Make every release decision defensible.
Connect end-to-end temperature exposure, stability budgets, receiving checks, and batch lineage in one defensible release decision, with the evidence and approvals your Quality team needs.
The question you own
Can we release this batch with confidence?
Condition, stability, receiving checks, and documents must support one decision. Quality has to connect the evidence.
Where the handoff breaks
A temperature report is only part of the release record.
Condition data explains exposure. Stability data explains tolerance. Receiving and quality records explain the remaining checks. Release slows down when Quality has to assemble the complete picture by hand.
Exposure
Devices and shipment reports
What the product experiencedTolerance
Product and stability files
What the product can tolerateDisposition
QMS, checks, and signatures
Why release is justifiedThe delay becomes held inventory and more manual investigation.
The work you own
You own the release. The record has to be rebuilt.
Temperature is one part of disposition. Quality must also verify product limits, damage and security checks, documents, and batch history before accepting the evidence for release.
| Your responsibility | Where work fragments | What the disconnected setup cannot give you |
|---|---|---|
Assess condition against product tolerance | Device reports, stability budgets, and manufacturing or warehouse exposure live in separate records. Teams reconcile time in and out of range manually. | Assess end-to-end TIR/TOR against the correct product profile, including false excursions and eligible add-back. |
Complete the disposition checklist | Damage inspections, document verification, and SOP-specific checks move through spreadsheets, email, and quality systems. | Resolve every required check in one governed workflow with a clear release status. |
Defend the decision and trace the batch | Signatures, source reports, and shipment-to-batch relationships are scattered. An audit means reconstructing who reviewed what and why. | Follow product lineage and retain attributable evidence and signatures with the decision. |
What changes with PAXAFE
Temperature release workflow automation for Quality.
Product Disposition & Lineage connects manufacturing to fit-for-use, so the release workflow carries its own evidence.
Ingest data from different devices and assess end-to-end time in and out of range across manufacturing, warehousing, and transit. Apply stability budgets and resolve false excursions with TOR add-back.
Explore Product Disposition & LineageCombine condition, damage and security, document, and custom SOP checks. Support multi-product and split-shipment release with digitized review and Part 11 signatures.
Explore WorkflowsTrace batches through the shipment record and retain the audit trail. Connect to QMS and SAP, while risk-proportionate software assurance supports the validated state.
Explore Quality managementOne connected record. Every decision traceable.
The value for your team
Less friction.
More confidence in the decision.
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Faster qualifying release decisions
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Less manual reconciliation
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Complete batch traceability
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Audit evidence in the record
Questions answered
How can Quality review a shipment without rebuilding its history?
Connect the product profile, batch lineage, temperature exposure, receiving checks, and supporting documents before the release review begins. Product Disposition & Lineage brings these inputs into one checklist and records the decision and signatures, allowing Quality to review the connected evidence rather than reconcile each source separately. Explore product disposition and batch lineage.
See it in your operation
See your release process in one record.
Bring a product profile and your disposition checklist. We’ll show how condition assessment, evidence, and signatures work together.