21 CFR Part 11 · CLIA-Designed · ISO 13485-Aligned · cGMP-Aligned · Built by Pro-Lab®

Temperature monitoring
designed for regulated facilities.

Audit-grade temperature monitoring for regulated labs and pharmacies — without enterprise pricing, quote delays, or firmware setup. Preconfigured Pro-Lab sensors go from box to first data point in under five minutes. Audit log with user attribution. Calibration tracking. Designed to support 21 CFR Part 11, CLIA, ISO 13485, and cGMP. From $69.99/device/month.

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Pro-Temp dashboard showing fridge, freezer, and ultra-low device tiles with status pills and a real-time temperature trend chart
science

Built by a diagnostics manufacturer

Pro-Lab Diagnostics USA is a 25-year ISO 13485 IVD manufacturer — not a generic IoT vendor. We understand inspections, reagents, specimens, excursions, calibration, and audit trails.

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Pricing — published

$69.99/device/mo for fridge and freezer. $79.99 for ultra-low. Plus a base plan tier. Stripe-billed. Cancel anytime. No quote calls.

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Compliance, designed-in

Audit log with user attribution. Immutable measurements. Calibration tracking. RCA workflow. Designed to support 21 CFR Part 11, CLIA, ISO 13485, cGMP.

Pro-Temp is a multi-tenant temperature monitoring SaaS for regulated facilities — pharmacies, clinical laboratories, biotech research labs, food cold-chain operations, pharmaceutical cold chain, and data centers. It ingests data from Pro-Lab–supplied sensors that ship pre-configured for your account — under five minutes from box to first data point, no firmware flashing or integration work. Pricing is published per device type: $69.99/month for fridge (2-8°C) and freezer (-20°C) units, $79.99/month for ultra-low (-80°C) units, plus a base plan tier. Built by Pro-Lab — a 25-year ISO 13485 IVD manufacturer.

Why Pro-Temp

Audit-grade monitoring, without the enterprise sales cycle.

Nine reasons regulated labs, pharmacies, biotech, and cold-chain facilities pick Pro-Temp over generic IoT vendors and enterprise compliance platforms.

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01

Built by a real diagnostics manufacturer

Pro-Lab Diagnostics USA is an ISO 13485 IVD manufacturer that understands inspections, reagents, specimens, excursions, calibration, and audit trails — not a generic IoT vendor that learned about labs from a sales deck.

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02

Transparent published pricing

No quote games. Know your monthly cost before you talk to sales. $69.99/device/mo for fridge and freezer, $79.99 for ultra-low, plus a base plan tier — billed by Stripe, cancel anytime.

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03

Preconfigured sensors — no firmware flashing

Pro-Lab sensors ship configured for your account. Plug it in, pair it, set thresholds, and start collecting audit-ready temperature data the same day — under five minutes from box to first data point. No command line, no integration work.

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04

Honest, defensible compliance language

Designed to support 21 CFR Part 11, CLIA Computer Systems, ISO 13485 record-keeping, and cGMP record-keeping. We don't claim "FDA approved software" or "fully compliant" — regulators don't certify software products, and overclaiming creates audit risk.

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05

Immutable audit-trail architecture

User attribution, reason-for-change, INSERT-only measurements, Supabase row-level security, electronic-signature framing on critical actions, quality-control flags, range validation. Temperature readings are treated as regulated records — not just chart points.

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06

RCA workflow built into the product

Pro-Temp doesn't just tell you the temperature went out of range — it helps document what your team did about it. Structured root-cause-analysis workflow for excursions, so corrective actions aren't lost in email threads. That's what inspectors actually care about.

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07

Calibration tracking with certificate storage

Per-device calibration status — current, due, overdue — with certificate number, certificate URL, and automated overdue alerts. Know which probes are current, which are due, and where the certificate is before the inspector asks.

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08

Multi-site, multi-role from day one

Six roles (Owner, Admin, Manager, Operator, Viewer, Installer), multi-site / multi-organization with Supabase row-level security, per-location dashboards and reports. Built for one clinic today and a multi-site lab network tomorrow.

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09

Self-serve trial — start today

7-day demo trial via Stripe Checkout, immediate signup, Stripe billing, cancel anytime via the customer portal. Uncommon in regulated monitoring, where most vendors gate pricing and trials behind a "book a demo" form. No procurement marathon required.

Features

Audit-grade monitoring without the enterprise quote

Twelve capabilities, all included in the tier.

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Preconfigured Sensors

Pro-Lab sensors ship configured for your account — under five minutes from box to first data point. No firmware flashing.

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Real-Time Monitoring

Continuous ingest, real-time dashboards, sub-minute alerting.

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Threshold Alerts

Severity (Info/Warning/Critical) + dwell-time eliminates false alarms.

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Audit Trail

INSERT-only measurements; full audit log with user attribution + reason-for-change.

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Calibration Tracking

Status (current/due/overdue), certificate URL, automated alerts.

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Reports + CSV Export

Summary + detailed reports up to 90 days; export for inspectors.

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Charts & Analytics

Recharts-powered dashboards with multi-time-range views.

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Root Cause Analysis

Structured RCA workflow for excursions; not lost in email threads.

groups

Multi-User + 6 Roles

Owner / Admin / Manager / Operator / Viewer / Installer.

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Multi-Site / Multi-Org

Supabase RLS; per-location dashboards and reports.

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Bluetooth Pairing

In-app sensor pairing for compatible devices.

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Built by Diagnostics

Pro-Lab Diagnostics USA is a 25-year ISO 13485 IVD manufacturer — not a generic IoT vendor.

How it works

Connect a sensor the same day.

1

Sign up and start

Two ways to begin — sign up and pay to start immediately, or run a 7-day demo trial first. Pick on the pricing page.

2

Add a location and a device

Setup wizard creates your org, location, and first device. Time: 10–15 min.

3

Connect in minutes

Pair your Pro-Lab sensor through the app's guided setup — under five minutes from box to first data point. No firmware flashing, no command-line, no integration work.

4

Configure alerts

Set thresholds, severity, dwell time, recipients. Email alerts today; SMS and phone-call escalation on the roadmap.

How Pro-Temp compares

Transparent pricing in a quote-only category.

Every cell verified 2026-05-09 from public sources.

Pro-Temp DicksonOne ELPRO Paper logs
Pricing transparencyPublishedQuote-onlyQuote-onlyn/a
Built by IVD diagnostics manufacturercheck_circlecancelcanceln/a
Sensor setup time< 5 minVendor-installedVendor-installedn/a
Self-serve trial (Stripe)check_circlecancelcanceln/a
21 CFR Part 11 audit logDesigned-tocheck_circlecheck_circlecancel
Calibration trackingcheck_circlecheck_circlecheck_circlecancel
SMS / phone-call escalationRoadmapcheck_circlecheck_circlecancel
Mobile native appsRoadmapcheck_circlecheck_circlecancel
GxP validation services (IQ/OQ/PQ)Partner-roadmapcheck_circlecheck_circlecancel
Vendor tenureNew100+ years40 yearsn/a
Per-device $/mo (fridge)$69.99~$200–400/yr quotePremium quote$0

All competitor data verified 2026-05-09 from public sources. We don't claim what we can't source. See full breakdowns: vs DicksonOne, vs ELPRO, vs Paper logs.

Pricing

Pick your plan, mix your devices.

Plan subscription + a small per-device monthly subscription, plus a one-time hardware charge per device. Drag the sliders to see your monthly bill and what's due today.

Starter

$79 /mo

For pharmacies and small clinics.

  • checkUp to 5 devices
  • checkCore monitoring + alerts
  • checkAudit log + calibration tracking
  • checkEmail support
Devices: 1 / 5
Room temp (24°C / 75°F)$14/mo each
0
Refrigerator (2–8°C / 36–46°F)$14/mo each
1
Freezer (-20°C / -4°F)$14/mo each
0
Ultra-low (-80°C / -112°F)$24/mo each
0
Plan subscription$79/mo
Device subscriptions$14/mo
Monthly total$93/mo
Device hardware$69.99
Due today$69.99
Get Started Start 7-Day Demo Trial
Most popular

Professional

$149 /mo

For multi-fridge labs and clinics.

  • checkUp to 15 devices
  • checkEverything in Starter
  • checkAdvanced QC + RCA workflow
  • checkPriority support
Devices: 6 / 15
Room temp (24°C / 75°F)$14/mo each
0
Refrigerator (2–8°C / 36–46°F)$14/mo each
6
Freezer (-20°C / -4°F)$14/mo each
0
Ultra-low (-80°C / -112°F)$24/mo each
0
Plan subscription$149/mo
Device subscriptions$84/mo
Monthly total$233/mo
Device hardware$419.94
Due today$419.94
Get Started

Enterprise

$299+ /mo

For multi-site portfolios. Unlimited devices, custom pricing above 100.

  • checkUnlimited devices
  • checkEverything in Professional
  • checkAudit-trail exports + multi-site dashboards
  • checkSSO + on-prem option (roadmap)
  • checkDedicated account manager
Devices: 20 / 100 · need more? talk to sales
Room temp (24°C / 75°F)$14/mo each
0
Refrigerator (2–8°C / 36–46°F)$14/mo each
20
Freezer (-20°C / -4°F)$14/mo each
0
Ultra-low (-80°C / -112°F)$24/mo each
0
Plan subscription (from)$299/mo
Device subscriptions$280/mo
Monthly total$579/mo
Device hardware$1,399.80
Due today$1,399.80
Get Started Talk to Sales

Pricing in USD. Plan billed monthly or annually via Stripe; per-device monthly subscription billed alongside. Device hardware is a one-time charge collected at checkout. 7-day demo trial available as an alternative to paid sign-up. Cancel anytime via the Stripe customer portal.

Pro-Temp compliance shield with 21 CFR Part 11, CLIA, ISO 13485, cGMP badges

Compliance & security

Designed for the audit you'll have.

Pro-Temp is purpose-built to support 21 CFR Part 11, CLIA Computer Systems requirements, ISO 13485 record-keeping, and cGMP record-keeping. We say "designed to support" because regulators do not certify software products themselves — they certify the laboratories, pharmacies, and manufacturers that use the software.

draw21 CFR Part 11 — controls implemented

Audit trail with user attribution and reason-for-change, immutable measurements (INSERT-only), record protection via Supabase RLS, electronic-signature framing on critical actions. Designed to support §11.10 controls.

biotechCLIA Computer Systems

Per-measurement traceability, equipment calibration tracking with NIST-traceable certificate storage, alert documentation with user attribution, quality-control flags (valid/suspect/invalid), and range validation.

distanceData residency & encryption

AWS US-region via Supabase. Row Level Security per org. Encrypted at rest (AES-256) and in transit (TLS 1.2+).

verified_userBuilt by an ISO 13485 manufacturer

Pro-Lab Diagnostics USA is an ISO 13485 manufacturer. The Pro-Temp software is not separately ISO 13485 certified; the parent organization is. Pro-Lab also makes Microbank® (Manchester Met–validated cryostorage).

blockWhat we do not claim

"FULLY 21 CFR Part 11 compliant" / "ISO 13485 certified software" / "HIPAA compliant" / "FDA approved" / "GxP validated" — none. We use "designed to support" framing because regulators don't certify software products.

credit_cardTrial — what your card is for

A 7-day demo trial is available via Stripe Checkout as an alternative to paid sign-up. Cancel any time via the Stripe customer portal.

FAQ

Questions buyers actually ask

Is Pro-Temp 21 CFR Part 11 compliant?add

Pro-Temp is designed to support 21 CFR Part 11. Audit-trail capture with user attribution, immutable measurements (INSERT-only), reason-for-change, and electronic-signature framing are implemented. Regulators do not certify software products themselves; they certify laboratories, pharmacies, and manufacturers that use them.

How long does it take to install a Pro-Temp sensor?add

Under five minutes from box to first data point. Pro-Lab sensors ship preconfigured for your account — pair through the app, set thresholds, and start collecting audit-ready temperature data the same hour. No firmware flashing, no command line, no integration work.

How much does Pro-Temp cost for a 5-fridge pharmacy?add

Per-device line items: 5 × $69.99 = $349.95/month, plus a base plan tier (Pro tier covers 3–7 devices). See in-product Pricing page for current base-plan rates.

Does Pro-Temp have a free trial?add

Yes — a 7-day demo trial is available via Stripe Checkout as an alternative to paid sign-up. Cancel any time via the Stripe customer portal.

What about SMS or phone-call alerts?add

Today, email only. SMS and phone-call escalation are on the Premium / Enterprise roadmap (Twilio integration). For deployments that require SMS today, evaluate DicksonOne or Sonicu; if email-to-on-call is sufficient, Pro-Temp's per-device pricing is materially lower.

Does Pro-Temp integrate with my LIS or LIMS?add

No. Pro-Temp is environmental monitoring, not a clinical-result platform. We don't push HL7 or FHIR. CSV export gets data into any downstream system. Public REST API for customer use is on the Premium roadmap.

What about IQ/OQ/PQ validation for pharma manufacturing?add

We don't sell IQ/OQ/PQ validation services directly today — those are on the Premium-tier roadmap (partner-delivered). For pharma manufacturers needing vendor-delivered IQ/OQ/PQ available now, ELPRO or Sonicu are stronger near-term fits. Ask on the Talk to Sales call if you need a referral to a regulatory-validation consultant.

How do I handle calibration?add

Pro-Temp tracks per-device calibration with status (current/due/overdue/unknown), certificate number + URL, and automated alerts on overdue. We don't perform calibration ourselves — bring your existing NIST-traceable / ISO/IEC 17025 calibration vendor.

Real-time monitoring, designed for the audit you'll have.

Sign up and pay to start immediately, or run a 7-day demo trial — plug in a sensor, configure thresholds, and ingest data the same hour. Or book a 30-minute demo and bring your last inspection finding.

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