Quality & Validation (2025)

Olga Mierzwa-Sulima, Eric Nantz & Paulo Bargo

Validating Open Source Tools with Stochastic Components; Architectures to provision validated R packages

2025
Validation
Authors

Olga Mierzwa-Sulima

Eric Nantz

Paulo Bargo

Published

September 15, 2025

Quality & Validation

Chairs: Olga Mierzwa-Sulima, Eric Nantz and Paulo Bargo

See also: 2023 Discussion, 2024 Discussion

Shiny-Centric Validation Discussion

  • Dynamic Validation: Challenges validating Shiny apps with multiple inputs and dynamic UI changes
  • Cross-Language Validation: Interesting approach using different languages (e.g., SAS) to validate Shiny outputs
  • User-Centric Testing: Need for dynamic validation of user interactions beyond business logic validation

Package Validation Approaches

  • Environment Types: Companies building both exploratory and validated GXP environments
  • Validation Cycles: Range from every 6-12 months to agile approaches completing validation in hours
  • Speed vs. Compliance: Demonstration that speed and compliance can coexist with proper processes

Infrastructure Management

  • Container Strategy:
    • Managing multiple packages and images is challenging
    • Base images specific to projects or therapeutic areas recommended
    • Kubernetes as standard for container management
    • Container sizing remains technical challenge
  • Image Management: Need for structured approach to container proliferation

Package Transparency Benefits

  • Open Source Advantage: Unlike SAS, can see how bugs are identified and resolved
  • Visibility: Access to bug reports and fixes provides better understanding than closed-source alternatives
  • Internal Package Standards: Internal packages should follow same validation processes as external packages

Testing Standards and Practices

  • Separation of Roles: Testers should be different from developers
  • Validation Definitions: No industry standard for what “validated package” means - companies define their own criteria
  • Reproducibility: Focus on reproducible code as foundation for validation

GenAI Integration Challenges

  • Output Validation: GenAI outputs need reproducible code that can be tested and validated
  • Documentation Transparency: Suggestion to identify AI-generated documentation for additional scrutiny
  • AI-Assisted Review: Mixed opinions on using AI bots to evaluate tests - could be useful but may reduce human vigilance

Emerging Tools and Technologies

  • Testing Innovation: New automated testing tools with reporting and screenshots coming from vendors
  • ShinyTest Evolution: Improvements in Shiny testing capabilities
  • Teal vs. ShinyMeta: Teal’s approach to reproducible scripts gaining more adoption than ShinyMeta
  • DuckDB Integration: Promising for handling large data in Shiny applications without full database overhead

Backward Compatibility

  • R Perception vs. Reality: Addressing misconceptions about R’s backward compatibility
  • Documentation Needs: Importance of documenting package versioning and major changes