Glossary
Cold Chain & Compliance Glossary
Clear, factual definitions of the terms used across temperature monitoring and regulated cold chains.
ALCOA+
ALCOA+ is a set of data-integrity principles requiring records to be Attributable, Legible, Contemporaneous, Original and Accurate, plus Complete, Consistent, Enduring and Available.
ALCOA+ is the data-integrity framework regulators apply to GxP records. Monitoring data meets it when each reading is attributable to a user or device, captured contemporaneously at the moment of measurement, kept original and tamper-evident, and remains legible, accurate, complete and available throughout its retention period.
→ GMP complianceAudit trail
An audit trail is a secure, time-stamped, computer-generated record of system events and user actions that create, modify or delete data.
In a monitoring system, the audit trail records who did what and when — configuration changes, alarm acknowledgements, report exports and the underlying measurements. A tamper-evident audit trail is central to GDP, GMP and FDA 21 CFR Part 11 because it lets an inspector verify that records have not been altered.
→ Audit & ReportingCalibration
Calibration is the documented comparison of a sensor's readings against a traceable reference standard to confirm and certify its accuracy.
Seemoto sensors are factory calibrated before delivery, each with an individual, digitally accessible calibration certificate. Recalibration on a schedule defined by your quality system is offered as a professional service and produces an updated, traceable certificate. Calibration status appears on compliance reports so auditors can confirm devices were in tolerance.
→ Calibration ServiceCold chain
The cold chain is the uninterrupted series of temperature-controlled storage and transport steps that keep a sensitive product within its required range from production to point of use.
A cold chain spans manufacturing, warehousing, transport and final storage. Any break — a failed chiller, a long door-open event, an unrefrigerated transfer — can compromise vaccines, medicines, biological samples or food. Cold chain monitoring provides the continuous evidence that the chain was never broken.
→ Cold chain monitoring basicsCritical Control Point (CCP)
A Critical Control Point (CCP) is a step in a food process where control can be applied to prevent, eliminate or reduce a food-safety hazard to an acceptable level.
CCPs are the backbone of a HACCP plan. For temperature-based hazards, a CCP might be a chiller, a blast freezer or a delivery vehicle. Each CCP has a defined critical limit, and continuous monitoring with alerting demonstrates that the limit is held — automating HACCP principles for monitoring, corrective action and record keeping.
→ HACCP complianceCryogenic / LN₂ storage
Cryogenic storage holds biological materials at ultra-low temperatures, typically around −196 °C using liquid nitrogen (LN₂).
Cells, embryos and tissue are often stored in LN₂ tanks at about −196 °C. Monitoring requires cryo-rated PT-1000 probes and redundant configurations, because a drop in nitrogen level or an equipment failure can damage irreplaceable samples before a standard alarm would react.
→ Cryogenic LN2 Tank MonitoringData logger
A data logger is a device that records temperature (and sometimes humidity) readings to internal memory for later download, without needing continuous connectivity.
Loggers are ideal for shipments and sea freight where there is no gateway in transit: they record throughout the journey and the data is downloaded on arrival. Wireless sensors, by contrast, transmit continuously for live dashboards and real-time alerts. Many operations use both.
→ Low-Cost DataloggingEN 12830
EN 12830 is the European standard specifying performance, testing and suitability requirements for temperature recorders used in the transport, storage and distribution of temperature-sensitive goods.
The current edition, EN 12830:2018, covers the full recording system across −80 °C to +85 °C and defines measurement-error, response-time and recording-accuracy requirements. Seemoto temperature sensors and loggers are designed and certified to EN 12830.
→ EN 12830 complianceFDA 21 CFR Part 11
FDA 21 CFR Part 11 is the US FDA regulation defining when electronic records and electronic signatures are considered trustworthy and equivalent to paper.
Part 11 requires secure, attributable electronic records, a complete audit trail, tamper-evident storage and controlled access. Seemoto supports compliant Part 11 workflows; formal system validation, which demonstrates Part 11 compliance for a specific installation, is a separate professional service.
→ FDA 21 CFR Part 11Gateway
A gateway is the device that collects readings from nearby wireless sensors and forwards them securely to the cloud over GSM, Ethernet or Wi-Fi.
Gateways are the bridge between sensors and the monitoring platform. GSM gateways with their own SIM connect without relying on customer IT infrastructure, and sensors buffer data locally so nothing is lost if a gateway briefly goes offline.
→ Sensors & GatewaysGDP (Good Distribution Practice)
GDP is the set of standards governing how medicinal products are stored, transported and handled so their quality and integrity are maintained across the distribution chain.
In the EU, GDP for human medicines is defined by guidelines 2013/C 343/01. It requires continuous temperature control, temperature mapping, documented audit trails, prompt deviation handling and retrievable records. Seemoto supports these requirements through continuous monitoring and audit-ready reporting.
→ GDP complianceGeofencing
Geofencing uses GPS location to define virtual boundaries that automatically trigger events such as shipment departure, arrival or route-deviation alerts.
In shipment monitoring, geofences detect when a package leaves the origin or reaches its destination without manual scanning, and flag delays or off-corridor movement. Combined with temperature data, this builds an automated chain-of-custody record.
→ Shipment MonitoringGMP (Good Manufacturing Practice)
GMP is the quality framework ensuring regulated products are consistently produced and controlled to the standards appropriate to their intended use, including environmental monitoring.
GMP emphasises data integrity (ALCOA+), calibrated measurement, controlled access and documented deviation handling in production, storage and cleanroom areas. Seemoto supports GMP environmental monitoring; validation (IQ/OQ/PQ) is a separate professional service.
→ GMP complianceGxP
GxP is an umbrella term for the family of 'good practice' quality regulations, including GMP, GDP, GLP (laboratory) and GCP (clinical) practice.
When a requirement applies across several of these frameworks it is often described as 'GxP'. Monitoring evidence — continuous data, audit trails and controlled access — supports the shared data-integrity expectations across all GxP domains.
→ IQ, OQ & PQ ServicesHACCP
HACCP (Hazard Analysis and Critical Control Points) is a preventive food-safety management system that identifies hazards and controls them at critical control points.
Codified by the Codex Alimentarius, HACCP's seven principles require setting critical limits, monitoring, corrective action and record keeping. For temperature-based CCPs, continuous automated monitoring with alerts and audit-ready records directly supports principles 3 through 7.
→ HACCP complianceIQ / OQ / PQ
IQ, OQ and PQ are the three formal validation stages — Installation, Operational and Performance Qualification — that document evidence a system is fit for regulated use.
Installation Qualification verifies the system is installed to specification; Operational Qualification confirms it works within defined parameters; Performance Qualification proves it performs reliably under real conditions. With Seemoto, IQ/OQ/PQ documentation is a separate, scoped professional service — it is not bundled into the standard subscription.
→ IQ, OQ & PQ ServicesMean Kinetic Temperature (MKT)
Mean Kinetic Temperature (MKT) is a single calculated temperature expressing the cumulative thermal stress of a varying temperature profile over time.
MKT lets a fluctuating real-world exposure be compared meaningfully against a product's stability data — more informatively than a simple average — and is widely used in temperature-excursion impact assessments to support release-or-reject decisions.
→ Managing temperature excursionsReal-time alert
A real-time alert is a notification sent the moment a sensor reading crosses a configured threshold, as distinct from the routine logging interval.
It is worth distinguishing the two. Seemoto logs readings continuously at a default 5-minute interval (configurable to 1 minute), while alerts for threshold breaches are delivered in real time by SMS, email and app, with multi-tier escalation. So 'real-time' refers to alerting and live visibility, not sub-minute logging.
→ Dashboard & Mobile AppTemperature excursion
A temperature excursion is any period during which a product is exposed to conditions outside its labelled or validated storage range.
Excursions vary in severity by magnitude and duration. Handling one involves prompt detection, containment, an impact assessment using stability data and Mean Kinetic Temperature, a disposition decision by a qualified person, and full documentation.
→ Managing temperature excursionsTemperature mapping
Temperature mapping is a structured study that measures how temperature is distributed across a space over time to identify hot spots, cold spots and gradients.
Mapping qualifies a warehouse, cold room or vehicle before use and after significant changes, and determines where permanent monitoring sensors should be placed. It is a point-in-time study that informs — but does not replace — continuous monitoring.
→ Temperature mapping guideUltra-low temperature (ULT) freezer
A ULT freezer is a freezer that maintains ultra-low temperatures, typically around −80 °C, used for biological samples, vaccines and reagents.
Materials stored at −80 °C are often irreplaceable, so ULT monitoring uses high-accuracy PT-1000 probes and multi-tier alarm escalation to ensure any deviation is acted on before sample integrity is lost.
→ Ultra-Low Freezer MonitoringGo deeper
Read the full guides, or see how Seemoto supports each compliance framework.