ISPE GAMP COP Benelux Knowledge Café

Topic

This Café we want to have a discussion on 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?
Hopefully this discussion will give some answers to above questions.
We are happy that GAMP subject matter expert Sion Wyn will join us in the discussion. This Café will be led by Frans Boeijen and René van Opstal.

Goal

This is the second Knowledge Café of the GAMP COP Benelux, where we want to address specific questions and/or concerns around a topic. We hope to be able to share knowledge, personal practices and benchmarks through discussion on the specific topic.

The Rules

To make the Knowledge Café successful, we ask participants to agree to the rules below:

• Active participation is appreciated
• No presentations
• Enter on time, preferably 5' upfront
• Mute yourself when you're not talking
• Camera on when speaking
• Stay on topic in scope
• Be respectful
• Raise your hand if you want to respond
• Safe space

No recording available!
We start at 12:30 and end is expected at 13:30h.

Registration required. You will receive the teams invitation the day before the meeting. Please keep in mind, that this may end up in your spam folder.