In-trial
Quality IQ
Deviations · CAPAs · change controls · inspection readiness
Open deviations
47
across active programs
Critical / Major
3 / 18
4 in current view
CAPAs effective
89%
vs 12-month rolling average
Inspection readiness
84/100
weighted across sites + sponsor
Quality Agent · CAPA effectiveness prediction
Continuum predicts CAPA effectiveness from historical pattern + root-cause similarity. Flagged: CAPA-0286 visit-window deviation — root cause overlaps with 3 prior CAPAs that re-occurred within 90 days. Recommended escalation to broader site-training intervention.
Open deviations
CriticalDEV-2026-0342CSL-HEM-021S-1047CAPA-0287 · CAPA effective
IP storage temperature excursion 8h above 2-8°C range
MajorDEV-2026-0341CSL-IRD-031S-2034CAPA-0286 · CAPA in-progress
Visit window deviation — 12 patients enrolled outside ±7d window
MajorDEV-2026-0340CSL-IMM-203S-1112CAPA-0285 · CAPA approved
Eligibility violation — 2 subjects enrolled without meeting Hgb threshold
MinorDEV-2026-0339CSL-HAE-007S-3089CAPA-0284 · CAPA effective
ICF version control — older v2 used for 1 patient (correct v3 was current)