Quarantine & Release Software — How to Enforce Hold/Release Decisions in Regulated Warehouses (USA)

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated December 2025 • quarantine software, hold release enforcement, QA disposition workflows, lot status control, inventory blocking, audit trails • Regulated Manufacturing (USA)

Quarantine & release software is one of the highest-leverage controls in regulated manufacturing because it answers a brutally simple question: Can the system physically prevent bad or unapproved material from being used or shipped? If the answer is “no,” then your quality program is operating on policy and trust, not enforceable control.

Many companies think they have quarantine because they put red tags on pallets or add “HOLD” in a spreadsheet. That works until the day it doesn’t—usually during a rush order, a staffing gap, a busy dock, or a shift change. A real quarantine & release system is digital and enforceable: it controls lot status, blocks inventory actions, records decisions, ties evidence to approvals, and produces a defensible audit trail without heroics.

“If ‘hold’ doesn’t block, it isn’t a hold. It’s a note.”

1) What US buyers really mean by quarantine & release

When buyers ask for quarantine & release controls, they are usually trying to solve one (or more) of these operational risks:

• Quarantine escapes: held material still gets picked or consumed during busy periods.
• Inconsistent dispositions: different QA people handle similar situations differently.
• Slow release: inventory sits idle because COA/test review is manual and evidence is scattered.
• Supplier variability: COA mismatches or missing documentation create frequent holds.
• Audit pressure: inability to prove who released what and why, with evidence.

A mature quarantine program is not about holding more material. It’s about holding the right material, releasing fast when justified, and being able to prove that the system prevented unauthorized use while decisions were pending.

2) Define success: quarantine & release KPIs

3) What quarantine & release software must cover

At minimum, quarantine & release software must support:

• Lot status quarantine/hold/released/rejected/re-test required
• Location controls physical segregation logic via bin locations or zones
• Enforced blocking prevents pick, consume, ship actions on restricted lots
• Disposition workflows QA review and approval with required evidence
• Supplier document linkage COAs, specs, test results (COA)
• Deviation linkage quarantine driven by events (deviations)
• Audit evidence attributable decisions + audit trails + exports
• Traceability support lot genealogy and exposure impacts (lot genealogy)

If your “quarantine system” does not control the warehouse execution layer, it will fail under operational stress.

4) Lot status model: states, transitions, and rules

A strong quarantine system starts with a clear status model. These are common status states in regulated operations:

• Quarantine: material received but not yet approved for use.
• Hold: material restricted due to a quality event, investigation, or missing evidence.
• Released: approved for use/shipment under defined conditions.
• Rejected: not acceptable; must be returned, destroyed, or otherwise controlled.
• Re-test required: conditionally usable only after additional testing/verification.
• Expired/obsolete: not usable due to date or policy controls.

Status transitions should be governed. That means:

• Role-controlled authority: only authorized roles can release or reject (RBAC).
• Required evidence: COA, test results, inspection outcome, or deviation disposition must be attached.
• Audit trail: every transition is logged with who/when/why (audit trail).
• Reason-for-change: critical decisions require rationale, not blank approvals.

5) Disposition workflows: approve, reject, re-test, rework

Quarantine & release software should make disposition predictable. Common workflows include:

Software should also support partial release scenarios (e.g., split lots, partial pallets) while preserving traceability and preventing “leakage” of restricted material.

6) Enforcement: how systems actually block actions

Enforcement is the difference between a quarantine program and a quarantine wish. Your software should block:

• Picks: warehouse cannot pick held lots for orders.
• Moves: restricted lots cannot be moved into “released” zones without controlled transactions.
• Consumption: production cannot dispense or consume held lots.
• Shipments: shipments cannot be confirmed if restricted lots are included.

Blocking must occur at the execution layer (scanner screens, pick confirmation, weigh/dispense stations)—not just at reporting time.

7) Linkage to supplier quality, COAs, testing, and deviations

Quarantine and release decisions are only as good as the evidence behind them. Your system should link directly to:

• Supplier qualification and status (supplier qualification).
• COA verification and required fields (COA).
• Test results from LIMS or QA testing workflows (tests/laboratory analyses).
• Deviation records that drove a hold (deviation management).
• Traceability so release/hold decisions propagate to genealogy and exposure reporting.

8) The vendor demo script (copy/paste) + scorecard

Use the same demo script for every vendor. It forces proof of enforcement and evidence linkage.

9) Selection pitfalls (how quarantine fails in real warehouses)

• Holds that don’t block. If people can still pick, the system is not enforcing.
• Status changes without evidence. Releases must be justified and auditable.
• Too many statuses. Overcomplicated state models lead to misuse and confusion.
• No SLA/queue management. Holds age out and become normal, increasing risk and cost.
• Manual segregation only. Tags and tape are fine, but digital enforcement must back it up.
• Systems disagree. If ERP says released and WMS says hold, you’ve created permanent reconciliation risk.

10) How this maps to V5 by SG Systems Global

V5 supports enforceable quarantine and release by connecting inventory status controls to execution and governance workflows.

• Status enforcement in warehouse: V5 WMS supports lot status controls and blocking at warehouse execution points.
• Quality disposition governance: V5 QMS supports governed approvals, evidence capture, and audit-ready disposition records.
• Production consumption blocking: V5 MES supports lot verification and can block consumption of held materials.
• Integration layer: V5 Connect API supports structured exchange (API/CSV/XML) to ERPs and external systems.
• Platform overview: V5 solution overview.

11) Extended FAQ

Q1. What is the difference between quarantine and hold?
Quarantine is often the default “not yet approved” state after receiving. Hold is usually a restriction triggered by a quality event, missing evidence, or investigation. Both must be enforceable to be real controls.

Q2. Why do quarantine programs fail under pressure?
Because holds are treated as paperwork or tags, not enforced blocks. Under rush conditions, people bypass “soft controls.”

Q3. What evidence should be required to release a lot?
Typically COA verification, inspection outcomes, test results when applicable, and justification/approval for any exceptions—captured with audit trails.

Q4. Do we need WMS to enforce quarantine?
Usually yes. WMS is the execution layer for warehouse moves and picks. If quarantine is only in ERP or QMS screens, it may not block physical actions.

Q5. How does quarantine & release affect recall readiness?
It directly affects scope and credibility. If held lots can leak into production or shipping, genealogy becomes uncertain and recall scope expands.

Related Reading
• Status & Control: Hold/Release | Material Quarantine | Quarantine Status | Role-Based Access
• Supplier Evidence: COA | Supplier Qualification | Incoming Inspection | Laboratory Analyses
• Traceability + Proof: Lot Genealogy | Audit Trail | Deviation Management
• V5 Products: V5 Solution Overview | V5 WMS | V5 QMS | V5 MES | V5 Connect API