Risk-based validation demo applying FDA CSA concepts with Python, Playwright, and pytest: risk engine, ALCOA+ evidence checks, and a generated validation summary.
Canonical handoff contracts and a hash-verified verifier suite for the research scaffold evaluation apparatus. Regulated-industry data-integrity grammar (ALCOA+, 21 CFR Part 11) applied to AI workflow tooling.
AlcoaBase (ALC) is a 100% local, open-source Document & Knowledge Management System. It unites ALCOA+ data integrity with AI, featuring deterministic PDF protocol generation and automated report data processing, training-gated workflows, RAG, and automated Computer System Validation.
Implements ALCOA-compliant integrity, Ed25519 cryptographic signatures, and mandatory TTL. Features Context-Delta logic to minimize token bloat and latency in multi-agent workflows. A disciplined, vendor-neutral boundary for secure, time-bound, and auditable AI orchestration.
Compliance-first engineering reference and Python automation patterns for pharmaceutical cold chain temperature monitoring — FDA 21 CFR Part 11, EU GDP, ALCOA+ data integrity.
21 CFR Part 11 audit trail: hash-chained append-only log + Ed25519 e-signatures (ALCOA+)
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