Recall software that runs a mock recall in under two hours.
V5 executes both mock and real recalls from a single dashboard — instant forward/backward genealogy from a lot number or a customer complaint, automated customer notification, effectiveness checks, and the FDA/health-authority reporting pack generated on demand.
What breaks without this.
Mock recall takes 4 days, not 4 hours
The auditor times you. You fail. Because the trace lives in spreadsheets that nobody has opened in six months.
Customer notification is a spreadsheet blast
No delivery confirmation, no response tracking, no evidence you actually reached the affected accounts.
Effectiveness check never closes
You send the notice, but you can't prove the product came back or was destroyed.
Records-by-execution. Compliance, by design.
One-click forward and backward genealogy
From lot → components, suppliers, equipment, operators, environmental data — and from lot → shipments, customers, sub-lots, downstream products.
Automated customer notification with delivery + response tracking
Email + portal notifications with read receipts, acknowledgement capture, and quantity-returned tracking against quantity-shipped.
Effectiveness check gated
The recall cannot close until returned + destroyed + reconciled quantities equal shipped quantities, with signed rationale for any gap.
Regulator reporting pack
FDA Reportable Food Registry, USDA FSIS, Health Canada, EU RASFF and MHRA formats generated from the same underlying record.
Mock recall scheduler with scorecard
Schedule quarterly / annual mock recalls, log elapsed time, capture the auditor's scorecard, trend across sites.
What to look for when you're buying.
Recall systems live in the reaction time. If mock and real recalls take longer than the regulator's clock, you're behind before you start.
Mock recall drill cadence
What it tests: Does the system enforce and record mock recalls at required cadence?
Why it matters: FSMA and 21 CFR 7 audit programs check this.
V5: Scheduled with SLA; misses raise a finding record.
One-up / one-down trace
What it tests: Can affected consignees be listed in minutes?
Why it matters: The clock is short.
V5: One-click consignee list per traceability lot.
Classification workflow
What it tests: Class I / II / III with rationale?
Why it matters: Class drives notification urgency.
V5: Classification workflow with rationale capture.
Regulator notification tracking
What it tests: Are notifications tracked per jurisdiction with due dates?
Why it matters: Missed notifications are separate findings.
V5: Per-jurisdiction task set with clock.
Effectiveness check
What it tests: Does the system verify quantity recovered vs distributed?
Why it matters: Effectiveness is the closure test.
V5: Recovered vs distributed reconciled with signed effectiveness.
Spreadsheet vs legacy QMS vs V5.
Recall approaches.
| Capability | Spreadsheet | Legacy QMS | V5 Ultimate |
|---|---|---|---|
| Mock recall time | Day+ | Hours | Minutes |
| Consignee list | Manual | Report | One click |
| Classification workflow | Ad-hoc | Static | Native with rationale |
| Effectiveness | Manual | Optional | Reconciled and signed |
The clauses, verbatim — and how V5 answers each.
Recall clauses.
Recall means a firm's removal or correction of a marketed product that FDA considers to be in violation of the laws...
V5: Recall workflow implements Part 7 process end-to-end.
Records must be provided within 24 hours...
V5: 24-hour clock is a one-click export.
Reports of corrections and removals...
V5: Device 806 reports generated in-system.
Field safety corrective actions...
V5: FSCA lifecycle supported.
Step by step on the floor.
Recall lifecycle.
- 1Trigger
Event opens recall
Complaint, OOS, deviation or external signal opens recall workflow.
- 2Scope
Consignees and quantities
Traceability engine computes affected consignees and quantities.
- 3Classify
Class assigned
Class I/II/III with rationale.
- 4Notify
Regulator & customers
Per-jurisdiction tasks with clocks.
- 5Recover
Quantities returned
Reconciled against distributed.
- 6Close
Effectiveness signed
Effectiveness recorded; CAPA raised if warranted.
The math, with the assumptions visible.
Recall ROI is measured in speed and in recovered fraction.
Consignee list time
Live linkage.
Recovered fraction
Time-to-notify shortens the window in trade.
Missed regulator notifications
Per-jurisdiction task set.
One avoided widened recall pays for the module many times over.
What changed on the floor.
Setting
A food manufacturer subject to FTL.
Before
Mock recall took 9 hours; real recall in prior year recovered 61%.
After
Mock recall 22 minutes; last real event recovered 87% within FDA-visible window.
Proof points
- Mock recall < 2 hours vs. industry average of 4 days
- Forward + backward genealogy from one screen
- Customer acknowledgement + return reconciliation tracked
- FDA RFR, USDA, RASFF export formats built in
Built to satisfy
- 21 CFR 7 (FDA recall guidelines)
- FSMA 204 (Food Traceability Rule)
- 21 CFR 806 (medical device corrections & removals)
- EU MDR Article 89 (field safety corrective actions)
- USDA FSIS Directive 8080.1 (recall procedures)
Related on V5
Frequently asked questions
How fast can V5 execute a mock recall?+
Under two hours end-to-end for a typical batch: trace, customer list, notification dispatch, acknowledgement tracking start. Auditors typically allot 4 hours and expect 24–48; V5 sites finish inside 2.
Does V5 handle FSMA 204 traceability?+
Yes — the underlying traceability engine captures Key Data Elements at Critical Tracking Events for FTL-listed foods and exports the sortable spreadsheet FDA requires within the 24-hour rule.
What about medical device field safety corrective actions?+
V5 handles 21 CFR 806 corrections and removals and EU MDR Article 89 FSCA notifications with the same recall engine — device serialisation and UDI are first-class.
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.