# Use cases · Devia

> How pharma manufacturers use Devia for sterile fill-finish, biologics, OOS investigations and inspection readiness.

Source: https://devia.qa/use-cases

Use cases

# Where Devia makes the difference.

From the filling line to the QC lab, Devia helps quality teams investigate faster and prevent recurrence.

- 01 Sterile fill-finish Fill-weight and environmental excursions 45% faster root-cause identification Challenge Line stoppages and EM excursions trigger dozens of deviations per month, each investigated from scratch. With Devia Devia links alarms, EM data and past events to propose likely root causes within minutes of intake. DEV-2214 Fill-weight variance, Line 04 Likely root cause: seal wear on dosing pump P-4, as in DEV-2211.

- 02 Biologics Bioreactor process deviations 38% reduction in investigation time Challenge Complex parameter drifts span multiple systems and make investigations slow and inconsistent. With Devia Historian and MES data are pulled into one timeline, with similar batches surfaced automatically. DEV-3112 pH drift, bioreactor BR-2 Three similar batches found; the DO probe calibration had lapsed in each.

- 03 Quality control OOS / OOT lab investigations 52% faster OOS Phase I closure Challenge Lab results and manufacturing deviations live in separate systems, hiding recurring patterns. With Devia LIMS results are connected to the batch context so Phase I and II investigations move faster. OOS-0417 Assay out of specification, lot 24-0915 Phase I: no lab error found. Linked to manufacturing deviation DEV-2187.

- 04 Backlog Clearing overdue deviations 60% reduction in overdue deviations Challenge Open deviations pile up past their due dates, putting batch release and compliance at risk. With Devia Risk-based triage and drafted reports help QA teams prioritize and close the backlog. Queue 48 open, 11 past due Triaged by risk: three Major first; eight drafts ready for review.

- 05 CAPA Recurring issues and CAPA effectiveness 41% fewer recurring deviations Challenge The same deviations return because CAPAs address symptoms rather than causes. With Devia Trend detection flags recurrence early and tracks effectiveness checks through to closure. CAPA-1797-01 Effectiveness check The failure returned in DEV-2041: flagged for effectiveness re-review.

- 06 Inspections Audit and inspection readiness 70% less inspection prep time Challenge Preparing for FDA or EMA inspections means days of gathering records and trends. With Devia A complete Part 11 audit trail and ready-made trend reports are available on demand. Audit trail 2,418 entries, attributed and time-stamped Trend report ready: deviations by cause over the last 24 months.

## See how Devia fits your plant’s deviation workflow.