Regulations concerning the handling and management of data from "small" computerised systems?

Recommendation

5-7 December 2023

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Are regulations necessary for the handling and management of data generated by small systems (e.g.  pH meters, filter integrity testers, etc.)? As a rule, GMP-relevant data must be documented. It doesn't matter if this data is generated by large or small systems. Basically, the handling of this data must be regulated.

GMP-relevant data from small computerised systems may have to be read directly from the device and written down by hand. If the system has a printer interface, this interface should also be used. This is an essential step to ensure data integrity.

This also means that when purchasing such small systems, one should already make sure that they have a printer interface. The printer ensures an independent and correct recording of the data when the system is qualified. Raw data is demonstrably available:

MHRA 'GxP' Data Integrity Guidance und Definitions from March 2018:
6.2 "In the case of basic electronic equipment that does not store electronic data,or provides only a printed data output (e.g. balances or pH meters), then the printout constitutes the raw data."

Especially with small systems, it is possible to manipulate data. Restrictive requirements for the handling and documentation of such data are mandatory.

The MHRA 'GXP' Data Integrity Guidance and Definitions document from March 2018, for example, refers to this risk:
4.3 "Within these systems, it may be possible to manipulate data or repeat testing to achieve the desired outcome with limited opportunity for detection (e.g. stand-alone systems with a user-configurable output such as ECG machines, FTIR, UV spectrophotometers)."

Source: MHRA 'GxP' Data Integrity Guidance and Definitions from March 2018