GxP Audit & Lifecycle Assistant
Audit GroundedSYS-MES-001Reasoning across MES PAS-X (Primary), Master IT SOP, LIMS Benchmark & Top 25 Audit Checklist
Hello! I am your GxP IT Audit & Lifecycle Intelligence Assistant for Novo Nordisk.
I reason across:
• Primary Evidence: Novo Life MES PAS-X Lifecycle Package (NL-MES-*)
• Governance SOP: NN Master IT System Lifecycle SOP (HACK-IT-SOP-001)
• Benchmark Reference: GxP LIMS Lifecycle Package (LIMS-LCP-001)
• Executable Audit: Top 25 Difficult-Auditor Questions (2026 XLSX)
Try asking: 'Run the GxP audit on PAS-X.' or 'Why did question 7 fail?'
Just now
AI Observability & Evidence
Provider Status:Offline Fallback
Model: anthropic/claude-3.5-sonnet
Multi-Agent Execution Pipeline
Supervisor AgentDecomposed intent & evaluated lifecycle scope
System Knowledge AgentRetrieved grounded chunks from 10 lifecycle docs
Compliance AgentEvaluated 15 rules from compliance_rules.json
Traceability AgentTraversed 50 URS requirements & 26 system risks
Release Gate EngineEvaluated G1-G6: Confirmed HOLD / DEFER
Recommendation AgentSynthesized corrective human-gated remediation
Primary Grounding Evidence
NL-MES-ITPSE-001.docxPage 1
Section: Overall Conclusion & Recommendation
NL-MES-IREP-001.docxPage 3
Section: Lifecycle Phase Gate Status (G1-G6)
NL-MES-URS-001.docxPage 2
Section: Document Approvals & Signatures