new release of validation guide for computerised systems

Quality Management (QM) documents are available on the EDQM website. The three documents are organized in core document and two annexes. All three parts will be effective on 01.August 2018. The profoundly revised versions are better structured and help establishing the suitable qualification/validation processes. 

The following three documents relevant for LIMS implementation have been published: 

Validation of Computerised Systems - Core Document (comes into force on 1 August 2018)

Validation of Computerised Systems Annex 1: Validation of Excel Spreadsheets (comes into force on 1 August 2018)

Validation of Computerised Systems Annex 2: Validation of Complex Computerised Systems (comes into force on 1 August 2018)