Regulatory Change & Impact Analysis
The Problem: Regulatory Updates & Compliance Risks
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The impact analysis enables a convenient mapping of requirements from 2 standards or regulations. This helps to systematically analyze their differences (or similarities).
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The mapping creates comparison units which (usually) contain several requirements. These units are called impacts. Where the impact is evaluated with a status and a text.
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The change is a neutral description of the difference between the mapped requirements. An example of such a change can be: "can" changed to "shall"...
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The impact describes the effect on the QMS or the product. Hence, it describes the effect of the change. The effect of the change depends on the implemented system in place.
The Problem: Regulatory Updates & Compliance Risks
Without a structured approach, companies risk:
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Small changes are difficult to detect visually, leading to missed regulatory updates.
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Manual, spreadsheet-based tracking that is error-prone and inefficient.
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Unstructured change assessments, causing delays and rework.
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Inconsistent traceability between regulations and internal processes.
Our Service: Structured & Automated Change and Impact Analysis
Why Choose ColabON?
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5-10x faster regulatory change assessments through automation.
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Elimination of spreadsheet-based compliance tracking.
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Structured traceability between regulatory changes and internal QMS.
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Seamless integration with existing quality and compliance systems.
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.
Contact us today to schedule a demo or start your compliance transformation.
INDUSTRY
Our partners
"In our previous system, it took months to identify gaps in SOPs. The discovery took far longer than the actual closure."
Corporate Head of QA/RA
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Do you have any questions?
