nydok is a combined specification writing and testing framework, for producing consistent and traceable specification documents.
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May 14, 2025 - Python
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gamp5
Here are 4 public repositories matching this topic...
Production-grade input/output firewall for agentic AI. Cryptographic audit trail on every tool call and model output. 21 CFR Part 11 and SOC 2 aligned.
python compliance gradio deterministic agents qms ai-safety audit-trail gxp pydantic fastapi llm gamp5 enterprise-ai hallucination-detection agentic-ai tool-calling llm-governance 21-cfr-part-11
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May 13, 2026 - Python
Validated DESeq2 RNA-Seq pipeline with full CSV lifecycle (URS, IQ/OQ/PQ), 21 CFR Part 11 and ALCOA+ compliance mappings, and GAMP 5 documentation.
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May 25, 2026 - R
50 URS + 50 paired FS for GxP-regulated computer systems. CC-BY-SA 4.0. Synthetic, AI-authored, not a regulated record.
csv pharma data-integrity biotech gxp urs synthetic-dataset regulatory-compliance gamp5 eu-ai-act computer-system-validation 21-cfr-part-11 alcoa-plus functional-specification eu-gmp-annex-11
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May 16, 2026
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