Hi,
Is this system covered by FDA regulations. ER/ES 21 CFR Part 11 etc. If so what additional work is performed to make it compliant? Validation statements etc.
Thanks, Alastair
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Hi,
Is this system covered by FDA regulations. ER/ES 21 CFR Part 11 etc. If so what additional work is performed to make it compliant? Validation statements etc.
Thanks, Alastair