Experiences with Validating KNIME and GAMP 5

KNIME Analytics Platform
1

Hi everyone,

I’m curious if anyone has attempted to validate KNIME according to GAMP 5 guidelines. I discovered that KNIME is certified ISO 27001, which gives me hope that someone has already created a CSV (Computer System Validation) document. I find the software fantastic and would love to incorporate it into my work in the pharmaceutical industry.

Any insights or experiences would be greatly appreciated!

Thank you!

2

@steffen_KNIME is there an additional site about these certificates. Could be beneficial.

3

Hi @Clavem and @mlauber71,

  1. At least KNIME has not yet attempted to validate against GAMP 5. Interesting, I have not heard of it before.
  2. Yes, we have a trust page: KNIME Trust Center | KNIME and are ISO 27001 certified.

Best regards
Steffen

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