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.
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)
Ultima modifica 31.01.2018