eBMR — Electronic Batch Record
The batch record that cannot be back-dated, skipped or signed by the wrong person
DeepEBMR replaces the paper BMR and BPR with the same document your QA already approved, executed on screen. Steps run in sequence, signatures carry meaning, and every entry lands in an audit trail that records not only what changed but why. It is the module that turns an ERP into a GMP system.
What eBMR — Electronic Batch Record covers
The record
- BMR and BPR in the electronic format of your approved BMR and MFR
- Template versioning, so a batch always executes the version in force on its date
- Real-time data entry at the point of performance, not transcribed at shift end
- Compiled, paginated batch record output for review and inspection
Control during execution
- Stage-wise gating — a step cannot start before the prior step is signed
- Line clearance as a signed checklist before the batch begins
- Dispensing with target, actual and tolerance, verified by a second person
- In-process checks against specification with automatic out-of-limit flagging
- Instrument and equipment binding, with out-of-calibration devices refused
Signature and trail
- Electronic signature with meaning, intent and re-authentication at the point of signing
- Dual signature on critical steps — performed by and verified by
- Immutable, server-timestamped audit trail of every parameter entered
- Review by exception, so QA reviews the flagged steps rather than every page
Integration
- Dispensing and yield post material movements into the ERP as they happen
- Deviations raised inline from a failed step and carried into QMS
- Batch disposition drives the stock move from quarantine to released
What the system notices for you
Suggestions only. Nothing here signs, approves or dispositions anything — a qualified person decides and the audit trail records who. Every model shows the data behind its suggestion, and every feature can be switched off per site.
Anomaly detection during execution
Watches parameters against the historical distribution for that product and warns while the batch is still running, not at review.
Review-by-exception assistance
Ranks flagged steps by likely significance so a reviewer starts with what matters.
Deviation drafting
Proposes a first draft of the deviation record from the step context, for the investigator to correct rather than compose.
Equipment this module connects to
Read-only by default, validated as part of the system, and buffered locally so a network drop never loses a reading.
| Weighing balances | Dispensing weight captured from the balance, so the number cannot be typed. |
| Process equipment and PLC | Parameters read from the equipment where a validated interface exists. |
| Label and barcode printers | Status labels and container labels issued under control, with reprint approval. |
eBMR — Electronic Batch Record — common questions
Is DeepEBMR compliant with 21 CFR Part 11?
It is designed to meet it. Signatures require re-authentication at the point of signing, carry a stated meaning, and bind to the exact version of the record. The audit trail is append-only, records reason for change, and cannot be deleted by any role including system administrator. Compliance is ultimately a property of your validated implementation, which is why the validation pack is part of the delivery.
Can DeepEBMR run against SAP instead of your ERP?
Yes. It is a standalone application that integrates over REST APIs. Several plants run it alongside an existing ERP rather than replacing one.
What happens if the network drops mid-batch?
The shop-floor client holds the step locally and reconciles when connectivity returns. No entry is lost, and the audit trail records the actual time of performance from the server rather than the time of sync.
Works with
Every module shares one database, so nothing below is an integration — it is the same record seen from a different desk.
Quality Control — LIMS
Specifications, methods, worksheets, results and the certificate at the end
Read more QAQuality Assurance — QMS
Deviation, change, CAPA, complaint, audit and training in one system
Read more COCosting
What the batch actually cost, not what the standard said
Read more EQEquipment Maintenance
Calibration status that actually stops the batch
Read moreSee it on your own floor.
Two hours with your production and QA leads. We walk one product end to end and show you where it lands in the system — then you decide whether a gap study is worth it.