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 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.
The revised guidelines are the following
- Validation of Computerised Systems - Core Document
- Validation of Computerised Systems Annex 1: Validation of Excel Spreadsheets
- Validation of Computerised Systems Annex 2: Validation of Complex Computerised Systems