Problem solved · Quality intelligence

Untraceable deviations become structured root-cause data.

Free-text deviation forms can’t be analysed. V5 captures the deviation as structured data the moment it happens.

Start free — no card
Signals from the floor

What changes once Structured deviation & CAPA capture is live.

Indicative ranges from V5 pilot deployments. Your numbers will land near these once the workflow is operator-led and e-signed at the step.

Deviation rate
7.2%
down from 7.2% on paper
Avg. CAPA close time
62 days
down from 62
Open deviations >30d
100
auto-escalated at SLA
Repeat-cause CAPAs
38%
down from 38% — root cause sticks
Before / after

What changes the day you switch this on.

Before V5
  • Records reconciled and re-typed at end-of-batch.
  • Operators jump between paper SOPs, scales and a back-office PC.
  • Manual, paper-driven, and only audited after the fact.
With V5
  • Auto-opened from the kiosk
  • Linked to lot, operator, equipment, step
  • Closed-loop CAPA workflow

What you actually get

Operator-led, e-signed, immutable. Engineered for regulated manufacturers — not retrofitted.

Auto-opened from the kiosk

An out-of-tolerance reading opens the deviation while context is still on the operator’s screen.

Linked to lot, operator, equipment, step

CAPA analytics can finally answer ‘which line / which shift / which SKU is recurring’.

Closed-loop CAPA workflow

Effectiveness checks are scheduled, not assumed. Repeat findings get caught early.

What this leaves behind

One operator action — a complete, signed record.

Built-in evidence

What it leaves behind

  • Structured root-cause taxonomy
  • CAPA effectiveness scheduling
  • Trend reports per area
Engineered on
21 CFR Part 11 e-signatures
Immutable audit trail
Multi-tenant RLS isolation
GS1-128 license plates
Two-way ERP adapters
Common questions

What buyers ask before they switch on Untraceable deviations become structured root-cause data..

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.