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Quality by Design in Process Instrumentation

Reducing calibrations without risking product quality

Heartbeat Technology in the Life Sciences ©Endress+Hauser

This paper will explain how process automation has evolved and how instruments now offer integrated solutions such as Heartbeat Technology which facilitate the implementation of “Quality by Design” (QbD) and provide full regulatory compliance. Offering the possibility to reduce or even eliminate wet calibrations without putting product quality at risk.

Life Science Industry and Regulatory Compliance

Wet calibrations are today still the most often used method to check an instrument and demonstrate regulatory compliance. State-of-the-art instruments with embedded verification capabilities offer now the chance to change this practice.

Performing regular verification on the instrument can extend calibration cycles by a factor of 5 or higher without jeopardizing compliance. Shorter unknown periods between checks lead to an increased confidence level and reduced risk for critical applications.

In this white paper we will adress:

  • how built-in verification allows to extend calibration cycles

  • how reliable self-calibration devices are

  • what regulatory compliance has to say about self-verification instrumentation