computer-system-validation

50 URS + 50 paired FS for GxP-regulated computer systems. CC-BY-SA 4.0. Synthetic, AI-authored, not a regulated record.

Deterministic front-end validation with signable evidence: locked YAML protocols, raw screenshots, hash-chained audit trail, PDF execution records.

Life-sciences CSV & GxP toolkit for Claude Code — GAMP 5, 21 CFR Part 11, EU GMP Annex 11, the live eCFR & openFDA, and an IQ/OQ/PQ qualification engine. Slash commands, auto-invoked skills, parallel sub-agents, an MCP server, and a document-protection hook.

Excel-Based LIMS Development and Computer System Validation (CSV) project Following GAMP 5,

GxP-aware runtime: AI agents act on validated BioPharma systems through versioned action definitions, GAMP 5 risk, 21 CFR Part 11 e-signatures and ALCOA+ execution records

C-based validation-management system demonstrating requirements, testing, execution records, and end-to-end traceability for regulated software.

Interactive ISO 13485 quality desk on a synthetic plant: calibration sticker vs certificate, CAPA 8D, supplier SCARs, IQ/OQ/PQ.

Software validation and change control tracker: GAMP 5 risk-based validation, IQ/OQ/PQ, e-signatures and a hash-chained audit trail.

A minimal 21 CFR Part 11-compliant electronic case report form (MERN) with a full GAMP 5 computerized-system-validation package and automated OQ evidence.

Quality management for AI coding agents: quarantine, independent review, sign-off, change control, validation and CAPA, with a verifiable audit trail (GxP-inspired, ALCOA++, Part 11/Annex 11 crosswalk)