An electronic batch manufacturing record (eBMR, often simply EBR) is the executed record of a single batch: the materials and quantities used, the equipment and rooms, each processing step, the critical process parameters recorded, in-process checks, yields, deviations and the signatures of the people who performed and verified each step.
Where a paper batch record is a printed copy of the master that operators fill in by hand, an eBMR guides operators through the approved steps in order, checks values against limits as they are entered, enforces verification and hold points, and produces a complete, legible record with its audit trail.
Why it matters in GMP
21 CFR 211.188 requires a batch production and control record for each batch, including each significant step and the identity of the people who performed and checked it. Paper batch records are a major source of good documentation practice errors — missed entries, illegible corrections, late signatures — and their review is slow. An eBMR prevents many of these errors at source.
- Run every batch from approved, version-locked master data.
- Stop out-of-sequence work with hold points and verification steps.
- Raise deviations the moment a parameter goes out of limit.
How Swat iQua Suite handles it
In Swat iQua Suite a batch is created only from a released production order and snapshots the exact approved product, formula, process and specification versions. Hold points block later steps, verification is a separate e-signed duty for a different person, an out-of-limit CPP reading raises a deviation, and a step will not start unless the operator is trained on its SOPs. Close is e-signed, with yield classified against the formula’s window, and the executed batch record PDF includes the full audit trail.