Orcanos requirements management tool simplifies tracking of your requirements. Flexible enough to serve SMBs and powerful enough for enterprises.
Using the User Requirement Specification (URS), one of 58 types of requirements can easily generate several input requirements documents. Input Requirements some often fall into three categories namely;
The documentation for each requirement often depends on the product and the organization. Although, almost all organization have functional requirement documentation or documentation that directly addresses design input requirements (DIR). Sometimes there are separate documents to capture specific requirements of the document such as a Mechanical Requirement Specification (MRS). Another example is the Electrical Requirement Specification (ERS) that are created within the sections or either the DIR or FRS documentation, Orcanos ALM system support over 58 different types of requirements and can be expended to more as needed.
Other requirements that deserve consideration are safety and regulatory requirement. We mustn’t forget the requirements for applicable risk management inputs.
Orcanos medical requirements management tool is a perfect fit for manufacturers of medical devices and will provide you with
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.
Orcanos Online Document enables documents collaboration. Multiple users can access the same document together, while preserving document integrity and data security.
Orcanos DocGen is used to generate documents from Orcanos electronic records repository. Supporting embedded reports, and customized templates.
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
Add/edit/del/query requirements in a single repository
Manage entire lifecycle
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
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
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
Cross-Project Linking capability.
Use baselines to track chnages
Identify missing links
Navigate upstream and downstream
Define link types
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
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
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)
Share information using emails, and instant messaging
Control the permissions based on the user role
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