Intelligent Traceability & Gap Analysis
Why are Requirements and Processes
treated as if they were independ?
The traceability and gap analysis
evaluates and connects a standard, guideline, or other regulatory document with process or product requirements.
Problems with traditional methods for traceability and gap analysis:
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📌 Lack of structure: Managing over 10,000 regulatory requirements leads to significant redundancies in processes and product requirements.
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📈 Limited scalability: Every change restarts the discussion from scratch—making growth more difficult.
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⏳ No automatic updates: Frequent small and large changes in processes and requirements quickly render document-based tables outdated.
The 4 Steps of traceability and gap analysis
Our Service: Structured & Automated Change and Impact Analysis
Why Choose ColabON?
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5–10x faster evaluation of regulatory requirements through structure and automation.
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Elimination of manual, Excel-based tracking.
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Structured traceability between regulatory requirements and:
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Version-controlled processes and templates
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Product requirements
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90% lower maintenance cost: Always up-to-date data – always up-to-date traceability.
Need traceability and gap analysis?
We deliver from as little as one analysis. But the system becomes truly powerful when used across multiple requirements.
Contact us today to schedule a demo or optimize your compliance strategy.
QMS Data Package
ColabON Intelligent Gap & Traceability Analysis
Your Quality Management System (QMS) is subject to over 10,000 regulatory requirements. ColabON's intelligence has clustered these requirements so you're faster for your Gap Analysis and Traceability.
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MDSAP for a harmonized approach to regulatory requirements in Australia, Brazil, Canada, Japan, and the US (with potential future inclusion of Switzerland).
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MDR or IVDR for medical devices and in vitro diagnostic medical devices in the European Union.
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SN EN ISO 13485 as a specific European standard.
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CFRs for the United States.
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ISO 14971 for risk management, a fundamental aspect of medical device development.
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ISO/IEC Guide 63 and ISO/TR 24971 to aid in understanding the complexities of the MDR.
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IEC 62366-1 for usability engineering.
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IEC 62304 for software-related requirements.
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ISO 20417 for labeling and information provided with medical devices.
