Discuss with peers about the use of supporting IT tools within GxP validation
- Are these tools to be considered GAMP Category 1? Or do they not require validation or qualification at all?
- Some tools, e.g. automated testing tools and test environments should have documented assessments for their adequacy (see Annex 11, par. 4.7). What does this mean?
We are happy that GAMP Subject Matter Expert Sion Wyn will join us in the discussion.
Registration required (free of charge). Limited seats (max. 30). Active participation is required.