Experiences with Validating KNIME and GAMP 5

[Clavem]

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!

[mlauber71]

@Clavem

KNIME is certified ISO 27001

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

NIS 2 or ISO 27001

Dear @JacMP and @crispim, yes, KNIME has been certified according to ISO 27001since July 14th 2024. The certificate can be found here: Box | Login A trust page listing this and other information is in the making. Best regards Steffen

[steffen_KNIME]

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