Use cases
From the filling line to the QC lab, Devia helps quality teams investigate faster and prevent recurrence.
01Sterile fill-finish
45% faster root-cause identification
Line stoppages and EM excursions trigger dozens of deviations per month, each investigated from scratch.
Devia links alarms, EM data and past events to propose likely root causes within minutes of intake.
Likely root cause: seal wear on dosing pump P-4, as in DEV-2211.
02Biologics
38% reduction in investigation time
Complex parameter drifts span multiple systems and make investigations slow and inconsistent.
Historian and MES data are pulled into one timeline, with similar batches surfaced automatically.
Three similar batches found; the DO probe calibration had lapsed in each.
03Quality control
52% faster OOS Phase I closure
Lab results and manufacturing deviations live in separate systems, hiding recurring patterns.
LIMS results are connected to the batch context so Phase I and II investigations move faster.
Phase I: no lab error found. Linked to manufacturing deviation DEV-2187.
04Backlog
60% reduction in overdue deviations
Open deviations pile up past their due dates, putting batch release and compliance at risk.
Risk-based triage and drafted reports help QA teams prioritize and close the backlog.
Triaged by risk: three Major first; eight drafts ready for review.
05CAPA
41% fewer recurring deviations
The same deviations return because CAPAs address symptoms rather than causes.
Trend detection flags recurrence early and tracks effectiveness checks through to closure.
The failure returned in DEV-2041: flagged for effectiveness re-review.
06Inspections
70% less inspection prep time
Preparing for FDA or EMA inspections means days of gathering records and trends.
A complete Part 11 audit trail and ready-made trend reports are available on demand.
Trend report ready: deviations by cause over the last 24 months.