The pharmaceutical industry is embracing open-source tools like R for their flexibility and innovation in clinical data analysis. However, ensuring compliance with regulatory standards requires a robust validation strategy. This guide outlines the essentials of R package validation, covering both software-based and risk-based approaches. It highlights key aspects like GxP compliance, accuracy, reproducibility, and traceability, and explores industry tools such as {riskmetric} for effective risk assessment. The post includes a real-world example of Novo Nordisk’s successful R-based submission to the FDA, setting a precedent for the industry.
For the full guide, read the complete post on the Appsilon blog.
This summary is shared with permission from the original publication.
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