Glossary

 

Accuracy

How close a measured value is to the true value as measured by our reference standards.

 

Adjustment

Adjusting an instrument such that it measures more accurately. This is performed after a calibration.

 

Ambient Conditions

The temperature and relative humidity of the vicinity a calibration is being performed within.

 

Calibration

Comparison of a unit under test and a reference standard(s) of known accuracy. This process does not entail adjusting the unit under test should it fall out of its specification.

 

Controller

A device that interprets a digital or analogue signal and controls other components accordingly.

 

Instruments

Devices which can read sensors and display useable data accordingly. Many instruments may make up larger and more complex control systems.

 

Operational Qualification (OQ)

Documented verification by testing under controlled conditions that a system performs as specified and if fit for purpose for its intended operational ranges.

 

Out of Specification

When a unit under test does not meet either its manufacturer's specification or owners own specification due to being inaccurate or unreliable.

 

Performance Qualification (PQ)

Documented verification by testing under controlled conditions that a system performs reproducibly and as deemed appropriate for a process method and its specification.

 

Pharmaceutical product

A product intended for use as a medical drug which is presented in its final dosage and is subject to pharmaceutical legislation.

 

Sensor

An electromechanical device which generates an electrical signal depending upon the parameter it is sensing.

 

Specification

A description of a unit under test's performance with  regards to accuracy and repeatability.

 

Stability

The capability of a measuring instrument to maintain consistent readings over time.

 

Standard Operating Procedure

A common set of instructions that if followed correctly ensure that the outcome will be within certain tolerances and boundaries.

 

Thermistor

A temperature dependant variable resistor.

 

Thermocouple

A thermoelectric device consisting of two dissimilar metals joined at two points. A potential difference can be measured at the reference junction to determine the temperature at the hot junction.

 

Time and temperature sensitive pharmaceutical product (TTSPP)

A pharmaceutical product which degrades to an extent which renders it no longer fit for its intended purpose when not stored and transported in predefined conditions.

 

Traceability

Ability to trace a measurement back to an IEC/ISO 17025 calibrated reference instrument.

 

Transmitter

An instrument that provide a current output.

 

UKAS

United Kingdom Accreditation Service.

 

Validation

Documented testing performed under controlled conditions which determines whether or not a process and the methods associated produce consistently acceptable products or results, as determined by a predetermined set of criteria.