Catch batch deviations before they become investigations
Fermentile connects to your DCS historian and LIMS to classify parameter excursions, compare current batches against historical runs, and pre-populate deviation investigation reports — so your MSAT team spends hours on root cause, not days building spreadsheets.
Request a Pilot
Three data systems, one deviation, three days of manual correlation
When a bioreactor batch shows a dissolved oxygen excursion at hour 36, the investigation starts in DeltaV historian exports, continues in an Excel pivot table, branches into batch record PDFs from the last six comparable runs, and ends in a deviation report that took three days to write.
The lot is on hold. The CDMO sponsor is waiting for a root-cause summary. The regulatory agency expects a CAPA within 30 days. And the next batch started 18 hours ago.
- Root-cause analysis requires manual correlation across DCS historian, batch records, and LIMS data
- No baseline reference view to compare current batch against historical good batches
- Deviation classification is inconsistent — different engineers classify the same excursion differently
- CDMO sponsor deviation reports written manually — delay lot release by 2–4 days
- Audit packages assembled from four separate systems the week before a regulatory inspection
- No continuous process verification dashboard — CPV studies done quarterly by one analyst
What the platform produces
MSAT teams evaluate analytics tools by their outputs. Each capability maps to a specific investigation or compliance workflow.
Deviation Classifier
Automated classification of parameter excursions against site-specific SPC limits — logged the moment the trend line crosses the control boundary.
Batch Comparison Engine
Overlay any batch against its ten most comparable historical runs — see immediately where the current run diverges from the historical envelope.
Process Trend Monitor
Real-time parameter trend visualization across all active bioreactor runs, with SPC control limits and alert boundaries drawn from your site's historical batch population.
Root-Cause Workbench
Correlate a deviation event against upstream parameter trends, equipment state changes, and material lot transitions in a 4-hour pre-excursion window.
Audit Trail Builder
One-click assembly of a deviation investigation package with timestamped PDF output and electronic signature manifest, designed to support 21 CFR Part 11 electronic records requirements.
Fits into your existing data stack
Engineers do not change how they operate. Fermentile reads the data your DCS, LIMS, and MES already generate.
DeltaV Batch
SampleManager
Syncade
Built for the people running the process
You run CPV studies and deviation investigations across 12 active bioreactor batches
You spend Tuesday afternoons building Excel pivot tables from DCS exports to find out whether the agitation dip at hour 36 correlates with the media lot change from last week. Fermentile does that correlation in minutes and pre-populates the investigation record.
You are scaling from 50L to 500L and need to know which deviations from pilot predict commercial failure
Scale-up decisions depend on understanding which parameter excursions at pilot scale are process artifacts versus genuine quality signals. Fermentile's batch comparison view shows you where the 500L run departs from the pilot envelope — not just that it departs.
Your sponsors require deviation reports within 72 hours. You have 8 open investigations and 3 pending audits
The CDMO sponsor deviation report is a contractual obligation, not just internal documentation. Fermentile generates a formatted sponsor package from the investigation record automatically — your team reviews and approves rather than writing from scratch.
Start with one bioreactor run
A Fermentile pilot runs against a single process or batch family from your site. We connect to your existing data infrastructure, validate the deviation classification against your historical batch population, and deliver a working investigation workflow within 30 days. No new data entry. No infrastructure changes.