Guide · 12 min · 2026-08-28
Oral Solid Dosage (OSD) Batch Manufacturing: Paper BMR to Digital EBR Guide
Step-by-step roadmap to digitize tablet, capsule, and granulation BMRs into validated 21 CFR Part 11 electronic batch records (EBR).
1. The Operational Bottleneck of Paper Batch Manufacturing Records (BMR)
Oral Solid Dosage (OSD) plants producing tablets, hard gelatin capsules, and dry syrups handle high-speed production lines across dispensing, high-shear granulation, fluid bed drying, blending, compression, coating, and blistering. Paper BMR packs often exceed 80 pages per batch, causing physical storage clutter, missing witness sign-offs, and delayed QA release.
2. Step-Level Digital Execution in Novaqis BRM
Transitioning OSD plants to Novaqis BRM streamlines operations: • Dispensing Verification: Barcode verification of active ingredients and excipients with integrated weighing balance interfaces. • Compression & Coating Checks: Real-time logging of tablet weight variation, hardness, friability, disintegration time, and coating weight gain. • Electronic Line Clearance: Pre-start verification checklists ensuring no leftover tablets or foil packaging from previous batches.
3. Rapid Batch Release & QP Review-by-Exception
Automated exception flagging reduces batch review from 3 days to under 2 hours, accelerating product release to global markets while maintaining 100% data integrity.
Experience the Enterprise GxP Suite Live
Discover how Novaqis unifies Document Management (DMS), Quality Management (eQMS), Training (LMS), Laboratory Informatics (LIMS), Batch Records (BRM), and ERP on a single high-availability architecture.
