A batch record is issued from the currently approved master (MMR), which snapshots into the record at the moment of issue. Later revisions to the master do not silently rewrite batches already in flight — the version an operator runs is the version an auditor reads.
Electronic batch records, run on the floor.
Reflux is a manufacturing execution system for regulated makers. Issue a batch record from your approved master, walk it step by step on a tablet or scanner, dispense with a connected scale and witness, and hand QA a complete, review-ready record when the work is done.
Batches started · 14 days
per dayDisposition outcomes
QA starts with the answer, not the hunt.
The complete batch story is ready when production finishes. Review becomes a focused decision — not an investigation into missing paperwork, unclear handwriting, or stale instructions.
Batch BR-2043
Review readiness
Master
Materials
Execution
Review
24 / 24
Steps complete
6 / 6
Signatures present
2
Exceptions documented
The complete story, ready to review.
No paper chase between production and QA.
A batch, from issued to disposition.
Reflux is a real execution system: the operator works on a device, the record is written as the work happens, and every state change is a signed event on the same ledger.
- 1 Issue
- 2 Prepare the room
A line-clearance step is a first-class step type, not a checkbox on a page. It is four-eyes enforced at the device, and no subsequent step in the batch runs until it has been signed off by both people.
- 3 Execute the step
The operator opens the next structured step on the tablet or handheld: the instruction, the equipment it names, the material it consumes, the in-process check it demands. Any lapsed operator training or overdue instrument stops the step before it happens — not in review afterward.
- 4 Dispense with a witness
For a weighed dispense, a connected scale streams tare, gross, and net directly into the record. The operator dispenses; the witness verifies; unit conversion (kg-to-lb, L-to-mL, density-adjusted potency math) is exact and reviewable at the point of use.
- 5 Capture the exception where it happens
An off-spec observation opens against the exact step. The line keeps moving; quality gets the early warning and the context they need. There is no separate paper form, no "we will write it up later".
- 6 Review by exception, then dispose
When production finishes, QA opens a reviewer mode that surfaces the flagged steps first, with a "reviewed n of m" attestation frozen at disposition-sign time. Disposition is signed. The batch is released, quarantined, or rejected — with the full evidence pack ready to hand over.
A smoother path from issue to release.
Follow one batch and see where duplicate entry, paper handoffs, and late surprises fall away.
- 1Start from certaintyEveryone begins from the same approved process, with no late recipe surprises reaching the floor.
- 2Keep the line movingMaterial use and traceability are captured together, so the team can move on without a second round of entry.
- 3Protect accountability without the dragThe right people perform and verify the work without turning every step into a password interruption.
- 4Deal with exceptions while they are manageableQuality gets the context early, while production keeps moving and the record stays honest.
- 5Arrive at release readyQA receives the finished story and can spend its time on the disposition decision—not completeness checks.
Less friction on the floor. More confidence at release.
Run the right process, every time.
Give the floor confidence that today’s instructions are the approved ones, at the revision effective for the batch it is running — improvements move forward without disrupting work already underway.
MMR-011 · Vitamin C 500 mg
master recordAnswer a supplier issue in minutes.
Understand the impact of a suspect input quickly, contain the right product, and keep unaffected work moving. Forward traversal from a suspect received lot to every downstream shipment.
Genealogy · FG-0107
one queryGive QA its judgment time back.
Routine completeness stops consuming the review. Review-by-exception surfaces only the flagged steps, with a "reviewed n of m" attestation frozen at disposition-sign time.
Release gate · BR-2043
QA disposition-
Every batch matches its master
Improve the process without creating doubt about the work already in motion. Effectivity windows keep an approved master from issuing outside its intended dates.
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One gloved hand on the line
Keep operators focused on the work instead of juggling screens, signatures, and paper handoffs.
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Exceptions surface themselves
Keep the line moving while quality gets the early warning and context it needs to respond well.
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A record you can hand over
Meet the inspector with a clear story instead of a hurried reconstruction. Every batch exports a self-consistent, signed evidence pack an auditor can independently verify.
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The units reconcile themselves
Dispense in the unit on the container. The batch record keeps the conversion, the density it used, and the potency math, exact and reviewable.
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A rejected batch is not a dead end
Recover a rejected batch through a fresh, signed reprocessing record with genealogy back to the original, and escalate it to quality when it warrants one.
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The gate holds at the step
An overdue instrument, a lapsed operator qualification, or a room in the wrong state stops the step before it happens — not in review afterward. Line clearance is a first-class step type, four-eyes enforced.
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The equipment log writes itself
Every equipment or room state change on the shared registry becomes an e-logbook entry, so calibration and maintenance history is complete without anyone remembering to type it up.
The handoffs around the batch get easier too.
Reflux
The batch is ready to move forward.
Fluid QMS
Quality receives the batch context with the exception, shortening the path from issue to action.
Orbit
Production starts with usable stock and returns finished goods without another reconciliation.
Vapor LIMS
When testing gates release, the evidence and decision stay in the same flow.
Give release day back to QA.
Tell us where batch review slows down today. We will show you a cleaner path from approved process to released product.