Years ago, the temperature release process in Pharma was sacred ground.

It belonged entirely to the Quality team—manual, meticulous, and mostly offline.

• Temperature data came in via PDF.
• Download & open the PDF or CSV docs.
• Conduct TOR calculations & analysis if temperature excursion / deviation had occurred.
• Close out docs if no temperature issues.
• Manual entry into QMS.
• Paper trails of approval.
• One logger at a time.

And always—always—“do not touch” unless you were a QA professional with 10+ years of badge wear and GxP paranoia in your DNA.

But in the last 2–3 years, something changed.

Pharma started to realize that the downstream consequences were adding up:

• Days (sometimes weeks) of delay in product release
• 50-email threads with attachments including data loggers, real-time IoT reports, RCA & CAPA forms
• Different processes for real-time vs. passive loggers, with different software in play if multiple devices are being used
• Quality headcount ballooning just to process PDFs
• Complex workflows that require batch level traceability, or split shipments take longer
• And massive costs tied up in manual, duplicative workflows
  
  

So the best in the business made a call: Keep quality oversight intact. But digitize & automate everything else.

Why Streamlining Product Release is the Smartest Decision You’ll Make This Year

If you’re evaluating partners to help digitize and automate your product release workflows, here’s what actually matters:

Digitized Product Profile Repository

No more hunting down static PDFs or sifting through OneVault to find the stability budget. Your system should know every product’s:

• Shipping Temperature Range (STR)
• Stability thresholds across multiple time-temperature combinations
• Immediate vs. cumulative excursion tolerances
• Expiry rules and exception flags
• Sensitivity to stability budget relative intervention SOPs

This is the foundational block of any automated temperature release process. If it’s not digitized, forget automation.

Device Agnostic, Passive & Real-Time

The days of being locked into a single logger are over -- most companies dual or parallel source their data loggers and real-time IoT devices, and want one place to handle:

• API-enabled data ingestion
• Passive PDF mass uploads
• CSV/ZIP/manual entry fallback
• Blended datasets (passive + active + carrier milestones)
• Document repository for broader shipment documents

If your release system can’t harmonize that into one coherent stream, it’s a nonstarter.

Automatic TOR (Time Out of Range) Calculation

You shouldn’t be squinting at graphs to decide if 3 hours at 9°C is within budget. Your platform should:

• Know the rules for each product
• Contextualize the excursion
• Flag deviations
• Trigger disposition workflows
• Auto-generate a validated release report

Instantly. No spreadsheets. No “let me double-check.”

Workflow Configuration, Not Custom Code

Every pharma company has nuance.

Your release process isn’t just approve/reject.

You’ve got split shipments. Batch release. Site-specific overrides. Edge cases. TOR add-backs. QA manager sign-offs. Escalations.

The best platforms don’t ask for scope change requests—they give you a workflow builder that lets you configure:

• Approval logic based on products, events or types of temperature issues
• Configuration towards ‘human-in-the-loop’ approvals and escalations
• Communication portal with pre-programmed templates and one-click send options
• Integration with QMS

And they let you update that logic without calling a developer.

GxP-Validated with Full Audit Trail

Compliance isn’t negotiable. But the idea that compliance requires everything to be manual? That’s dated sentiment.

The new standard: a GxP-validated platform with full traceability for every step of the release decision.

• Who uploaded the file
• Which rules triggered which outcome
• Who reviewed the deviation
• What action was taken
• When the release was approved or rejected, by whom – and why

It should be tighter, more consistent, and more defensible than any manual process you’ve ever run.

What’s Underneath All This? One Big Shift:

Digitize and Automate.

That’s the whole game.

From passive data to product profiles, from TOR thresholds to workflows—if it’s still locked in a PDF, a spreadsheet, or someone’s head, you’re not ready to scale.

And scale is coming fast—faster than you think.

So Who’s Already Doing It?

The best teams already are. They’re not talking about it on webinars. They’re not pitching it on slide decks.

They’re quietly replacing manual decisions with automated ones.

They’re building trust in the system so that QA oversight remains—but QA effort shrinks.

They’re getting product to market faster, with fewer headcount, and higher confidence.

And they’re unlocking untapped capacity in their QA teams to focus on the hard stuff.

Where PAXAFE Comes In

PAXAFE’s temperature release module provides:

• Digitized, version-controlled product profiles
• Passive & active data ingestion, with direct device integrations
• Automated TOR analysis with multi-scenario support
• Workflow builder for configurable workflows / processes
• Complex workflow support (e.g. TOR add-backs, batch traceability & release, etc.)
• GxP-validated with full audit trail
• Integration with your QMS, ERP, and SAP BRH
• Embedded AI assistant (ATHENA) for smart recommendations

It’s what happens when orchestration platforms grow up—and start making decisions.

Ready to move beyond PDFs and spreadsheets? Request a demo and automate your temperature release with confidence.