Calibration

Calibration is the process of comparing a measurement instrument's readings against a traceable reference standard of known accuracy. If deviations are found, the instrument is adjusted or the deviations are documented as correction factors. Calibration ensures that the data your monitoring system records is accurate and reliable.

For regulatory compliance, calibration must be performed at defined intervals (typically annually) by an accredited calibration laboratory (such as a NABL-accredited lab in India or an A2LA-accredited lab in the US). Calibration certificates provide documented proof of accuracy for auditors.

An uncalibrated sensor might show 4°C when the actual temperature is 7°C — potentially allowing an excursion to go undetected. Regulatory standards like FDA 21 CFR Part 11, GMP, and ISO 17025 require documented proof that monitoring instruments are calibrated to traceable standards. Without valid calibration certificates, audit findings and compliance violations are inevitable.