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Regulatory Change & Impact Analysis

The Problem: Regulatory Updates & Compliance Risks​

Without a structured approach, companies risk:

  • Missed regulatory changes.

  • Manual, spreadsheet-based tracking that is error-prone and inefficient.

  • Unstructured change assessments, causing delays and rework.

  • Inconsistent traceability between regulations and internal processes.

Our Service: : Structured & Automated Change and Impact Analysis 

#1

Data Provision of Both Data Sets

High Quality Data Import

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No more copy past mistakes!

#3

Neutral Change Assessement

With automated text comparisons to highlight changes.

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No more lost details. 

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#2

Data Mapping: Old - New

Data Mapping with Statistics

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No more lost data

#4

Optional: Preliminary Impact Assessment Traceability & Data Linking

We assess how the regulatory changes affect your quality management system, or other requirements. Our structured methodology ensures a comprehensive evaluation.

We establish direct traceability between the new regulatory requirements and your internal processes. This ensures a clear audit trail and facilitates compliance reviews.

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Why Choose ColabON?

  • 5-10x faster regulatory change assessments through automation.

  • Elimination of spreadsheet-based compliance tracking.

  • Structured traceability between regulatory changes and internal QMS.

  • Seamless integration with existing quality and compliance systems.

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Which Impact Analysis do you need? 

Let's do a pilot with a fist impact analysis! 

Regulatory changes don’t have to be overwhelming. Let ColabON handle your impact analysis with precision and efficiency.

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Contact us today to schedule a demo or start your compliance transformation.

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© 2023 ColabON

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ColabON AG founded 2020

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