The Eupry Glossary

• Alarm verification: A documented test proving that alarm thresholds, delays, notifications, and escalation work as intended. Typically performed during OQ and reverified at defined intervals.

• Audit trail: A secure, chronological record of actions in a system. Critical for data integrity and traceability.

• CAPA: Corrective and preventive action. Steps taken to fix and prevent quality or compliance issues.

• Deviation report: A document that records any non-conformance, including what happened and how it was handled.

• ALCOA plus: Expanded data integrity principles – crucial for audit acceptance.

• Data access control: System permissions that restrict data access based on roles. Helps prevent unauthorized changes.

• Temperature excursion: Any period where a monitored point goes outside defined limits. Excursions must be detected, documented, investigated, and linked to corrective and preventive actions.

• Accuracy vs. precision: Accuracy describes how close a measurement is to the true value. Precision reflects how consistently repeated measurements fall close to each other. Both are crucial for validation and audit defensibility.

• As found/as left: Calibration results recorded before and after adjustment. Helps show drift over time and whether a probe was brought back within tolerance.

• Calibration certificate: Official proof that a device (like a logger) has been tested and meets accuracy standards.

• Calibration interval: The time between required calibrations. Too long – risk of drift; too short – wasted resources.

• CMC/UCMC: Calibration Measurement Capability or Uncertainty of Measurement Capability - the best achievable measurement uncertainty of a calibration process.

• DCR – digital calibration request: An electronic form or process used to request calibration, minimizing delays and manual paperwork.

• DCC – digital calibration certificate: A digitally signed certificate proving a device has been calibrated, complete with traceability data.

• Digital mapping software: Specialized software for planning, executing, and documenting temperature mapping studies digitally. Built to meet GxP requirements and minimize manual errors. Learn more about mapping software.

• ISO 17025 accredited calibration: Calibration performed by a lab accredited under ISO 17025, ensuring technical competence and traceable, reproducible results. Learn more about ISO 17025 calibration.

• NIST calibration: Calibration traceable to the standards of the National Institute of Standards and Technology (NIST). Often a requirement for multinational pharma clients.

• On-the-wall calibration: On-site calibration method enabled by technology that makes it possible to perform calibration directly at the temperature-controlled unit of facility. Can typically be completed in minutes. Learn about the on-the-wall calibration approach.

• Probe assignment: Traceable link between a calibrated probe or logger ID and its physical location or use. Certificates and monitoring records must reference the same unique IDs.

• Quality dashboards: Unified digital interfaces providing visibility into alarms, calibration status, and monitoring trends across multiple locations. Supports proactive quality control and audit readiness.

• Traceability: The ability to trace a calibration result back to a national or international standard. Confirms the reliability of measurements.

Learn more about how you can save uo to 95% of the time you spend on calibration with Eupry's on-the-wall calibration.

• CIP skid: Standalone CIP unit containing tanks, pumps, valves, and controls for delivering and recovering cleaning solutions across multiple process lines.

• Clean–in–place (CIP): Automated cleaning process for internal equipment surfaces without disassembly, using controlled rinsing, detergent washing, and final rinsing to validated GMP limits. Learn more about clean-in-place (CIP) in pharma*

• Cleaning validation: Documented process demonstrating that cleaning procedures remove residues to MACO or HBEL acceptance limits, including validated sampling and analysis.

• Dryness fraction: Indicates how much of the steam is usable (dry) vs. water. Impacts sterilization efficiency.

• F zero value: A calculated value that measures sterilization efficacy over time. Central to validating steam sterilization.

• Health–based exposure limit (HBEL): Safe exposure level for a substance used as a basis for cleaning validation acceptance criteria.

• Maximum allowable carryover (MACO): The maximum amount of product residue allowed to carry over into the next batch without risk to patient safety, calculated from toxicological data.

• Non-condensable gases: Air or gases in steam that reduce sterilization performance. Must be monitored and controlled.

• Riboflavin coverage test: Visual method to verify CIP spray device coverage using riboflavin solution and UV light inspection. Also see: How to design CIP systems for pharma and biotech?*

• Spray device: Component of CIP systems that distributes cleaning solution inside tanks or piping, such as spray balls or rotary jet heads.

• Steam-in-place (SIP): Automated sterilization process using saturated steam after cleaning to eliminate microorganisms, achieving a validated sterility assurance level (SAL). See full guide: Complete guide to steam-in-place (SIP) validation in GxP*

• Steam quality: A measure of how effectively steam can transfer heat. High-quality steam improves sterilization outcomes.

• Steam trap: A device that removes water from steam lines. Ensures consistent temperature and sterilization quality.

• Sterility assurance level (SAL): Probability of a single viable microorganism surviving a sterilization process; typically 10⁻⁶ for GMP sterilization like SIP.

Also see: Complete guide to steam-in-place (SIP) validation in GxP

• Absolute pressure: The total pressure measured relative to a perfect vacuum. Relevant in CRYO storage or altitude-affected validation.

• Data logger: A sensor device that records environmental data like temperature over time. Used in monitoring and mapping. Learn more about wireless data loggers built for GxP.

• Differential pressure: The pressure difference between two points, used in cleanroom environments and critical zone containment.

• External sensor: Any sensor connected to a data logger to monitor additional points—inside units, deep within loads, or in risk zones. Get an overview of Eupry's full GxP sensor selection here.

• Logger fittings: Accessories (e.g., clamps, holders) used to secure loggers during mapping to ensure stable readings.

• PT100/PT1000: High-accuracy resistance temperature detectors (RTDs). PT1000 offers better noise immunity in long cables. Often used in ultra-low or high-accuracy validation setups.

• Representative load: Items placed in a unit during mapping to mimic real thermal mass and airflow impact. Often includes product dummies or filled packs.

• Thermocouple: A sensor made of two metals that generates a voltage proportional to temperature. Common in high-accuracy validations.

• Transmitter: Sends sensor data to a central system. Key in real-time monitoring setups.

• Wireless data logger: A logger that transmits data via Wi-Fi or radio, often in real time. Reduces manual work and supports automation. Learn more about wireless loggers.

• Digital validation: Using digital tools and software to plan, execute, and document validation activities. Speeds up audits and standardizes processes.

• Automated calibration: A process that uses technology to handle calibrations without manual steps – often faster, with fewer errors.

• Digital reporting: Auto-generated compliance reports you can export and present during audits. Cuts down audit prep time.

• Central dashboard: A single interface showing data across sites and devices. Useful for quality teams managing multiple units or locations.

• Unified temperature compliance: A streamlined approach that combines monitoring, mapping, and calibration in one process to reduce error and inefficiency. Learn why and how to unify your compliance.

• Excursion evaluation: Process of assessing the impact of a temperature deviation using MKT within USP <1079.2> windows. Every excursion must be documented. See also deviation handling

• Excursion limits: Regulatory thresholds for excursions as defined in USP <1079.2>. Example: MKT ≤ 25 °C over 30 days for CRT.

• Mean kinetic temperature (MKT): Calculated value expressing the cumulative effect of temperature fluctuations on a drug product. Central to USP <1079.2> excursion evaluation.

• GxP: A set of quality guidelines and regulations covering Good practices (like manufacturing, distribution, and lab work) in life sciences. These rules help ensure that products are safe, consistent, and traceable. GxP is an umbrella term for more specific practices like GMP and GDP. Learn more about GxP compliance.

• GMP: Stands for Good Manufacturing Practice. It ensures products are consistently produced and controlled according to quality standards. GMP covers manufacturing processes, equipment, and documentation.

• GDP: Good Distribution Practice. Ensures that pharmaceutical products are stored and transported under appropriate conditions to maintain quality and integrity throughout the supply chain. Learn more about GDP compliance.

• GLP: Good Laboratory Practice. Ensures the consistency, reliability, and integrity of non-clinical lab studies – often in R&D or product safety testing.

• ALCOA plus: A framework for data integrity. It stands for Attributable, Legible, Contemporaneous, Original, and Accurate – with added expectations like Complete, Consistent, Enduring, and Available. Ensures trustworthy data during audits and regulatory reviews.

• Cargo deck zones: Defined areas within an aircraft - upper deck, lower hold, door zones - monitored during aircraft mapping to detect thermal variation.

• Cold chain: The end-to-end temperature-controlled supply chain. Ensures product safety from manufacturing to delivery.

• Controlled temperature unit: Any storage or transport unit (like a fridge or truck) designed to maintain specific temperature ranges.

• Ambient monitoring: Observing temperature and humidity in spaces not actively cooled (like warehouses). Still important for product safety.

• Shipping validation: Testing and documenting that a shipment can maintain required conditions. Often needed for regulatory approval.

• CEIV Pharma: A certification that confirms an organization meets GDP requirements for air cargo pharma transport. Learn more about CEIV Pharma certification.

• GDP compliance: Meeting the standards of Good distribution practice – especially critical in pharma logistics.

• Handover documentation: Records and responsibilities maintained during cargo transfer or short-term storage to uphold the chain-of-custody in pharma logistics. See warehouse compliance examples.

• Unit Load Device (ULD): A container or pallet used to transport pharmaceutical cargo in aircraft; categorized as active (temperature-controlled) or passive (non-powered), where passive ULDs require validation via mapping. Learn more about ULDs.

• Pharma-ready: A term used to describe operations, systems, or facilities that meet the specific regulatory and quality expectations of the pharmaceutical industry. Often implies GxP alignment, audit-readiness, and validated equipment.

• Product supply: The logistics and quality-controlled delivery of pharmaceutical goods. Encompasses everything from manufacturing release to storage and distribution.

• Pharma client expectations: The compliance, validation, and data transparency standards expected by pharmaceutical customers. Critical for logistics and service providers aiming to work with pharma.

• Clinical trial supply chain: The controlled, often global distribution of investigational medicinal products (IMPs) used in clinical studies. Requires rigorous temperature monitoring and traceability.

• Regulatory inspections: On-site evaluations by authorities (e.g., FDA, EMA) to assess compliance with pharmaceutical regulations. Passing is essential to maintain licenses and market access.

• Pharmaceutical quality systems: The set of policies, SOPs, validations, and controls designed to ensure consistent product quality in pharma manufacturing and distribution.

Alarm acknowledgement: The action of confirming receipt of an alarm. Systems should log who acknowledged and when, and continue escalation if no action is taken.

Alarm delay: A configured time buffer before an alarm triggers to avoid false alerts during brief events like defrost cycles or door openings. Must be justified and documented.

• Alarm strategy: A documented plan for setting alarm thresholds, defining responsibilities, escalation steps, and deviation documentation. Helps reduce false alerts and ensures GxP alignment. Read more.

• Alert thresholds: The limits (e.g., max/min temperature) that trigger alarms when exceeded. Crucial for product safety and compliance.

• Audit-ready monitoring data: Monitoring output that is complete, timestamped, and retrievable. Structured to meet GxP and regulatory expectations for audit trails.

• Data integrity: The assurance that monitoring data is complete, accurate, and unchanged. Key for audits and regulatory acceptance.

• Drift: The gradual change in the accuracy of a sensor over time. Even high-quality sensors drift and must be calibrated regularly to maintain traceability and audit-readiness.

• Deviation handling: A structured way to respond when conditions fall outside thresholds. Includes documenting, investigating, and resolving the issue.

• Escalation path: Defined sequence of people and channels that receive alarms if earlier recipients do not respond. Reduces single points of failure.

• Excursion management: Process covering detection, initial response, product impact assessment, documentation, and CAPA for temperature excursions. Should be built into SOPs.

• Monitoring: The process of continuously observing temperature, humidity, or other environmental parameters to ensure compliance. Learn more about temperature monitoring in GxP.

• Monitoring system: A digital setup that collects, stores, and displays temperature (and sometimes humidity) data from sensors in real time. It's the backbone of compliance visibility and proactive alerting. Systems must meet GxP and audit standards. Learn more about monitoring systems.

• Real-time monitoring: Continuous tracking of temperature or humidity using connected sensors. Enables immediate alerts and audit readiness. Learn more about temperature monitoring.

• Trend review cadence: A scheduled process for reviewing monitoring data, often monthly or quarterly, to refine sensor placement and thresholds based on trends and excursions.

• Annex 11: Guidelines for the use of computerized systems in GxP environments within the EU. While not legally binding like 21 CFR Part 11 in the US, Annex 11 sets out expectations for data integrity, validation, and risk management when using digital systems in regulated processes. Especially relevant for selecting compliant monitoring systems.

• Annex 15: A part of EU GMP guidance outlining expectations for qualification and validation. It defines principles for equipment, systems, and processes to be fit for purpose.

• ATEX: EU directive covering equipment and protective systems intended for use in potentially explosive atmospheres. Critical for data loggers and sensors used in facilities storing volatile APIs or chemicals.

• DIN 13277: German standard defining performance and test requirements for medical refrigerators, including setpoints, alarms, recovery times, and functional checks. Useful as a benchmark for pharma refrigerators. See thermal compliance requirements for pharmaceutical refrigerators.

• ICH Q9: A global guideline on quality risk management. Encourages risk-based approaches to decision-making in pharma processes and validation.

• FDA: The US Food and Drug Administration. Sets regulations and enforces compliance for drugs, devices, and food in the United States.

• FDA 21 CFR Part 11: A regulation from the U.S. FDA defining criteria under which electronic records and signatures are considered trustworthy and equivalent to paper records. Ensures digital records and e-signatures in your temperature compliance system are reliable and audit-ready. Read more about Part 11 compliance.

• EMA: European Medicines Agency. Oversees evaluation and supervision of medicines in the EU, including GMP/GDP compliance.

• EU GMP Annex 15: EU guidance on qualification and validation, including cleaning validation, revalidation, and change control requirements in pharma manufacturing.

• ISO 17025: International standard for testing and calibration labs. Confirms lab competence, technical validity, and traceability. Learn more about ISO 17025 calibration.

• MHRA: UK's Medicines and Healthcare products Regulatory Agency. Ensures that medicines and medical devices meet applicable standards.

• NIS2 Directive: A European cybersecurity directive that sets new standards for digital resilience in essential sectors, including pharmaceuticals. Applies to systems storing or transmitting GxP data and requires documented risk management and breach reporting.

• USP <1079>: Guidance on good storage and distribution practices for drug products. Covers temperature-controlled storage, handling, and risk management from warehouse to point of use. See thermal compliance requirements for pharmaceutical refrigerators.

• USP <1079.2>: Defines how to evaluate temperature excursions using mean kinetic temperature (MKT). Provides calculation windows, excursion thresholds, and documentation requirements for GDP/GMP compliance. Learn more here “USP <1079.2> explained”.

• USP <1079.3>: Provides guidance on risk management for the storage and distribution of drug products, including assessing excursion impact.

• USP <1079.4>: Gives recommendations for temperature mapping of storage areas and units, including study design, sensor placement, and acceptance criteria.

• WHO TRS 961: World Health Organization technical report with practical guidance on temperature-controlled storage, mapping design, sensor placement, and monitoring for pharmaceutical facilities and units. Also see: What are the WHO’s guidelines for temperature mapping?

• Controlled ambient (20–25 °C): Narrow room‑temperature range used where tighter control than CRT is required. Common in pharma SOPs.

• Controlled cold temperature (CCT) (2–8 °C): Pharmacopeial term for refrigerated storage. Use Refrigerated (2–8 °C) for everyday language; keep CCT as a synonym for search.

• Controlled room temperature (CRT) (approx. 20–25 °C): Standard room‑temperature storage with defined excursion allowances.

• Frozen (−20 °C): Defined frozen storage (freezer). Often written as Frozen (−20 °C) in SOPs.

• Refrigerated (2–8 °C): Common industry term for +2 to +8 °C storage; equivalent to CCT.

• Ultra‑low temperature (ULT, −70 to −90 °C): Ultra‑low or deep‑frozen storage used for advanced biologics. Often referred to by setpoint (e.g., −80 °C).

Also see Temperature monitoring guidelines for GxP..

• Ambient storage (15°C to 25°C): Often overlooked, but critical for many tablets and finished goods. Deviation monitoring in ambient zones is increasingly expected by auditors.

• CRYO: Ultra-low temperature conditions below -130°C, often achieved using liquid nitrogen. Requires specialized monitoring due to extreme sensitivity and regulatory scrutiny.

• CTU – container transport unit: A mobile unit or container used to transport temperature-sensitive products, requiring pre- and post-transport validation and monitoring.

• Frozen storage (−20°C): Used for enzymes, some vaccines, and APIs. Requires GxP-compliant monitoring and calibration of freezers.

• Incubators and stability chambers: Controlled environments used for product development, testing, and stability studies. Require high accuracy, minimal drift, and constant compliance visibility.

• Pharmaceutical refrigerators: A temperature-controlled unit designed for medicines, vaccines, and biologics. Expected to maintain +2 °C to +8 °C with alarms, continuous monitoring, calibration, and audit-ready records. Learn more Pharmaceutical refrigerators: Applications, validation, and monitoring.

• Refrigerated storage (2°C to 8°C): Standard cold chain range used for most vaccines and biologics. Common across both pharma and logistics, and a key area for temperature deviation monitoring.

• TCU – temperature controlled unit: A fixed unit—such as a refrigerator, incubator, or ULT freezer—used to store pharmaceutical goods under validated temperature ranges.

• ULT – ultra-low temperature: Storage temperatures typically between -60°C and -90°C. Used for high-value biologics and vaccines. Requires detailed mapping and strict sensor accuracy due to narrow tolerance ranges.

• Aircraft temperature mapping: A process involving calibrated data loggers placed in key zones of an aircraft cargo hold to monitor thermal performance during actual flight operations. Learn more about aircraft temperature mapping here.

• Continuous mapping: An approach that keeps collecting mapping-level data over time using many loggers. Helps avoid periodic re-mapping and ensures ongoing compliance. Learn more about continuous temperature mapping and our solution.

• Defrost cycle test: Mapping test capturing temperature behavior during automatic defrost to confirm peaks stay within limits or recover within defined times.

• Door-opening test: Challenge test simulating realistic door use to verify recovery time and uniformity remain within acceptance criteria. Learn more.

• Freezer mapping: Techniques and best practices for validating ultra-low temperature units. Explore a freezer mapping guide.

• GDP mapping: A mapping study that establishes the temperature distribution within a warehouse, vehicle, or storage unit lives up to GDP requirements. Learn more about GDP mapping.

• Hot and cold spots: The highest and lowest temperature zones within a unit or space. These are critical to identify during mapping.

• Mapping data logger calculator: Use our calculator tool to estimate logger requirements for your mapping study.

• Mapping grid: A planned pattern of sensor locations that covers extremes and representative zones. Typical small fridges use a 9-point grid; larger cabinets may use 15–21 points or more, based on risk. See mapping of pharmaceutical refrigerators.

• Mapping protocol: The plan that outlines how a temperature mapping study is performed, including sensor placement, duration, and acceptance criteria. See our mapping protocol template.

• Non-conformities: Events or results that fall outside defined acceptance criteria during validation or mapping. Must be documented and resolved.

• Power-failure simulation: Controlled test to document warm-up time to limits and alarm behavior if power is lost. Results inform risk assessments and SOPs.

• Recovery time: Time required for a unit to return within defined limits after a disturbance such as a door opening or defrost. Part of acceptance criteria. See mapping of pharmaceutical refrigerators.

• Reefer temperature mapping: The process of of verifying that a refrigerated shipping container (a reefer) consitently maintains required pharmaceutical storage temperatures. Learn more about GDP-compliant reefer temperature mapping for pharmaceuticals.

• Remote mapping service: A remote-led mapping service where specialists support your team through every step – minimizing onsite workload and ensuring compliant execution. Learn more.

• Risk-based mapping: A validation method where mapping efforts focus on higher-risk areas or units. Saves time while meeting compliance. Learn more in our risk-based mapping guide.

• Risk-based re-qualification: Repeating mapping or qualification when triggered by risk events – layout changes, HVAC modifications, seasonal shifts, or alarming trends – rather than fixed intervals. Read more.

• Sensor density: Number of sensors per volume or risk level used during mapping. Determined by unit size, airflow patterns, product risk, and regulatory expectations.

• Sensor placement: Strategic positioning of loggers in high-risk or extreme zones (like hot/cold spots) to ensure accurate mapping data. See our guide on sensor placement best practices.

• Stability (control point): Allowable drift at the control sensor over time during steady-state mapping. Used alongside uniformity to judge performance.

Uniformity: Maximum allowed difference between hottest and coldest mapping points during steady state. Confirms consistent conditions across the load space. See mapping of pharmaceutical refrigerators.

• Warehouse zoning: Defining specific areas within a warehouse, such as loading bays, mezzanines, or temperature-specific rooms, each with its own mapped compliance requirements.

• Worst-case placement: A logger positioning strategy targeting areas most likely to encounter temperature extremes, such as near doors, windows, and technical installations.

• Acceptance criteria: Predefined limits that determine if a test or validation passes or fails. Critical for audit transparency.

• Change control trigger for requalification: Defined events that require repeating parts of IQ, OQ, or PQ. Typical triggers include relocation, major service, firmware updates, load profile changes, and recurring excursions.

• Cleaning validation: Documented process demonstrating that cleaning procedures remove residues to MACO or HBEL acceptance limits, including validated sampling and analysis. See full guide: Clean in place (CIP) in pharmaceuticals and biotech

• CQV (commissioning, qualification, validation): An integrated validation approach combining engineering with GxP to reduce risk and delays. Learn more about CQV validation in pharma.

• DQ: Design qualification. Verifies that equipment or systems are designed correctly and meet intended use before installation.

• IQ (installation qualification): Confirms equipment is installed per manufacturer specs and site requirements and is often the first step in GxP validation. More on IQ, OQ, PQ.

• Lane qualification: A documented validation process confirming that a specific aircraft route and compartment maintain required temperature conditions, enabling safe transport of temperature-sensitive medicines. Learn more about aircraft temperature mapping here.

• Mean Kinetic Temperature (MKT): A calculated metric that represents the aggregated effect of temperature fluctuations over time, used to assess thermal exposure during mapping studies.

• OQ (operational qualification): Verifies that equipment performs as expected under defined conditions, typically follows IQ. Explore OQ.

• PQ (performance qualification): Confirms consistent performance in real-world use - final step before commercial operation. Learn more about PQ.

• PQ with mapping: Performance qualification that includes a full mapping study under representative load and use. Confirms the unit performs as intended in real operation.

• System validation: The documented process of proving that a software or monitoring system performs as intended, reliably, reproducibly, and compliantly. It is required for all GxP-related digital tools to ensure compliance and audit readiness.

• Validation fatigue: A common issue when over-validation leads to wasted time and resources. Often caused by unclear risk prioritization.

• VMP (validation master plan): A high-level document outlining validation strategy, responsibilities, systems, and timelines.

Learn more in our thermal validation guide.

• Corrective and preventive actions (CAPA)
  Required if repeated excursions indicate poor system control. Supports GMP and GDP compliance expectations.

• GDocP
  Good documentation practices. Guidelines on how to write, update, and store records to meet regulatory expectations.

• Internal audit
  A self-check of systems and processes. Used to catch issues before external inspections.

• KPI
  Key performance indicator. A measurable value that shows how well a process or system is performing (e.g., alert resolution time).

• Nonconformity (excursion)
  Under USP <1079.2>, every excursion is a nonconforming event. Requires documentation, QA review, and justification, even if MKT is within limits.

• Quality deviation
  A documented departure from expected process or outcomes. Triggers investigations and sometimes CAPAs.

• SOP
  Standard operating procedure. A written instruction detailing how to perform a task. Ensures consistency and compliance.