From Paper to Validated Digital Batch Records: A Roadmap for Oral Solid Dose Plants

Summary

Electronic batch records reduce review time and deviations, but validation effort often stalls projects. This roadmap sequences an EBR rollout for OSD sites, from master data to computer software assurance.

Key takeaways

1. 01A phased rollout that starts with the highest-deviation processes
2. 02Applying computer software assurance to cut validation effort
3. 03Master data and recipe governance before go-live
4. 04Metrics to report to site leadership

Written for

• Plant heads
• IT/OT leads
• Validation managers