Individual case processing time down 65%, regulatory deadline breaches down to zero

Adverse event information came in from physician phone calls, email, literature and social media. The pharmacovigilance team entered, coded and assessed causality for each case by hand, then submitted within statutory deadlines. Volumes grew every year, and the risk of late submissions became a focus of compliance audits.

The company wanted overdue cases eliminated without adding staff, with every step traceable.

Within the pharmacovigilance SOP framework, we launched an individual case processing Agent. People keep medical judgment and sign-off; the Agent handles collation, coding and checks.

• Multi-channel information is structured automatically into a draft individual case safety report, with a follow-up question list generated for any missing data
• MedDRA coding suggestions and WHO-DD drug matching, with candidate evidence attached for the pharmacovigilance specialist to confirm
• Deadline calculation and alerts: the statutory submission deadline is computed automatically by report type, with early warnings
• A literature monitoring Agent scans databases daily, and suspected cases enter the processing queue automatically

The system is deployed on the corporate intranet and went through computerized system validation. Every generated output and every manual edit leaves an audit trail, meeting GVP traceability requirements. The model never sees patient-identifying information.