NATA

Home

OECD Principles of GLP - Advisory Document No. 17

This article was originally published in QASAR No 136 July 2016. This is the Members Magazine for the Research Quality Association (RQA). It is reproduced here with permission of the author, Mark Goodwin, Good Laboratory Practice Committee Chairman of RQA.

OECD Advisory Document No. 17 on the Application of GLP Principles to Computerised Systems was issued 22 April 2016 and is available on the OECD website.

It was refreshing to see that industry comments on the draft were considered and some changes made (for example relating to Study Director (SD) responsibilities). Some key points from the final document are:

  • The scope includes all computerised systems from simple devices (e.g. balances) to complex systems (e.g. LIMS) used for the generation, measurement, calculation, assessment, transfer, processing, storage or archiving of data. 
  • Formal qualification rather than validation may be acceptable for low complex or small systems (e.g. electronic pipettes, balances, photometers).
  • Risk management should be applied throughout the life cycle of a computerised system (e.g. to determine extent of validation).
  • Validation should include functions that may be used in non-GLP studies that might interfere with the use of the system in GLP studies.
  • QA should be aware of GLP-relevant computerised systems and verify the valid use of such systems. QA programme should verify standards are met for all phases of a system’s life cycle (with specific mention of review of audit trails).
  • During inspection of studies, quality assurance should have access to the system. A system should be in place for risk-based review of audit trail functions, its settings and the recorded information.
  • If data are printed to represent raw data, all electronic data including derived data and metadata should be printed.
  • Configuration should be known at any point during the system’s life cycle. The documented compliance of an analytical instrument’s configuration with the provisions of method validation is required to demonstrate the adequacy of a computerised system in a GLP study –regardless of its complexity. 
  • Any GLP study result should be traceable to the relevant and validated system configuration  to allow verification of settings as provided by the study plan or the relevant method.
  • Computerised systems of less criticality and less complexity may be excluded from periodic review if the exclusion is justified based on risk.
  • User privileges should not interfere with the requirements for data integrity.
  • Computerised systems used in GLP studies should be traceable from the study plan or relevant method to the inventory.
  • In the study report the SD should identify all GLP-relevant electronic data which are subject to electronic archiving and the location of the electronic archive.

Copyright RQA