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Requirements Management Software 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)
- Generate specs to MSWord/Excel
- 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.
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
Create baselines of the requirements using QPack TAG
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
