Module · Recall & traceability

Recallfrom notification to scoped report, in minutes not days.

Most QMS tools stop at the Issue Log. V5 owns the genealogy that makes a recall real: scan the suspect lot, V5 walks the BOM forward to every batch it touched and forward again to every shipment and customer, locks the affected stock to a Recall hold-bin, and produces the 21 CFR 7 / ISO 13485 §8.3-ready recall report with operator, customer and timestamp evidence sealed in.

Start free — no card
Signals from the floor

What changes once Recall management 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.

Time to first batch
90 days
validated, e-signed, live
Audit-ready records
0%
Part 11, immutable, queryable
Operator adoption
0%
kiosk-first, no training-week
Manual paperwork
100
eliminated at the step
Before / after

What changes the day you switch this on.

Before V5
  • Manual, paper-driven, and only audited after the fact.
  • Lot trace at the batch level — bag-level genealogy is guesswork.
  • Records reconciled and re-typed at end-of-batch.
  • Tribal knowledge in spreadsheets and shared drives.
With V5
  • Mock recall on a schedule
  • Scope-by-genealogy in seconds
  • Auto-hold the affected stock
  • Regulator-ready report package

What you actually get

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

Mock recall on a schedule

Run a documented mock recall from a finished-good lot, ingredient lot, or complaint — your annual recall drill becomes a button, not a project.

Scope-by-genealogy in seconds

V5 walks forwards through dispense → blend → fill → pack → ship and surfaces every affected batch, container, customer and shipment with quantities and dates.

Auto-hold the affected stock

Any on-hand quantity from impacted lots is moved to a Recall hold-bin and locked from picking, ship, or dispense until you release it.

Regulator-ready report package

One signed PDF: scope, root cause, customer notification list, mock-vs-actual flag, time-to-scope, operator e-signatures — versioned and immutable per Part 11.

What this leaves behind

One operator action — a complete, signed record.

Built-in evidence

What it leaves behind

  • Forward + backward genealogy walk
  • Auto-lock of affected stock
  • Mock recall drill on a schedule
  • Time-to-scope captured for the auditor
Regulatory anchor

The clauses this satisfies

21 CFR 7 (recalls)21 CFR 211.150 (distribution)21 CFR 820.200 (servicing) / §8.3 ISO 13485FSMA 204 KDE traceability
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 Recall.

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.