Situation
A warehouse management system introduces mobile scanning and offline picking for a regulated-material warehouse.
Intended Use
Verify material and location, enforce approved inventory status, record movement, and reconcile transactions to ERP.
Decision Summary
| Decision element | Case record |
|---|---|
| GxP assessment | Material identity, status, location, authorization, and transaction history support prevention of unintended use. |
| Potential impact | Unapproved material can enter production or inventory records can misrepresent location and status. |
| Known issue | The fictional offline client permits a pick using a status cached before Quality rejection. |
| Validation conclusion | Offline picking is disabled for controlled materials until fail-closed status and reconnect reconciliation pass. |
GxP Assessment
Material identity, status, location, authorization, and transaction history support prevention of unintended use.
Affected GxP Functions
- Material and location scan
- Quarantine and release status
- Offline transaction control
- ERP synchronization
- Inventory audit history
Failure Scenarios
- Rejected material can be picked
- Stale offline status permits movement
- Duplicate synchronization changes quantity
- Wrong location is recorded
- Unreconciled transaction remains hidden
Potential Impact
Unapproved material can enter production or inventory records can misrepresent location and status.
Existing Controls
- Physical segregation
- Barcode identity
- ERP status authority
- Role restrictions
- Cycle count and reconciliation
Existing Evidence
- Scanner qualification
- ERP validation
- Supplier mobile-client tests
- Approved status mapping
Evidence Gaps
- Offline cache duration
- Reconnect order
- Duplicate prevention
- Lost-device access
Testing Approach
- Script released, quarantined, rejected, and expired statuses
- Challenge offline stale status and lost connection
- Test duplicate, delayed, and failed synchronization
- Verify reconciliation, audit history, access removal, and physical control interaction
Deviations or Known Issues
The fictional offline client permits a pick using a status cached before Quality rejection.
Validation Conclusion
Offline picking is disabled for controlled materials until fail-closed status and reconnect reconciliation pass.
Reassessment Criteria
- Mobile-client update
- Offline rule change
- ERP status or interface change
- Warehouse process change
- Material-status deviation
Limitations and unresolved questions
Offline use for controlled material remains disabled until stale status cannot authorize an inappropriate action. Other devices and synchronization conditions require coverage.
Relevant regulations and guidance
These sources apply within their stated scope. The suggested worksheet fields, test designs and fictional decisions are practitioner recommendations, unless a source requirement is expressly identified. Completing a template does not establish compliance.
Computer Software Assurance for Production and Quality Management System Software ↗
Regulatory guidance / GMP guideline · United States · February 2026
Scope: Medical-device manufacturers assuring software used in production or their quality management system.
Relevance: For medical-device production or QMS software, supports selecting assurance activities from intended use, risk and available evidence. It is nonbinding guidance and does not determine other sectors’ obligations.
Status: Final / published · Checked 2026-09-21
Publication identity, scope and status checked against the linked official source. This is not an independent audit of every retained guide statement.
Read source details and applicability →EudraLex Volume 4, Annex 11 — Computerised Systems ↗
Regulatory guidance / GMP guideline · European Union · January 2011 revision
Scope: Computerised systems supporting activities in the applicable EU pharmaceutical GMP context.
Relevance: For computerised systems used in EU GMP activities, informs lifecycle, supplier and record controls. Confirm applicability to the actual activity; the example does not establish it.
Status: Final / published · Checked 2026-09-21
The Commission index confirms the January 2011 operative revision. The linked PDF could not be retrieved in this check; retained detailed section mappings need review against an authorized copy.
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Resource: Warehouse Management Status Control
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