Requirements Management Tool

Streamline product development, reduce bottlenecks, and improve compliance with industry standards.
Designed to fit medical device companies.

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Requirements Management for Medical Device Development

Streamline requirements tracking and traceability with an adaptive tool that offers everything you need, including:

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Central repository
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Part 11 support by Electronic signature
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Import/export to MS Word/Excel
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Multi-requirements types supported
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Requirements Validation & verification using the Orcanos Test management tool
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Full Audit trail and history log
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Baseline management for better design control

End-to-End Traceability

Experience thorough tracking across all ALM artifacts using our powerful built-in traceability tool. Traceability seamlessly connects requirements to test cases and their results. The tool goes beyond to cover quality management, including FMEA for Risks, CAPA, and customer complaints.

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Online Document Review For Better Collaboration

Document collaboration allows 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

Navigating through baselines, versions, and changes between iterations poses a significant challenge in the development life cycle. Orcanos offers complete automation of version management and baselines, providing real-time visibility into changes made in each version.

Streamline product development processes. Contact us for more.

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Additional Features

Snapshots (Tags)

Capture data snapshots at key events, such as the completion of the review process, and compare them with previous snapshots to identify and assess the impact of changes.

Impact Analysis

Identify items as suspicious when linked work items undergo modifications, and promptly inform stakeholders of the change along with the reasons for the modification.

Freeze Content

Ensure the integrity of your design artifacts with our feature Prevent unauthorized changes, control access, and enjoy enhanced collaboration

Traceability To Risk

Trace requiremetns to risk for mitigaiton.

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