AGIT
Nur in englischer Sprache.
The Working Group of Information Technology (AGIT, Arbeitsgruppe Informationstechnologie) consists of representatives of the GLP Compliance Monitoring Units and of invited experts from the industry. Several documents related to information technology in a GLP environment have been developed. These documents are considered to be interpretations of the Principles according to article 4 paragraph 2 of the OGLP.
List of the current members of the GLP Working Group on Information Technology (AGIT)
Invited experts from industry:
- Larissa Michel: Swiss BioQuant AG
- Markus Haak: F. Hoffmann-La Roche AG
- Jean-Marc Jehl: Debiopharm S.A.
- Peter Crick: Innovative Environmental Services (IES) Ltd
Members of the Swiss GLP compliance monitoring units:
- Sabine Frey: Federal Office of Public Health
- Elisabeth Klenke: Swissmedic - Swiss Agency for Therapeutic Products
- Christoph Moor and Michael Aeschbacher: Federal Office for the Environment
Guidelines on computerized systems
Guidelines for the Acquisition and Processing of Electronic Raw Data in a GLP Environment
Guidelines for the Validation of Computerised Systems
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 – Management of electronic SOPs
Good Laboratory Practice (GLP): AGIT – Guidelines for Collaboration with external IT Service Providers
Good Laboratory Practice (GLP): AGIT – Development and Validation of Spreadsheets
Pipette Control
Position paper
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?
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)?