Paperless batch execution — reviewed by exception.
Built by life science experts to simplify electronic batch records.
“Batch release went from 5 days to 1. Review-by-exception is the single biggest unlock we’ve had in years.”
Improved traceability & automation
Replace manual coordination with structured, configurable workflows — with a full audit trail on every action.
Confident compliance
Designed to support FDA 21 CFR Part 11, EU GMP Annex 11 and ISO 13485 — inspection-ready by default.
Data-driven oversight
Monitor activity, backlogs and compliance KPIs in real time so leadership has the visibility it needs.
Faster implementation
Go live in weeks — not quarters — with structured rollout, training and 24/7 support.
From day one — every step controlled.
Master batch record design
- Author MBRs from controlled templates
- Embed in-process checks and limits
- Link operations to SOPs and qualified roles
- Version-control with full change history
Execution at the line
- Guide operators step-by-step on tablets
- Block out-of-sequence or unqualified actions
- Capture e-signatures inline
- Surface exceptions for QA in real time
Review by exception
- QA reviews only the exceptions, not every page
- Investigate and disposition deviations inline
- Release batches faster with less rework
- Maintain a fully signed batch record
Equipment & material integration
- Capture equipment status and clean-state
- Verify dispensed materials against the MBR
- Auto-fill from LIMS and instruments
- Reconcile yield and balance
Everything E-BMR ships with.
MBR designer
Drag-and-drop authoring with embedded logic.
Review-by-exception
Surface only the exceptions to QA — not every check.
Inline e-signature
21 CFR Part 11 e-signatures at the point of action.
Equipment & LIMS hooks
Pull live equipment and lab data into the record.
Right-first-time
Enforce sequence, qualification and in-process limits.
Batch release pack
Generate signed release packs in a click.
Designed to support the standards you’re audited against.
See E-BMR on your own data.
Bring a real scenario from your operations — we’ll show you exactly how Electronic Batch Records handles it.