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Shiny in GxP: From rhino to a Validation File
The complete path for a clinical Shiny app: rhino structure, shinytest2 suites, secure backends, async patterns, and the validation evidence file that lets QA sign.
Topic
#validation
6 posts
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Risk-Based R Validation: Open Source Under Inspection
The R Validation Hub method, hands-on: risk dimensions, the public risk-assessment app, package qualification records, and what an inspector actually asks for when your stack is open source.
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Validation as a Release Gate: Building a GxP Governance Layer for Shiny at Kardigan
How I designed the governance and validation layer for ClinVista, an internal Shiny data-review platform — and why it survived the decision to replace the platform itself.
One Number That Explains Where Rule-Based Validation Stops
69.7% of oncology CORE rules port cleanly to a graph constraint language. The 30% that don't are exactly where the dangerous errors live.
SAS to R Migration in Clinical Programming: A Practical Field Guide
Why pharma is moving from SAS to R, what breaks in practice (procedures, XPT files, QC), and how to migrate a validated macro library without a rewrite.
#sas-to-r#pharmaverse#admiral#clinical-programming#xpt#validation
Double Programming Without the Duplication: AI-Generated QC Code
Independent QC re-programming costs 30–50% of clinical programming effort. An AI framework matched 97.1–100% of variables while keeping independence intact.