Materials and lots
What was used, from which lots, in what quantity.
Pharmaceutical guides
Electronic batch records
How electronic batch records replace paper, what they capture and how they connect to your ERP.
What an electronic batch record is
A batch record documents how a batch of product was made: materials and lots used, quantities, equipment, process steps, checks, deviations and who did what.
An electronic batch record (EBR) captures this in software rather than on paper. That reduces transcription errors, enforces the right sequence of steps and makes the record available for review as soon as the batch is complete.
EBR is often part of a manufacturing execution system (MES). The ERP supplies orders, materials and lots, and receives consumption, output and costs back, so stock and finance stay in step with the shop floor.
What an EBR should capture
The core content regulators and reviewers look for.
Process steps
Each step, in order, with results.
Who and when
Attributable entries with timestamps.
Checks and signatures
In-process checks and electronic sign-off.
Deviations
Exceptions recorded and investigated.
Yield and output
Actual output against expected.
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FAQ
Frequently asked questions
A digital record of how a batch was made, replacing paper batch manufacturing records.
Fewer errors, enforced process steps, faster review and release, and easier access to records for audits.
Usually EBR sits in an MES or specialist system that connects to the ERP. Business Central records production orders, lot consumption, output and cost.
Yes. As GxP records, they fall under computerised system expectations such as Annex 11.
Pharmaceutical and life sciences ERP
- Pharmaceutical ERP software
- Business Central for pharmaceutical businesses
- ERP for life sciences
- Medical device ERP
- Pharmaceutical wholesale software
- Pharmaceutical inventory management software
- How to choose a pharmaceutical ERP
- Batch traceability and recalls in Business Central
- What is LIMS?
- Pharmaceutical supply chain explained
- GAMP 5 explained
- Computer system validation
- Electronic batch records
- Annex 11 explained