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 7 public repositories matching this topic...
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
KRISS 표준시 기준으로 폐쇄망 GMP 장비들의 NTP 시각 동기 상태를 실시간 감시·검증하는 시스템 (읽기 전용, 시각 미배포). FastAPI + React, GAMP5 V모델.
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Jun 22, 2026 - Python
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
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.
csv validation mcp qualification gamp pharma life-sciences regulatory openfda gxp gamp5 mcp-server claude-code ecfr computer-system-validation 21-cfr-part-11 claude-code-plugin claude-plugin iq-oq-pq eu-annex-11
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Jul 4, 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
Excel-Based LIMS Development and Computer System Validation (CSV) project Following GAMP 5,
csv validation lims pharma dataintegrity gamp5 computer-system-validation 21cfrpart11 iq-oq-pq euannex11 excel-vali validation-summary-report
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Jun 22, 2026
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