Electronic Batch Record System
A 21 CFR Part 11 compliant electronic batch record system tailored for SOFIE's radiopharmaceutical manufacturing operations — replacing paper-based workflows with real-time digital traceability across all 15 sites.
The Problem
As SOFIE scales to 15+ manufacturing sites and enters Phase 3 clinical trials, paper-based batch records create growing risk. Each radiopharmaceutical dose requires a complete chain of custody — from isotope receipt through synthesis, QC testing, and final release. Manual records slow this down and create audit exposure.
The Opportunity
A purpose-built EBR system for radiopharmaceutical production would accelerate batch release, reduce compliance risk, and give SOFIE a scalable foundation for its growing clinical and commercial operations.
Key Benefits
- Real-time batch record capture during production — no transcription errors
- Full 21 CFR Part 11 compliance: e-signatures, audit trails, access controls
- Integrated QC review and electronic release workflow
- Cross-site visibility — any site's batch status accessible centrally
- Regulatory submission-ready data export (eCTD compatible)
How It Would Work
The system would integrate with SOFIE's existing ELIXYS synthesizers and LIMS infrastructure, capturing production parameters automatically and presenting operators with a guided digital workflow. Batch release would flow from QC to pharmacist sign-off entirely within the system.