AGIT (Arbeitsgruppe Informationstechnologie) - Swiss IT Working Group

AGIT Website

AGIT has produced a number of GLP guidance documents:

Guidelines on computerised systems 

• Good Laboratory Practice (GLP): AGIT – Guidelines for the Acquisition and Processing of Electronic Raw Data 
• Good Laboratory Practice (GLP): AGIT – Guidelines for the Archiving of Electronic Raw Data 
• Good Laboratory Practice (GLP): AGIT – Guidelines for the Change Management and Risk Assessment
• Good Laboratory Practice (GLP): AGIT – Development and Validation of Spreadsheets 
• Good Laboratory Practice (GLP): AGIT – Management of electronic SOPs 
• Good Laboratory Practice (GLP): AGIT – Guidelines for Collaboration with external IT Service Providers  
• Good Laboratory Practice (GLP): AGIT – Validation of Computerised Systems 
• Pipette Control

Position paper 

• Good Laboratory Practice (GLP): AGIT – Position Paper regarding: Is it acceptable to destroy the paper originals of raw data and related study documentation, if an image of the paper is captured in an electronic form (e.g. scanned)? 

• Good Laboratory Practice (GLP): AGIT - Position Paper 2: Is a formal validation of spreadsheets used for data processing in a GLP study in any case mandatory?