Set Up GxP R Project

Create an R project structure that meets GxP regulatory requirements for validated computing.

When to Use

• Starting an R analysis project in a regulated environment (pharma, biotech, medical devices)
• Setting up R for use in clinical trial analysis
• Creating a validated computing environment for regulatory submissions
• Implementing 21 CFR Part 11 or EU Annex 11 requirements

Inputs

• Required: Project scope and regulatory framework (FDA, EMA, or both)
• Required: R version and package versions to validate
• Required: Validation strategy (risk-based approach)
• Optional: Existing SOPs for computerized systems
• Optional: Quality management system integration requirements