Skip to main content
Validation Services

Compliance BeginsBefore The First Reading.

A monitoring system is only defensible if its sensors are calibrated to a known standard, mapped to the spaces they protect, and validated through a documented protocol. We handle all three — so the data your auditor reviews is verifiable from the first decimal place.

Talk to a Specialist Explore Monitoring-as-a-Service
NIST-traceable · ISO 17025 accredited Onsite & in-lab calibration IQ / OQ / PQ protocol authoring
01 / Calibration
NIST-Traceable & ISO 17025 Calibration

Every reading verifiable to the national standard.

Calibration is what turns a sensor reading into evidence. Calibrations are performed onsite and through ISO 17025 accredited labs against NIST-traceable references — issued with serialized certificates, multi-point coverage, and explicit deltas at every check.

Technician documenting temperature calibration with an Additel ADT875 dry block and Fluke 1524 reference thermometer.
Onsite
In-place

Calibration performed at your facility against portable NIST-traceable references. No sensor removal, no monitoring gap.

In-Lab
ISO 17025 accredited

Multi-point calibration through ISO 17025 accredited labs — environmental chambers, dual-redundant references, and full documentation.

NIST-traceable certificates

Every sensor calibration ships with a serialized certificate that traces back to a National Institute of Standards reference. Tolerance, points tested, deltas, and accreditation are all explicit on a single page.

ISO 17025 accredited methods

Calibration procedures, reference standards, and uncertainty budgets are governed by ISO 17025 accreditation. The methods aren't just defensible — they're externally audited on the cycle the standard demands.

Multi-point coverage

Calibrations span the full operating range — typically 4-point for temperature, with deltas recorded at each point. The curve is explicit and the tolerance is visible everywhere on it.

On the schedule your protocol demands

Quarterly, semi-annual, or annual cycles. We track your calibration intervals against your validation protocol so nothing drifts out of period — and we surface the schedule inside MySirius alongside the live readings.

01
Schedule

We align cycles to your validation protocol and audit calendar — no surprise expirations.

02
Calibrate

Multi-point calibration onsite or through ISO 17025 accredited labs against NIST-traceable references.

03
Document

Certificate issued with deltas, tolerance, uncertainty, and full chain-of-custody — attached to the asset record.

04
Track

Calibration status surfaces in MySirius alongside the live reading; the next-due date drives the next cycle.

Common questions
NIST-traceable means the reference used during calibration has an unbroken chain back to a NIST primary standard. ISO 17025 is the accreditation of the calibration laboratory — proving the methods, environment, and uncertainty budget are externally audited. Calibrations issued through this program are both.
Yes — onsite calibration uses portable NIST-traceable references and is done in-place. For full multi-point lab calibration without monitoring downtime, our Hot-Swap Sensor Service is the typical path: a pre-calibrated identical sensor takes over while the original returns to the lab.
Temperature, relative humidity, differential pressure, CO₂, O₂, and dew point are all supported and within scope. We support many other parameters as well, just speak to one of our Specialists for a full list.
Each certificate is attached to the sensor asset record in your MySirius portal. Calibration date, next-due date, deltas, and reference identifiers are visible on the same screen as the live reading — and exported automatically into the audit-pack alongside the monitoring log.
Onsite or in-lab · NIST-traceable

Need calibration? Schedule yours today.

We'll align the calibration to your procedures and confirm a date — onsite or in lab.

Schedule Calibration
02 / Mapping & Qualification
Mapping & Qualification

See where the air actually
stratifies, drifts, and recovers.

A monitoring sensor protects only the volume it can actually represent. Mapping studies expose the thermal, humidity, and pressure behavior of the real space — so sensor placement is driven by physics, not floor plans.

Planning to run the study with your own team? Explore equipment rental with an included protocol.

Distributed sensor study

A grid of calibrated thermal mappers placed at representative volumes — corners, returns, supply diffusers, product faces. Coverage is determined by the chamber's geometry and operating envelope, not a fixed checklist.

Loaded, unloaded, & recovery profiles

The space is mapped in each operational state — at rest, under load, and during recovery from door-open or power-cycle events. The chamber's worst-case behavior gets named, not estimated.

Hot & cold spot identification

Heat-mapped output identifies the locations of greatest gradient — the points that need permanent monitoring sensors and the volumes where storage should be excluded.

Qualification report & placement plan

Output is a signed mapping & qualification report — heat maps, recovery curves, statistical summaries, and a sensor-placement plan you can hand to your validation team and your auditor.

Plan a Mapping Study
Chamber Mapping · Cold Store 4 · Vault B Illustrative study · 32 mappers · 24 h
Ceiling +1.2°C
Mid −19.8°C
Floor −20.4°C
M-01 −16.2°C
M-08 −20.0°C
M-12 −20.1°C
M-19 −22.1°C
M-22 −20.0°C
Setpoint−20.0°C
Hot spot−16.2°C
Cold spot−22.1°C
Mean Δ±1.4°C
In-spec mapper Hot-spot mapper Cold-spot mapper Warm strata Target band Cool strata
32 pts
Mapped volumes
24 h
Study window
3
Operational states
01
Scope

Walk-through of the chamber, warehouse, or transit envelope; placement strategy is drafted from geometry and operating profile.

02
Deploy

Calibrated mappers are positioned across the volume — ceilings, returns, product faces, transit dunnage. Logging begins.

03
Analyze

Loaded, unloaded, and recovery profiles are extracted. Hot and cold spots are statistically isolated.

04
Qualify

Signed report with heat maps, recovery curves, and a permanent-sensor placement plan ready for protocol approval.

Choose how to run your mapping study.

Self-mapping equipment rental

Run your own mapping study.
Equipment and protocol included.

Rent Qualified Controls mapping equipment and conduct your study with a QC-provided protocol that guides your team through mapping activities following applicable ISPE guidance.

Available to existing QC customers and organizations new to Qualified Controls.

Request a Mapping Rental Quote
QC-performed mapping

Have QC perform the study.

Bring in Qualified Controls to scope the study, deploy mapping equipment, analyze the results, and prepare the agreed qualification deliverables.

Discuss your equipment, operating conditions, and documentation needs with our team.

Plan a QC-Performed Study
Common questions

No. Mapping equipment rentals are available to existing customers and organizations new to Qualified Controls. The rental includes a QC-provided protocol to guide your team's mapping activities following applicable ISPE guidance. Explore the self-mapping rental option.

There is no single sensor count that fits every room. Start with usable storage volume, rack heights, airflow, doors, loading patterns, and known problem areas. The approved protocol sets the number and positions of temporary mapping sensors. Results then inform permanent monitoring locations; the two counts need not match.

Agree the deliverables before the study: an approved protocol and acceptance criteria; a sensor-location drawing; sensor IDs and calibration certificates; time-stamped readings and operating-event records; analysis of hot spots, cold spots, and recovery; deviations and conclusions; and a permanent-monitoring placement recommendation. Confirm which documents Qualified Controls will author and which your quality team will approve.

Share room dimensions and rack heights, a floor plan, required temperature range, typical and maximum loads, door and HVAC locations, operating hours, and available shutdown windows. Include previous studies, your qualification requirements, and the report deadline. These inputs let us scope the sensor count, operating challenges, field time, and documentation before you commit.

Walk-in coolers and freezers, blast freezers, refrigerated and ambient warehouses, GMP cleanrooms, stability chambers, autoclaves, lyophilizers, transit trailers and reefers, and ULT freezers. Each has its own placement strategy and study duration.

The approved protocol determines the logging period from operating cycles, loading, door activity, defrost cycles, and seasonal risk. Logging time is only part of the schedule: allow for protocol approval, installation, any planned challenges, analysis, and report review. Mapping may be performed during normal operations where the protocol allows; empty-load or recovery tests may need a planned access or shutdown window.

Changes to racking, usable storage volume, loads, doors, HVAC, setpoints, or equipment can change temperature distribution. Review them through change control and decide whether a targeted or full study is needed. Unexplained excursions, adverse trends, and the periodic review in your qualification program can also trigger reassessment. Document the rationale and update permanent sensor placement when the evidence supports it.

Reports follow the GAMP 5, USP <1079>, WHO TRS, and IEST RP-CC012 frameworks as relevant. We adapt the deliverable structure to the regulatory body conducting the review — same data, format that matches the auditor's expectations.
Planning example
A walk-in cold room with tall racks and a busy door

For this illustrative room, the study would compare storage positions at different heights and assess areas influenced by the door and cooling airflow. Record normal loading and door activity alongside the readings. A warm location that appears only during loading may need a different response from a consistently warm storage zone.

From study to monitoring
Use the evidence to choose the next step

Review the results against the approved criteria, address unsuitable storage areas, and select representative permanent monitoring positions. The example does not prescribe a universal sensor count or study length. Plan your facility’s mapping study →

Featured · Monitoring-as-a-Service

Mapping refresh included as your facility evolves

Layout change, HVAC retrofit, new product line — under MaaS, re-qualification of the affected spaces is included on the same monthly subscription as hardware, software, and audit support.

Learn about MaaS
03 / IQ / OQ / PQ Validation
IQ / OQ / PQ Validation

One protocol. Three phases. Defensible end-to-end.

IQ confirms the system was installed as specified. OQ confirms it operates as specified.  PQ confirms it performs in the real environment, under real load. Our validation team authors and executes the protocol — leaving you with a complete, audit-ready binder before the system goes live.

Phase 01 IQ

Installation Qualification

Confirms the MySirius environment is reachable and the network is configured to specification before any operational testing begins.

Test programsIQ
  • MySirius Accessibility VerificationClient domain reachable from a workstation web browser.
  • Network port verificationTCP 13252 (HTTP) or 8443 (HTTPS) open for LoRa gateways.
  • Training prerequisites confirmedPersonnel training records on file before execution.
  • Signed IQ reportDiscrepancies logged on QF08 and closed before OQ begins.
Phase 02 OQ

Operational Qualification

Exercises the system's regulated functions — access controls, recovery, alerts, and audit trail — against documented acceptance criteria.

Test programsOQ
  • 21 CFR Part 11 & User Access ControlsAccounts, password policy, session limits, electronic signatures.
  • Recovery from Service InterruptionPower loss, network failure, cellular failover, PDF / CSV reporting.
  • Alert FunctionEmail, SMS, voice-call notifications and acknowledgement reasons.
  • Audit Trail FunctionConnection, configuration, and data-change events captured.
Phase 03 PQ

Performance Qualification

Confirms the deployed system performs against the URS and is ready for client release into GxP production.

Test programsPQ
  • Retrieval VerificationRecorded data retrievable and reportable from the live system.
  • Client ReadinessSOPs, training records, and user roles in place for go-live.
  • Validation Summary ReportURS / Traceability Matrix closed; discrepancies resolved.
  • Signed PQ releasePost-execution approval by System Owner & Quality Assurance.
Protocol Pack
Single binder, three phases — authored, executed, and signed
IQ / OQ / PQ Validation Pack PROT-IOPQ-0421
URS & system specApproved
IQ test cases42 / 42
OQ test cases68 / 68
PQ run duration14 days
Excursions0 unresolved
ApprovalElectronic · 21 CFR Part 11
Standards Aligned
The frameworks the protocol speaks to.
GAMP 5Computerized systems
21 CFR Part 11Electronic records
EU Annex 11Computerised systems
USP <1079>Storage & transport
WHO TRSCold-chain qualification
FSMA 204 / HACCPFood traceability
Common questions
Both. Most engagements include protocol authoring against your URS and system spec. We can also execute against an existing internal protocol — your validation team retains ownership of the authoring path, and we provide the field execution and signed reports.
Yes — for change control events (software upgrades, sensor tier upgrade, layout changes, new product lines), we run a scoped re-qualification covering only the impacted requirements. Output is a delta report appended to the original validation binder.
From kick-off to PQ release, a single chamber or warehouse typically runs 1-2 weeks — driven primarily by the PQ duration (load profile + statistical study window). Multi-site programs run in parallel waves on a shared protocol structure.
Yes — protocols, signatures, deviations, and the signed reports are all captured under Part 11 controls (electronic signatures, audit trails, time-stamped records). The validation pack is generated in the same data-integrity envelope as the monitoring records it qualifies.
Free check · ~8 minutes

Run a Validation Readiness Check

Tell us where you are in the lifecycle — new system, mid-deployment, post-change. We'll return a phase-by-phase readiness map with gaps called out before you commit to a protocol.

Start Check
Featured · Monitoring-as-a-Service

One monthly fee.
Every part of your monitoring compliance.

Hardware, software, calibration, mapping refresh, validation upkeep, 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
  • Mapping & qualification refresh
  • 24/7 monitoring response
  • Audit-pack assembly & on-site support
  • Validation upkeep as your facility evolves
  • Lifetime system warranty & upgrades
Talk to a Services Specialist
View Pricing & Service Plans →
Free calculator · Scenario-based

Run the ROI Calculator

Compare per-service costs against an MaaS subscription for your facility size, sensor count, validation frequency, and audit cadence. Receive a side-by-side projection in minutes.

Calculate ROI