Friday 1 June 2018

Revised: “Validation of Computerised Systems” Guideline

News from EDQM: Since the adoption of the first version of the “Validation of Computerised Systems” guideline in May 2009, most of the Network members have introduced computerised systems e.g. Laboratory Information Management Systems (LIMS) and electronic document management systems into their labs which have become commonly used working tools of the Network. For that reason and also based on experiences gained during Mutual Joint Audits, the guideline has been profoundly restructured and revised.

The scope for new core document states:

“This guideline defines basic principles for the validation of computerised systems used within Official Medicines Control Laboratories (OMCLs) and having impact on the quality of results, document control and data storage. The purpose of this validation is to guarantee confidence in the laboratory data captured, processed, reported or stored by computerised systems. A validated system ensures accurate results and reduces any risks to data integrity. This document applies to all types of computerised systems used in OMCLs. However, depending on their complexity, the extent of testing and documentation will differ. Computerised systems can be categorised into three types: exempted, simple and complex (see table I in section 3). This document describes a scalable validation approach for simple and complex computerised systems.”

The revised version is now organised in a core document and two annexes (instead of three annexes in the previous version). All three parts of the guideline will come into force on 1 August 2018.

For details, see: EDQM (

Posted by Dr. Tim Sandle

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