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Abstract

Risk-based computer system validation is a process many companies developed long before the August 2003 Guidance for Industry document on Part 11 Scope and Application was issued by the US Food and Drug Administration. The main differences between priorexisting risk models and this guidance is the emphasis on patient and product safety, product quality, and record integrity as required in the Part 11 Scope and Application Guidance. When computerized systems are used to collect data on which decisions are made on drug efficacy and patient safety or are used to control the quality of drug during a manufacturing process, the point of focus has to change. This article outlines a consistent and justifiable method for determining the risk of a computerized system with the emphasis on patient and product safety, product quality, and record integrity.

Keywords

Risk assessment Risk Management Part 11 ERES System validation

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References

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RAMP (Risk Assessment and Management Process): An Approach to Risk-Based Computer System Validation and Part 11 Compliance

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