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Currently when data is deleted (host for instance) or changes are done in the configuration, there is no traceability of what has been deleted or changed within the whole console. It would be better to have traceability of what record/setting has been changed or deleted (old value and new value). This is to comply with EU GMP volume 4 Annex 11 & US FDA 21 CFR Part 11.
Thank you
Feb 01, 2021 01:32 AM
Hello,
Thanks for reporting this and we are currently checking this internally and will get back to you.
Regards,
Raheel
Feb 03, 2021 02:06 AM