The Systems Behind Reliable Laboratory Data
Laboratory hardware is valuable when it is suitable for its intended measurement and supported by records that explain its condition, configuration and use.
Fitness for Intended Use
Equipment should be selected according to the type of information it must produce, the required measurement range and the limits of the method.
A more complex system is not automatically more appropriate; suitability depends on the defined analytical purpose.
Qualification and Calibration
Qualification provides documented evidence that a system is installed and functioning as expected within its defined scope.
Calibration compares relevant measurements with an appropriate reference and should be performed at justified intervals.
Maintenance and System Status
Routine maintenance helps preserve equipment condition and should be recorded so users can understand when work was completed.
Systems that are unavailable, under review or outside an accepted status should be clearly identified.
Data Integrity
Instrument data should remain attributable, legible and connected to the relevant sample and method records.
Access controls, audit information and managed data storage help preserve the context needed for later review.