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Guide

GxP Risk Assessment for Computerized Systems


Recent scrutiny by the FDA on data integrity has motivated modern life science companies to improve their compliance with FDA regulations. Oftentimes, IT and Quality personnel perform a risk assessment to assess if software should be validated. In this guide, we provide a framework to assess the compliance risk associated with a given computerized system.

This guide is helpful as you implement new computerized systems because:

  • Comprehensiveness - enumerates multiple viewpoints on risk and keeping a patient-centric perspective at the core. By considering the different facets of potential risk, you can make a more informed decision about validating a given system.
  • Data Driven - many assessments make recommendations based on hunches or opinions. This assessment provides a measurable framework for assessing the risk associated with a given computerized system. As you look to implement your findings, hard data is helpful in asserting your position.

If you seek further assistance, feel free to contact our domain experts at [email protected] to help assist you.


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