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Traceability Management Tool

Traceability matrix management across ALM and QMS artifacts with impact analysis and multi-level reporting.

Solution by Orcanos
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Overview

The Orcanos Traceability Management Tool is a traceability matrix solution that integrates with the Orcanos Requirements Management Tool and supports traceability across ALM (Application Lifecycle Management) and QMS (Quality Management System) artifacts. It is designed for end-users and stakeholders across departments who need to manage quality processes including requirements, test cases, FMEA risk items, customer complaints, and CAPA compliance.

The tool operates from a centralized repository, enabling collaborative work across multiple artifacts and documents, and supports tracking of product lifecycle progress alongside impact analysis for defined changes.

Core Traceability Features

  • Generation of traceability matrices across ALM and QMS artifacts
  • Detailed traceability matrix reports
  • Alerts for impact analysis and product inconsistency
  • Simple navigation between traced items
  • Multi-level traceability reports that highlight project status and associated risks

Collaboration and Impact Analysis

  • Supports collaborative work within a centralized repository to streamline workflow processes
  • Allows stakeholders from different departments to work together on multiple artifacts or documents
  • Tracks product lifecycle progress and conducts impact analysis for defined changes

Multi-Level Traceability Reporting

  • Generates multi-level traceability reports providing an overview of project status and associated risks
  • Tracks approved risk items from mitigation through to verification
  • Reports display relevant risks, linked mitigations, related test cases for verification, and their results (Pass or Fail)
  • Supports informed decision-making based on project progress data

Test Verification and Requirements Traceability

  • Facilitates linking of test cases to requirements for verification and validation purposes
  • Allows stakeholders to establish traceability links for verification or validation
  • Monitors requirements associated with failed test cases to support smooth product lifecycle progress

The Orcanos Traceability Management Tool is part of the broader Orcanos ALM and QMS platform, covering traceability between any ALM and QMS artifact types within a unified environment.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Quality Management System (QMS)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
BiotechMedical Devices
Development stage(s)
ClinicalPost-Market & RWEPreclinical / Pre-Market
Target user(s)
Research ScientistQA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11EU MDRISO 13485