Right first time,
and closed fast when it isn't.
Two numbers decide a manufacturing quarter: how many batches go right the first time, and how long the rest take to close. Both are dominated by work that is clerical rather than technical, reconciling a record by eye, and assembling evidence for an investigation that a scientist could reason through in an afternoon.
At review
Ranges, calibration, training and lot status reconciled in one pass
At deviation
Evidence gathered before an investigator opens the file
At audit
Every step, claim and signature already in the trail
From the day's batches to a signed conclusion.
Every batch is reconciled against the master batch record before a reviewer opens it. The exceptions are the only pages anyone reads, and the one that matters carries straight through into the investigation that closes it.
liveOpen deviations
3
2 with a proposed cause
Batches in review
7
avg 9 s to first pass
Median days to close a deviation
Every batch in review is reconciled before a reviewer opens it. The next one down the list is batch 381.
Batch Record 381, 2000 L production bioreactor
MBR v4 · executed 11–24 Jun · 128 signed steps · 41 pages
Reviewed in …
Parameters vs recipe
Recipe ranges × recorded values
Equipment calibration
Equipment historian
Operator training
Training system
Material & consumable lots
Inventory · QC status, expiry
Exceptions: the only pages a reviewer needs to open
- PARAMDay 6 pH held at 7.19, recipe range 6.95–7.15Step 6.2 · 4 h 20 min above range
- PARAMHarvest titer 3.10 g/L against a 3.50 g/L lower limitRelease QA · deviation already raised
- EQUIPDO probe DO-4471 calibration expired 3 days into the runBRX-2000-07 · historian record
- MATERIALFeed lot FEED-M-2402 released, osmolality outside historical bandCoA on file · no restriction flag
The other 124 steps reconciled clean against the master batch record. The titer exception already carries a raised deviation, so the investigation opens with the evidence attached.
Harvest titer · last 8 batches
Batch 381 came in at 3.10 g/L
Raised at the point of record
Evidence gathered automatically · read-only, your data only
- 7 comparable runs, same recipe and scale
3.49 – 3.62 g/L · this run 3.10
Run data
- Bioreactor BRX-2000-07 calibration
In calibration, verified 12 days before the batch
Equipment historian
- Operator and verifier training
Both current on SOP-USP-014 at execution
Training system
- Feed media lot FEED-M-2402
Released, osmolality 318 vs 295–305 mOsm/kg historical
Inventory / CoA
Proposed cause, 6M category: Material
Feed media lot FEED-M-2402 ran 13 mOsm/kg above the historical band for this recipe.
A genuine alternative stays on the record rather than being argued away, Environment, the day-4 room excursion, overlaps the same window.
The cost you are already paying.
Review is page-turning
A reviewer checks a hundred-plus signed steps against the master batch record by eye, then checks equipment calibration, operator training and lot status in three other systems. The exceptions are a handful of lines; finding them consumes the entire review.
Problems surface late
An out-of-range parameter or an expired calibration is often found at review, days or weeks after the batch. By then the corrective options are narrower and more expensive than they were on the floor.
Investigations wait on evidence, not on thinking
Pulling comparable batches, calibration records, training currency and lot history, and formatting it so Quality will accept it, is most of the elapsed time in a deviation. The reasoning is the short part.
Every client audit rebuilds the same story
For a CDMO, each client wants the same traceability assembled again in their preferred shape. It is repeat work with no compounding return.
On the platform.
The record is reviewed, not read
Recorded parameters against recipe ranges, equipment calibration status, operator and verifier training currency, and material and consumable lot QC status and expiry, all computed and reconciled against the master batch record.
Deviations raised at the moment of record
An out-of-spec result is flagged when it is entered, not at review. The window in which you can still do something about it stays open.
Evidence assembled before anyone opens the file
Comparable runs, equipment history, training records and lot genealogy are gathered automatically, so the investigator starts at the analysis instead of the archaeology.
A cause proposed, a human deciding
It drafts a 6M cause map and a 5-Whys chain from that evidence, commits to the best-supported cause and keeps a genuine alternative live. A named reviewer confirms and signs, nothing concludes itself.
CAPA goes to the QMS you already run
No parallel quality workflow to validate, maintain and train people on. The investigation record is the artifact; your QMS stays the system of action.
Per-client, per-batch traceability
For CDMOs, each client's program sits behind its own access boundary on one platform, with a release story that holds up when their quality team walks in.
Related capabilities
Bring us the work you already know the answer to.
We would rather you judge the platform against a result you can already check than sit through a scripted tour.
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