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. -
Limited scalability:
Every change restarts the discussion from scratch—making growth more difficult. -
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Frequent small and large changes in processes and requirements quickly render document-based tables outdated.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.
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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.
