AGIT

Solo in inglese.

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 and Daniel Roth: Swissmedic - Swiss Agency for Therapeutic Products
- Christoph Moor and Michael Aeschbacher: Federal Office for the Environment

Guidelines on computerized systems

• Good Laboratory Practice (GLP): AGIT – Guidelines for the Acquisition and Processing of Electronic Raw Data (PDF, 288 kB, 31.01.2018)
• Good Laboratory Practice (GLP): AGIT – Guidelines for the Archiving of Electronic Raw Data (PDF, 287 kB, 31.01.2018)
• Good Laboratory Practice (GLP): AGIT – Guidelines for the Change Management and Risk Assessment (PDF, 235 kB, 31.01.2018)
• Good Laboratory Practice (GLP): AGIT – Development and Validation of Spreadsheets (PDF, 615 kB, 31.01.2018)
• Good Laboratory Practice (GLP): AGIT – Management of electronic SOPs (PDF, 231 kB, 31.01.2018)
• Good Laboratory Practice (GLP): AGIT – Guidelines for Collaboration with external IT Service Providers (PDF, 221 kB, 31.01.2018)
• Good Laboratory Practice (GLP): AGIT – Validation of Computerised Systems (PDF, 395 kB, 31.01.2018)
• Pipette Control (ZIP, 34 kB, 31.01.2018)

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)? (PDF, 151 kB, 31.01.2018)

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? (PDF, 796 kB, 13.10.2020)

Basi legali

Ordinanza sulla buona prassi di laboratorio (OBPL)

Ultima modifica 31.01.2018