GMP Inspections of Computerised Systems - Which Are the Most Frequent Deficiencies?

GMP News No. 703

GMP News
11 April 2006

GMP Inspections of Computerised Systems - 
Which Are the Most Frequent Deficiencies?

Within the framework of GMP inspections of computerised systems, national and international supervisory authorities are especially interested in systems that acquire, archive and process critical GMP data (temperature, humidity, conductivity, TOC, particles and others) in the storage, production or control of medicinal products. In case a room monitoring system is not operated appropriately, sensitive medicinal products, like blood products, are at a high risk.

Numerous, partly grave deficiencies in connection with such systems have been documented during inspections. In the following, we have listed a selection of these deviations:

  • System Configuration, Documentation

Unsatisfying configuration and documentation of systems for the acquisition of critical GMP-relevant parameters.
  • Paperless Videographic Recorders, Hybrid System
    Unclear distinction between electronic record and paper documentation (operation of hybrid systems), especially with regard to archiving and evaluation.

  • Paperless Videographic Recorders, Data Flows

  • Data integrity endangered by untraceable data flows from the acquisition of a measured value to its recording in a LIMS.
  • Monitoring System, Validation

  • Insufficient validation activities in connection with a system for temperature measurement in a cold storage leading to the preliminary rejection of the stored starting materials.
  • Data Loggers, Documentation

  • Printouts of data (graphs) based on data collected by data loggers are not precise enough to be used for a GMP-compliant evaluation.
  • Excel® Used as Evaluation Software, Data Conversion

  • The data generated by a logger were converted into the XLS format and archived without ensuring data integrity.
  • Room Monitoring System, Validation

  • The qualification and validation of the room monitoring system was insufficient. Internal calculations executed by the software in use were not comprehensible.
  • Room Monitoring System, Projecting and Archiving

  • Backup of the data acquired by the room monitoring system was not conducted according to the state of the art. A documentation of the alert and system messages could not be presented.
  • Room Monitoring System, Access Control Matrix

  • The configuration of the user settings had considerable safety defects.
  • Data Loggers, Software for Evaluation and Archiving
  • GMP-relevant setup settings of an evaluation and archiving software for data loggers were either not used or ignored.
    The following GMP seminars also focus on new Computer Systems Validation issues:
    Klaus Feuerhelm
    Office of the Tübingen Administrative District

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