The A–Z of thermal validation

Also read: Complete guide to thermal validation

A

Acceptance criteria: The predefined specifications a system must meet to be considered validated.

Audit trail: An audit trail is a secure, chronological record of all actions taken within a compliance system - such as who performed what task, when, and why- needed for regulatory traceability.

B

Biological indicator (BI): A device containing microorganisms used to test the effectiveness of a sterilization process.

C

Calibration: Comparison of a measurement device to a standard of known accuracy (usually ISO 17025 traceable).

Calibration idle time: Downtime that occurs while waiting for sensors or equipment to be recalibrated - often a bottleneck in mapping or monitoring processes.

Cold spot: The area in a system that reaches target temperature last – typically the hardest point to validate.

Continuous mapping: Continuous temperature mapping is a method of mapping that uses a permanent setup of data loggers and continuous monitoring to eliminate the need for periodic re-mapping. It enables real-time validation and centralized quality control across facilities.

D

Design qualification (DQ): Documented verification that system design meets user and regulatory requirements. Digital validation: A streamlined approach to validation using digital tools and platforms to manage protocols, execute IQ/OQ/PQ, and store documentation - reducing manual errors and ensuring audit-readiness. Deviation handling: The documented process of investigating, correcting, and preventing temperature excursions or non-conformities in GxP environments. Often includes root cause analysis and corrective actions.

Also see: How to investigate a temperature excursion faster?

F

F₀ value: A standard unit of sterilization used to quantify the microbial killing effect of heat (121 °C/250 °F baseline).

G

Good Distribution Practice (GDP): Guidelines ensuring quality during transport and distribution of pharmaceuticals.

Good Manufacturing Practice (GMP): Regulations ensuring products are consistently produced and controlled to quality standards.

GDocP (Good Documentation Practices): A set of standards ensuring documentation is accurate, consistent, and reliable. Essential in regulated environments for audit-readiness and compliance.

I

Installation qualification (IQ): Confirmation that equipment is installed correctly per manufacturer and design requirements.

M

Mapping: Process of measuring and documenting temperature distribution in a space or unit.

Mapping protocol: A temperature mapping protocol is a pre-defined plan outlining how a study will be executed, including equipment, placement, data collection parameters, and reporting standards. Critical for GMP/GDP audits.

O

Operational qualification (OQ): Testing to confirm equipment functions within defined limits under controlled conditions.

P

Performance qualification (PQ): Validation that equipment consistently performs under real-world operating conditions.

Also read: Temperature mapping: Tips, frameworks, and pitfalls

Q

Qualification: The overall process of proving that equipment works as intended, often broken into DQ, IQ, OQ, and PQ.

R

Risk-based validation approach: A strategy to prioritize validation based on product risk, process criticality, and regulatory impact.

S

Sensor drift: Gradual deviation in a sensor’s accuracy over time, potentially impacting data integrity and compliance unless monitored and recalibrated regularly.

Sensor placement: Strategic positioning of data loggers or probes in high-risk or critical areas (e.g. near doors or cold spots).

Also read: Where to place data loggers during temperature mapping?

T

Temperature-controlled unit (TCU): Any environment or equipment (e.g., refrigerators, warehouses, vehicles) designed to maintain specific temperature ranges critical for storing or transporting sensitive products.

Thermal validation: Documented proof that equipment maintains required temperature conditions reliably and consistently.

Also read: What is thermal validation?](/thermal-validation/what-is-thermal-validation)

V

Validation fatigue: A common term in pharma logistics and quality teams referring to the recurring disruptions, workload, and operational delays caused by frequent re-mappings or complex IQ/OQ cycles.

Validation Master Plan (VMP): A document outlining your entire validation strategy, approach, and responsibilities.

W

Wireless data logger: A wireless or Wi-Fi data logger is a device that transmits data via Wi-Fi, bluetooth, or similar, allowing for remote monitoring and real-time alerts.