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Design Control

Design Control

Quality Management

Quality Management

Requirements Management Software for Medical Devices

Our medical requirements management tool is ideal for medical device manufacturers and provides a variety of essential quality-related features, including:

  • Central requirements management repository
  • Electronic signature (21 CFR Part 11 compliant)
  • Generate specs to MSWord/Excel - ready for submission
  • 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

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
  • Impact analysis
  • Real-time dashboards, alerts and notifications

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.


Risk Automation

Automate the entire risk management system, such as Risk Level calculation method, automatic setup of probability based on the Hazardous situation, and more.

Tailor Made Design Control

Use orcanos flexibility to design the system to support your processes by customizing work items, meta-data, traceability, access control, and more

Track Missing Traceability

Use Orcanos powerful filters mechanism to track missing traceability for key processes, such as risk without mitigations, requirements without test cases, etc.

Online Document Review For Better Collaboration

Orcanos Online Document enables document 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.


Baseline Management

There is a major challenge of tracking baselines, versions, and changes between versions. Orcanos completely automates the version management and shows in realtime what has changed in each version.

Orcanos baseline management compare tags

Snapshots (Tags)

Similar to source control, Orcanos allows you to create snapshots of your data at a specific point in time, and later on, compare 2 snapshots to identify changes in graphical view

Impact Analysis

Orcanos impact analysis marks suspicious items when their source has changed, and notify stakeholders about the suspicious changes

Freeze Content

Use the Freeze content option In order to avoid unauthorized changes to your design artifacts

Requirements Management Features List

  • 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
  • Embedded HTML editor

  • Automatically check requirements for spelling errors

  • 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
  • Export requirements to Word/PDF/HTML/CSV/Excel/XML with one click

  • Customize templates and styles

  • Preview of requirements document generation

  • 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

  • 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

  • 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
  • Create baselines of the requirements using QPack TAG

  • Compare baselines of the requirements

  • Version control management

  • Freeze content (baseline)

  • Branching

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

  • 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

  • Import data from Excel, XML

  • Export a subset of requirements based on a filter view applied


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