack FMEA for risk management, CAPA and Customer Service for customer complaints, thus satisfying medical device regulation compliance and assure product quality.

QPack traceability tools assist in better tracking of change impact, using filters and real time alerts and notifications.

QPack provides visual reports of missing relations and quality deficiencies, such as failed tests, risks without mitigation, and more, using QPack smart dashboards.

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Online Document for better collaboration

The ability to collaborate directly from a web application. It enables several users to access the same document online and apply changes on the documents while preserving document integrity and data security.

 

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MSWord Document Generator

Use QPack DocGen, Orcanos unique document generator tool (DocGen) in order to easily design and generate MS Word documents including embedded reports.

This utility is most significant for medical device manufacturers as it allows generating documents ready to submission from QPack database, with just one click.

  • Generate your requirements documents such as Product and System Requirements, Software Requirements, Mechanical and Hardware Requirements documents and more
  • Software requirements Documents are submitted to any regulation or compliance
  • Synchronize changes in requirements between MS Word and QPack requirements management repository
  • Embed dynamic data in generated documents, such as reqirements traceability matrix, charts, FMEA table and more

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Hierarchic Requirements Management System

QPack provides both desktop and web-based Requirements management interface, allow you to create hierarchical trees of requirements in QPack portal with a Word Editor Interface, or HTML.

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

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Office Integration

The only Requirements Management tool with embedded Word editor inside!

QPack Requirements Management system is seamlessly integrated with Microsoft-Word. In other words, you can create content such as system requirements document, or detailed design in Microsoft-Word and synch it with QPack requirements tree.

QPack MS Word Integration Plug-in allows users to stay in the environment where they are most comfortable and where they work on a daily basis.

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Collaboration

Working in QPack collaborative environment helps organizations to share information easily, by using several tools such as:

  • Email based messaging
  • Instant messaging
  • alerts and notifications.
  • Online document
  • Powerful user profiles management

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Requirements Management and ALM

While managing all project information in one repository, you can add traceability to QPack te4st management, QPack FMEA risk management, Detail design artifacts and more, thus track requirements verification by QA team and measure quality better.

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