V5 Ultimate
Module · eBMR / eDHR

eBMR / eDHRthe batch record writes itself.

When the master is locked and the operator works on the kiosk, the batch record is no longer something to assemble — it’s something to render.

Start free — no card
Watch the batch record write itself

The record IS the work — not paperwork at the end.

Scroll. Every step that lights up here is exactly what the operator did on the floor — signed, timestamped, bound to the equipment and the SOP version that was effective at that moment.

Electronic Batch Record
B-78214 · live
—:—
Header
WO-78214 · Lot B-78214 · MMR v6.2 (effective)
—:—
01 · Line clearance
Suite 2 / Bay 3 · prior lot purged
—:—
02 · Dispense — Lactose mono
lot L-9921 · scale SC-12 (cal ok)
value0.000 kg·target 18.40 ± 0.05 kg
—:—
03 · Dispense — API X
lot AX-4471 · two-of-two witness
value0.000 kg·target 2.00 ± 0.005 kg
—:—
04 · Granulation start
GR-2 · charge order verified
—:—
05 · In-process moisture
MOI-04 (cal due 18 d) · 3 reads averaged
value0.000 kg·target ≤ 2.0 % LOD
—:—
↳ Deviation D-1184
1st read 2.14 % — second sample taken, root cause: probe contact. Attached inline. QA notified.
—:—
06 · Blend
BL-1 · 14 min @ 12 rpm
—:—
07 · Compression — sample QC
AQL Level II · pass route
—:—
08 · Yield reconciliation
97.4 % · within band 96–102 %
—:—
Seal
Review-by-exception complete · 1 exception resolved
Awaiting final step
sha256: · rendition → ERP MIGO posted · archive WORM
exceptions: 1 resolved
review-by-exception: 1 step opened of 11
QA time: 4 min (vs 38 paper)
No re-typing. No back-of-binder corrections. No "the record vs what actually happened". The eBMR/eDHR is the live, signed, verifiable system of record — and QA only opens the steps that need attention.
21 CFR 211.188 · EU Annex 11 · ISO 13485 §4.2.5

The batch record writes itself.

Paper batch records get transcribed at end of shift, by tired operators, then chased through review for two weeks. V5's eBMR is assembled in real time at the kiosk — every scale reading, every scan, every electronic signature lands directly in the record at the moment it happens.

The record as it forms

You're watching a batch record build itself right now.

The entries fill the page as the floor works. No "I'll write it up after lunch." No transcription error. No missing signatures found 3 days later when QA reviews the file. The eBMR is the floor.

live · WO-2025-1184 · BATCH B-44871
eBMR · in flight
  1. ·Step 1 · Line clearance
  2. ·Step 2 · Dispense API
  3. ·Step 3 · Charge mixer
  4. ·Step 4 · Mix · 18 min @ 220 rpm
  5. ·Step 5 · In-process pH check
  6. ·Step 6 · Fill start
  7. ·Step 7 · Yield reconciled
Made-by · checked-by · witnessed-by

Every signature has a name, a why, and a witness.

Made by
M. Reyes · Operator II
10:18:04
"Charge mixer per MMR rev 7"
Witnessed by
L. Park · Senior Operator
10:18:11
"Co-present, observed charge"
Checked by
S. Aoki · QA Reviewer
10:42:38
"Step closed, no deviation"
Re-authentication enforced inline · Part 11 §11.200(a)(1) · password + role-bound user account
Deviation · the moment it happens

An out-of-spec reading opens a deviation before the operator's finger lifts.

Paper systems find deviations at review. By then the evidence is cold and the disposition is guesswork. V5 captures the deviation with the reading, the operator, the scale, the recipe step and the time — locked into the record before anyone moves on.

pH 6.21 · spec 6.5–7.5
→ deviation DEV-2025-0918 auto-opened
→ tag: in-process · severity: medium
→ owner: QA M.Aoki · due: 24h
→ batch holds at Step 5 · cannot advance
→ operator notified · supervisor paged
evidence captured · cannot be edited

QA closes the eBMR with two clicks.

Every signature already gathered. Every deviation already adjudicated. Every reading already in the chain. Release happens in the same minute, not the same fortnight.

eBMR B-44871 · SEALED
218 signatures · 1 deviation closed · 0 missing entries
hash 9a·2e·f1·…·44d8 · QA S.Aoki · 14:02:11Z

Right-first-time, by construction.

V5

Curious how the eBMR / eDHR actually builds itself?

Connected

The batch / device record is the single object every system writes to.

MES, QMS, document control, calibration, Part 11 audit, and ERP all bind to the same eBMR / eDHR. No re-typing into a separate batch record at release.

MES · kiosk
Every charge, weight, scan and e-sig writes directly to the eBMR step — no second system.
Document control
The MMR / DMR revision is pinned at WO release; the same version drives the kiosk and the rendered record.
Calibration
Instruments out of cal can't write to the batch record — the step blocks at the source.
The record
eBMR
eDHR
QMS · deviations
OOS, NCRs and CAPAs render at the step they came from — reviewer never juggles two systems.
21 CFR Part 11
E-sig, re-auth, meaning-of-signature, append-only audit trail — enforced at the database tier.
ERP
Sealed batch posts true consumption, true yield, and a PDF rendition link — at close, not at month-end.
One record. One signature surface. One archive.
Inspectors stop asking "is this the latest version?" — there is only one.
V5

Wondering how the eBMR / eDHR plugs into the rest of your stack?

Engineered on
21 CFR Part 11 e-signatures
Immutable audit trail
Multi-tenant RLS isolation
GS1-128 license plates
Two-way ERP adapters
Instead of an FAQ

Just ask V5 — it knows the product cold.

Pick a question or type your own. V5 answers grounded in how ebmr / edhr — self-building electronic batch records | v5 ultimate actually behaves on the floor.

Got questions, or want to see it on your shop floor?

Ask V5 — our code-aware assistant — or spin up a workspace. Both are free.