A large generics pharmaceutical manufacturer · QA Automation · OCR + AI · Review by Exception · 21 CFR Part 11
Large paper/PDF batch manufacturing records reviewed manually — time-consuming and error-prone across production sites.
Difficult to consistently apply QA review rules across batches and multiple production sites.
No structured, time-stamped evidence trail for QA decisions and exception approvals.
Manual processes created gaps in 21 CFR Part 11 compliance for electronic records.
OCR + AI extracts data from executed BMRs and automatically flags anomalies against the master batch record.
Admins build and activate/deactivate checklist rules per Master BMR — primary, secondary & tertiary parameters.
Authorized users validate OCR-extracted master content before activation, ensuring extraction accuracy.
RBAC with SSO, immutable audit logs, and electronic signatures — built for FDA-regulated environments.
Manual review time — QA focuses only on flagged exceptions.
Compliant — electronic signatures & immutable audit trails.
Deployment-ready — RBAC with SSO across facilities.
Automated anomaly detection with confidence scores.