🔬 Telomara Sandbox Air-Gap Staging Mode
Pilot Auditor (demo_analyst)
STAGE 1

Select Regulatory Scope for Synthetic Review

Choose an industry scenario to package the synthetic execution document and QA verification matrix.

Deviation & CAPA

Bioburden excursion on purified water loop. Tests unexecuted signature & root-cause logic.

ISO 13485 / GMP

Manufacturing SOP

Bioreactor automated CIP procedure. Tests orphaned references & form mismatches.

ISO 9001 / Annex 1

Clinical Study Report

Phase 2 oncology efficacy endpoint. Tests statistical narrative vs summary table conflict.

ICH E3 Guideline

MDR Technical File

Class IIa GSPR checklist. Tests unreferenced conformity justifications.

EU MDR 2017/745
synthetic_capa_bioburden.pdf Target Analysis Document (Synthetic PDF)
rules_capa_iso13485.csv Standard Matrix Criteria (Verification Ruleset)