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Quality Management
CAPA, audits, deviations, and predictive quality analytics.
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Forecast
Open CAPAs
27
Deviations (30d)
84
↓ 12%
Audits this quarter
9
Predicted quality index
A−
CAPA — active corrective actions
New CAPA
CAPA
Title
Severity
Owner
Status
Due
CAPA-0421
Eligibility verification gap at Site S-309
Major
M. Becker
In-progress
Aug 02
Open
CAPA-0418
ICF version mismatch — Mass General
Minor
A. Lee
Verification
Jul 24
Open
CAPA-0411
Temperature excursion — investigational product
Critical
R. Patel
Root cause
Jul 18
Open
Recent deviations
Visit window exceeded by 4 days
DEV-1284 · S-204 · Jul 09
Low
Lab sample mislabeling
DEV-1280 · S-412 · Jul 07
Med
Concomitant med not reported on time
DEV-1276 · S-118 · Jul 05
Low
Predictive quality analytics
3 sites projected to trigger quality threshold in 30d
Charité (Berlin), Site S-309 (Frankfurt), Site S-515 (Seoul). Recommend additional monitoring visit + targeted retraining.
Audit readiness score trending up 4 pts WoW
Deviation rate per 1,000 visits: 6.8 (industry avg 11.2)
Inspection success probability: 96%