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M Manufacturing · Batch records New

The batch record that writes itself.

Release day should not start with a records hunt. Batches run against an approved master and capture every lot, signature, reading, and deviation as the work happens, so the record reaches QA already complete. Review the exceptions, sign, release.

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AR
Good morning, Ana
Riverside plant · 12 July
Line 2 running
Batches in progress
6
+2 today
Awaiting QA
3
1 aging
Released · 7 days
11
0 rejected
Open exceptions
2
1 new

Batches started · 14 days

per day

Disposition outcomes

96%
released
Released
Rejected
Why electronic batch records

Paper batch records fail at the worst possible moment: the audit.

Approve the master once. Every batch is issued as an exact copy of it and fills in as the work happens: lots dispensed, steps performed and verified, readings, deviations, yield. By the time it reaches QA there is nothing left to chase down. The review is a read, not a reconstruction.

On the floor

Follow a batch from issue to release.

Scroll one batch through. Every screen is the product.

mfg.dlbd.us/batches/BR-2043
Search batches, masters, lots…
AR
Batch · Vitamin C 500 mg tablets
BR-2043In progress
MMR-011 · v3.1
issued 07:58
MMR-011 v3.1Approved 02 Jul · signed
Effective
Snapshot frozen into BR-2043exact copy
24 steps · 6 dispenses · yield 98–102%0 of 24 done
A later revision of the master can never reach this batch
  1. 1
    Issue the batch
    BR-2043 is stamped from master v3.1 as an exact, frozen copy. Later revisions cannot touch it.
  2. 2
    Dispense by scan
    Scan the lot, weigh it, and a witness signs. The debit and the genealogy link land in one transaction.
  3. 3
    Perform and verify
    Steps run in enforced order. The performer signs, a second person verifies, no password mid-run.
  4. 4
    An exception, on the record
    A reading lands out of tolerance. The line keeps moving; the exception waits for QA at review.
  5. 5
    Release with one signature
    The gate has checked steps, dispenses, exceptions, and yield. QA signs; the record locks, a PDF copy freezes.
Capabilities

From approved recipe to released batch, on one record.

Master records

Approve the recipe once. It stays approved.

A master is approved with a password and a reason, then frozen. Revising it creates the next version and supersedes the old one, so no batch ever runs against a draft or a stale copy.

MMR-011 · Vitamin C 500 mg

master record
v3.1Approved 02 Jul · password + reason
Effective
v3.0Retired by v3.1
Superseded
Batches issue from the effective version only. Drafts cannot run.
Genealogy

Any batch, traced to every input.

Dispensing debits the lot and writes the genealogy link in the same transaction. When a supplier calls about a suspect lot, the batches it touched are one query, not an afternoon of binder archaeology.

Genealogy · FG-0107

one query
LOT-01042
Ascorbic acid
5.002 kg
LOT-00988
Microcrystalline cellulose
4.10 kg
BR-2043 → FG-0107
Finished good · minted on the same lot graph
Released
The recall question is answered in minutes, with quantities
Disposition

The gate does the arithmetic. QA does the judgment.

The release gate has already checked step completion, dispense tolerances, exceptions, and yield. What lands on the QA desk is the part that needs a human: each exception, with who, what, and why attached. Sign to release, and a hashed PDF copy freezes with the record.

Release gate · BR-2043

QA disposition
Steps performed & verified24 / 24
Dispenses within tolerance6 / 6
Exceptions reviewed1 / 1
Yield 98.4%in range
Release batch
Password + reason · record hashed · PDF copy frozen
  • Every batch matches its master

    Issuing a batch freezes the full master into it. A recipe revision can never reach back into a batch already on the floor.

  • One gloved hand on the line

    Steps run in enforced order, performer and verifier sign as they go, and dispensing is a scan. No password prompts mid-run.

  • Exceptions surface themselves

    An out-of-tolerance reading or a missed yield raises an exception on its own. The line keeps moving, and QA sees everything at review.

  • A record you can hand over

    Signatures carry name, time, and meaning. The released record is hashed, with a frozen PDF copy an inspector can take away.

Composes with the suite

Runs beside quality, the warehouse, and the lab.

Fluid QMS

A batch exception escalates into a deviation and CAPA without retyping a word.

Warehouse & Dispatch

Dispense from released stock only. Finished goods land on the ledger, ready to ship.

Vapor LIMS

Run both and release can wait on the lab: finished-goods testing gates the disposition.

1
approved master, frozen and versioned
0
passwords to perform or verify a step
four-eyes, witnessed
Every
lot dispensed, linked to the batch it made
genealogy graph

Retire the paper batch record.

Batch records run standalone, or beside quality and the lab on the same login. Tell us what you make and we will set up a master recipe to walk through.