Regulatory compliance
When a state pharmacy board, manufacturer QA team, or food safety inspector asks for documentation, the answer is already in the device. No export fees. No IT ticket. No third-party portal in the chain of custody.
All Exposensia devices carry FCC authorization for operation in the United States. Certification documentation available on request.
Data transfers over NFC directly to your device. Nothing routes through external servers — no vendor lock-in, no HIPAA business associate agreement needed for the sensor itself.
The on-device record is non-modifiable without physical access to the device. Exported CSVs include device serial number and timestamp — auditor-ready without additional processing.
These are the standards auditors cite most often in the industries Exposensia serves. Each framework's core documentation requirement is satisfied by on-device data the sensor already captures.
Requires a continuous monitoring device recording at ≤30-minute intervals with min/max excursion logging. Tempest 100 satisfies all three requirements: configurable intervals, full time-history with min/max, and tamper-evident on-device record.
Recommended device: Tempest™ 100
FDA GMP storage requirements and USP Good Storage and Distribution Practices specify Mean Kinetic Temperature (MKT) as the accepted methodology for evaluating drug product exposure. Exposensia calculates MKT on-device using ICH Q1A activation energy — no external software required to produce the value.
Recommended devices: Tempest™ 100, Tempest™ 200
WHO cold-chain guidelines for vaccines and biologics require continuous temperature logging with a tamper-evident audit trail. The on-device log, non-modifiable without physical sensor access, satisfies the tamper-evidence requirement without a cloud validation process.
Recommended device: Tempest™ 100
Requires documented monitoring of temperature-sensitive storage areas as part of a food safety plan. Tempest sensors provide timestamped, exportable records suitable for inclusion in FSMA monitoring documentation and corrective action records.
Recommended device: Tempest™ 200
HACCP plans require documented monitoring records at defined CCPs. Tap-to-export logs with timestamps and min/max values serve as monitoring records for temperature CCPs without requiring manual transcription or cloud upload.
Recommended devices: Tempest™ 100, Tempest™ 200
FDA Food Code requires holding temperatures to be verified and documented. Continuous logging replaces manual temperature logs, eliminating transcription error and providing a denser record than staff-recorded spot checks.
Recommended device: Tempest™ 100
Many state cultivation licenses require documented environmental monitoring records as part of facility compliance. Continuous temperature and humidity logs support license renewal documentation and state inspection readiness.
Recommended device: Tempest™ 200
Integrated Pest Management programs and pesticide application records increasingly require environmental condition data (temperature, humidity) at time of application. Tap-to-read logs provide the contemporaneous record without a manual entry process.
Recommended device: Tempest™ 200
Third-party food safety audits (SQF, GlobalG.A.P., USDA GAP) require documented evidence of temperature control in post-harvest storage. Continuous logs with exportable records satisfy the documentation requirement and reduce audit preparation time.
Recommended devices: Tempest™ 100, Tempest™ 200
Most monitoring solutions add a third-party data handler between the sensor and your records. That creates data governance questions most compliance officers would rather avoid.
Because Exposensia never handles patient data — or any data — on your behalf, there is no covered entity relationship to establish. The sensor is a measurement device, not a data processor.
Cloud monitoring services can revoke access to historical data when a subscription lapses. With Exposensia, the record lives on-device and in the exports you've already saved — it is yours, permanently, with no ongoing fee.
Every data point flows directly from the sensor to your phone over NFC. No network hop, no vendor API, no intermediary. The chain of custody for the record is: sensor → your device → your export. Full stop.
Download datasheets to include in vendor qualification forms, purchasing requests, or compliance documentation packages.
Temperature logger with MKT. The pharmaceutical cold-chain baseline.
We're happy to discuss how Exposensia data fits your compliance documentation process — whether that's a vendor questionnaire, an audit checklist, or a QA review.