Calibration
Calibration is the process of comparing a sensor's readings against a known reference standard to ensure accuracy and regulatory compliance.
What is 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.
Why It Matters
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.
Frequently Asked Questions
How often should data loggers be calibrated?
Most regulatory frameworks require annual calibration. However, critical applications may require more frequent calibration (e.g., every 6 months). The calibration interval should be defined in your quality management system based on risk assessment.
What is NABL calibration?
NABL (National Accreditation Board for Testing and Calibration Laboratories) is the Indian accreditation body for calibration labs. NABL-accredited calibration provides internationally recognised traceability, satisfying regulatory requirements in India and globally.
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