Can I Use Heartbeat Technology in a GMP Environment?

In-situ verification technologies such as Heartbeat Technology are becoming more common in various instruments to measure flow, level, pressure and temperature, as well as for liquid and gas analysis.

Being able to extend intervals between calibration cycles while increasing the reliability of the measuring point are just two of the many benefits driving users to make the switch from traditional calibration procedures to the more efficient way of utilising built-in verification functionality. The question remains: how do authorities accept the new paradigm and how can users pass regulatory audits?

This paper will explain how in-situ verification technologies such as Heartbeat Technology can be used even in strictly regulated industries and be a part of a CFR part 11 compliant system.