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.
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.
What changes the day you switch this on.
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.
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.
Curious how this lands in your environment?
Where AI actually earns its place.
AI helps you scope faster once genealogy has already done the hard work — surfacing the shape of the exposure and drafting the report so the recall team spends its time on judgement calls, not formatting.
- 01
Scope summary in plain language
Once V5 walks the genealogy forward and backward, AI summarises the result — number of lots, customers, shipments and quantities affected — in a paragraph the recall coordinator can read aloud on the first call.
Turns a spreadsheet of affected lots into a briefing the team can act on immediately.
- 02
Mock recall drill report drafted
After a scheduled mock recall runs, AI drafts the time-to-scope narrative and highlights any step that took longer than the last drill, so the annual exercise produces a real improvement note, not just a pass/fail.
- 03
Customer notification draft
AI drafts the customer notification letter from the scoped shipment list — lot numbers, ship dates, quantities — leaving the root cause and instructions section for the recall lead to complete and approve.
- 04
Root-cause first-pass
Where the trigger was a complaint or deviation, AI links the recall record to related deviations and CAPAs on the same line and proposes a first-pass root cause statement for the recall report.
AI never triggers a recall, never decides what stock gets held, and never sends a customer notification — the genealogy walk, the hold, and the signed regulator-ready report all require a human recall lead's sign-off.
One operator action — a complete, signed record.
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
The clauses this satisfies
What buyers ask before they switch on Recall.
The rest of the platform this plugs into.
V5 isn't a bolt-on. Every module shares the same data, the same audit trail, the same operator. Pick where to look next.
MES
Operator-led execution: scan-gated dispense, step-by-step kiosk, equipment + scale integration, live yield. Built for regulated process & discrete manufacturing.
WMS
Receiving, putaway, transfers, cycle counts, picks, pack & ship — all lot-aware, bin-accurate, FEFO/FIFO-enforced and barcode-driven.
QMS
Built-in QMS: deviations, CAPA, supplier scorecards, in-process AQL, release-by-exception. Aligned with 21 CFR 211/820, ISO 13485 and 111.
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.