Step 04 · Shop-floor execution

QC releaseyour reviewer sees only what failed.

By the time a batch reaches QC, every signed step has already rolled up. Your reviewer reviews-by-exception, signs, and releases — with the deviations and CAPAs already linked.

Start free — no card
Signals from the floor

What changes once QC review-by-exception & batch release 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.

Right-first-time release
0.0%
spec-bound, two-eyes signed
Avg. lot release time
60.0 hr
down from 2.5 days
OOS investigations open
24
all routed to CAPA, none silent
CoA send-out
0%
auto-rendered from snapshot
Before / after

What changes the day you switch this on.

Before V5
  • QA reviews every batch line-by-line — release queue keeps growing.
  • Manual, paper-driven, and only audited after the fact.
  • Tribal knowledge in spreadsheets and shared drives.
  • Wet-ink signatures collected hours after the work happened.
With V5
  • Review-by-exception queue
  • Deviation + CAPA built in
  • CoA from real data
  • Two-signature release

What you actually get

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

Review-by-exception queue

Pass-pass-pass batches are one click. Anything out-of-spec is highlighted with the failing data point.

Deviation + CAPA built in

Out-of-tolerance events open structured deviations linked to operator, equipment, lot and step.

CoA from real data

Customer CoAs are generated from the actual measured values — not retyped from a binder.

Two-signature release

Where 211.165 / 111.123 require it, the kiosk enforces second e-sig before status moves to Released.

What this leaves behind

One operator action — a complete, signed record.

Built-in evidence

What it leaves behind

  • CAPA backlog visible per area
  • Audit-trail entries on every status change
  • Auditor portal — read-only login per batch
Regulatory anchor

The clauses this satisfies

21 CFR 211.165 (release testing)21 CFR 111.123 (QC roles)ISO 13485 §8.3
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 QC release.

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.