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When Monitoring Matters Most,We Are Already On It.

Continuous monitoring depends on more than the system that runs day-to-day. It depends on who is watching when an alarm fires, how quickly a calibration can be restored, and who stands beside you when an auditor arrives.

Talk to a Specialist Explore Monitoring-as-a-Service
24/7 / 365 coverage NIST-traceable & ISO 17025 calibration FDA · USDA · GxP audit-ready
01 / Support
24/7 Monitoring Response

Live alarm triage and technical support
around the clock.

Monitoring is only as defensible as the response behind it. Our coverage runs continuously — across asset and equipment alerts, and direct technical support for the people running the system.

QC Response Operations
Live · Synced 12s ago
Critical Excursion 02:14:33 EST
Cold Store 4 — Vault B / Sensor LRS-204
Reading −14.2°C Setpoint −20°C ± 2 Δ +3.8°C
Response Timeline
+0:00 Alert received · Vault B excursion detected Detected
+0:10 QC triage · alarm verified & confirmed Triaged
+0:32 On-call escalation to QA Director, J. Mendez In progress
+0:55 Corrective action verified · log entered Pending
Operations live · 24/7/365 Avg first-touch < 1 min
24/7
Continuous coverage
< 1 min
First-touch response
Multi-tier
Escalation depth

24/7 Asset & Equipment Monitoring Alerts

Every critical sensor, gateway, and connected asset is watched continuously. When a parameter drifts, gateway disconnects, or an event signal triggers, our operations team receives the alert in real time and begins triage before your facility has to act.

24/7 Technical Support

Direct line to QC technicians who know your deployment. Configuration questions at midnight, sensor replacement during a weekend audit, urgent calibration verification — handled by people who built the system, not a generalist help desk.

Documented Response, Every Time

Each alert generates a tamper-evident response record — timestamp, action, acknowledgment, resolution. Your audit narrative is built automatically, not reconstructed after the fact.

Talk to a Response Specialist
01
Detection

Sensor or asset signals an out-of-spec event; alert hits the operations console.

02
Triage

MySIrius verifies the event, distinguishes true alerts from just an 'open door', and classifies severity.

03
Escalation

Your on-call contacts are notified along the path you defined — no untrained handoffs. Work orders are automatically created, service vendors notified.

04
Resolution

Corrective action is verified and the response narrative is captured to your records.

Common questions
Response operations run continuously — 24 hours a day, 365 days a year, including holidays and weekends. There is no off-hours queue or callback window.
No — it precedes it. QC handles first-touch detection and triage, then escalates to your defined contacts only when human action is required. Your team sees fewer false alarms and clearer narratives.
Every action, acknowledgment, and resolution is captured with a timestamped, tamper-evident log entry — written directly into your MySirius record. ALCOA+ compliant.
Free assessment · ~6 minutes

Run the REM Risk Assessment

See how your current monitoring response stacks up. Receive a maturity rating and a defensibility report you can share with your QA team.

Start Assessment
02 / Support
Hot-Swap Sensor Service

Full calibration in under five minutes
with zero monitoring downtime.

Calibration windows are unavoidable. Calibration downtime is not. We ship pre-calibrated, identical sensors; your team performs a simple swap; the original returns to us for recalibration. Monitoring never goes dark.

Under five minutes, end to end

Identical hardware. Identical firmware. Identical mounting. Pre-calibrated to the same setpoint configuration as the sensor it replaces. The swap is mechanical, not technical — anyone trained on the system can perform it.

Zero downtime on the monitoring record

The replacement sensor begins logging the moment it's mounted. There is no calibration gap to defend in an audit, no stretched timestamp, no "best estimate" period — just continuous, traceable readings.

NIST-traceable, ISO 17025 documentation

Every replacement unit ships with its own current calibration certificate. The returning sensor is recalibrated in our ISO 17025-accredited lab and reissued with fresh paperwork — full chain-of-custody preserved.

Plan a Hot-Swap Cycle
Hot-Swap · Live cycle
In service
Cal expiring
Nano SPY sensor in service
Cal expiring
EXP 2026-04-30
New sensor
Pre-calibrated
Pre-calibrated replacement sensor
Cal current
EXP 2027-04-29
< 5min
Total swap time
0s
Monitoring downtime
ISO 17025
Recalibration accreditation
01
Receive

Pre-calibrated identical sensor arrives with current cert and active calibration.

02
Swap

Five-minute mechanical swap.
No tools, no software reconfiguration.

03
Return

Original sensor ships back in the same case for recalibration.

04
Recalibrate

Reissued with fresh NIST-traceable,
ISO 17025 paperwork for the next cycle.

Common questions
Yes — the replacement is registered as a calibration revision of the original asset (e.g. LRS-204·R) so the location's monitoring record is continuous, with full chain-of-custody back to each calibration event.
Both units are NIST-traceable and within accredited tolerance. Reading deltas at hot-swap are expected within a known tolerance. Differences are recorded, attached to the asset history, and visible in the audit log. There is no "expected variance" left undocumented.
Quarterly, semi-annual, or annual cycles are all supported. We align swap windows to your validation schedule so calibration never falls outside spec — even if your standard interval is six months and a single sensor needs an out-of-cycle recalibration.
03 / Support
Audit Support

Stand beside you when the auditor arrives.

Audits are a test of your monitoring architecture under pressure. Whether the body is the FDA, USDA, your local regulatory authority, or a customer's quality team, we provide the documentation, the technical narrative, and — if you need it — a person beside you in the room.

Validation Records
DOC-VAL-0421
IQ / OQ / PQ Validation Pack
Cold Store 4 · Vault B · Effective 2026-02-14
Sensors validated24 / 24
Mapping studyApproved · J. Mendez
Setpoint matrixWithin spec
Approval signatureElectronic · Part 11
✓ Approved
ALCOA+ Logs
DOC-LOG-1188
Continuous Monitoring Log
Vault B · 2026-04-01 → 2026-04-30 · 30 days
Readings captured2,160,000
Excursions2 · resolved
Tamper events0
Integrity hashSHA-256 · verified
✓ ALCOA+
Calibration Cert
CAL-LRS-204·R
NIST-Traceable & ISO 17025 Calibration Certificate
Sensor LRS-204·R · Issued 2026-04-29
Reference standardNIST-traceable
Tolerance±0.2°C verified
Next due2027-04-29
AccreditationA2LA · ISO 17025
✓ NIST-traceable
✓FDA ✓USDA ✓21 CFR Part 11 ✓GMP / GxP ✓HACCP ✓FSMA 204

Audit-pack assembly

Validation protocols, ALCOA+ monitoring logs, calibration certificates, and tamper-evident integrity reports — pre-structured for FDA, USDA, GxP, HACCP, and FSMA 204 review formats. Generated on demand, not assembled the week before.

On-site audit liaison

For high-stakes inspections, a QC compliance specialist is in the room — answering technical questions about the monitoring architecture, walking auditors through records, and reducing the cognitive load on your QA director on the day that matters most.

Pre-audit narrative review

Before the audit window opens, we walk your team through the monitoring story — what the records show, where the strong points are, and where to expect questions. No surprises during the inspection itself.

Talk to an Audit Specialist
Audit Response Pack

One-click export of validation, monitoring, calibration, and event records — formatted for the requesting body.

Question Walkthrough

Mock audit questions tied to your monitoring data. Practice the responses your auditor is likely to ask.

Findings Remediation

If a 483, warning letter, or non-conformance is issued, we help author the response and remediation plan.

Common questions
FDA (drug, device, food), USDA, state and provincial health authorities, third-party GMP / GxP auditors, customer quality teams, ISO certification bodies, and FSMA 204 traceability auditors. We adapt the documentation format to match the body's expected review structure.
Yes — for scheduled audits, a QC compliance specialist can be physically present to handle technical questions about the monitoring system. For unannounced inspections, we can provide remote support within the first hour.
We focus on the monitoring portion of the audit — the data integrity, sensor validation, calibration traceability, and response narrative. For broader audit support, we partner closely with your existing QA team rather than replace them.
Featured · Monitoring-as-a-Service

One monthly fee.
Every part of your monitoring compliance.

Hardware, software, calibration, 24/7 monitoring response, and audit support — bundled into a single subscription so your facility focuses on its product, not on assembling a compliance stack.

Hardware

LoRa, Nano, Nano Link, and Digital sensor families plus gateways — provisioned and maintained.

Always-latest sensors
MySirius Software

Real-time logging, alarm management, ALCOA+ records, and on-demand audit-ready reporting.

21 CFR Part 11
Calibration

Hot-swap cycles included. NIST-traceable, ISO 17025-accredited recalibration on the schedule you need.

NIST & ISO 17025
24/7 Monitoring Response

Continuous alert triage and technical support — the operations team is on duty around the clock.

< 1 min first-touch
Audit Support

Audit-ready record packs, narrative review before each inspection, and on-site liaison for high-stakes reviews.

FDA · USDA · GxP
Lifetime Warranty & Upgrades

System-wide lifetime warranty plus rolling sensor upgrades. Hardware advances ship to your sites — you never run aging fleet.

Always-latest hardware
One monthly fee

Monitoring-as-a-Service

MaaS
Predictable subscription · scaled to your facility
  • Sensor hardware & gateway lifecycle
  • MySirius platform license
  • Hot-swap calibration cycles
  • 24/7 monitoring response
  • Audit-pack assembly & on-site support
  • Validation refresh as your facility evolves
  • Lifetime system warranty
  • New sensor upgrades
Talk to a Services Specialist
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Free calculator · Scenario-based

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