Validation of an ELN or LIMS
Chan Ion
1 Posts

Has anyone had experience with the validation process of an ELN or LIMS? My team is interested in updating to a LIMS but I am overwhelmed with trying to understand what the validation process actually looks like. Any advice or guidance would be appreciated! I have reviewed FDA (21CFR Part 11) guidance documents and regulations as well as the GAMP 5 guide.

Thank you,
1 Replies
Sure have, multiple times. Is there a specific set of questions? Both work well with a GAMP5 approach.