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Hi,
Is the usage of electronic signatures in Nugenesis SDMS (for bioanalytical data of Bioequivalence study) needs to be notified to FDA and other regulatory authorities before/after start of usage.
As per 21 CFR Part 11 section 11.100 (c), the usage of electronic signatures to be notified to FDA.
Is the requirement applies to electronic signatures of Nugenesis SDMS for the handling of bioanalytical chromatographic data?
Is there any similar requirement from other regulatory regions like EMA, TGA Canada etc.
please provide your valuable inputs.
Regards,
Is the usage of electronic signatures in Nugenesis SDMS (for bioanalytical data of Bioequivalence study) needs to be notified to FDA and other regulatory authorities before/after start of usage.
As per 21 CFR Part 11 section 11.100 (c), the usage of electronic signatures to be notified to FDA.
Is the requirement applies to electronic signatures of Nugenesis SDMS for the handling of bioanalytical chromatographic data?
Is there any similar requirement from other regulatory regions like EMA, TGA Canada etc.
please provide your valuable inputs.
Regards,
Complete thread:
- Usage of Electronic Signatures-Notification to RegulatoryDebbie 2010-09-29 09:49
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Usage of Electronic Signatures-Notification to Regulatory Debbie 2010-10-10 18:05
- Usage of Electronic Signatures-Notification to Regulatory paulhurleyuk 2010-10-11 17:18
- Usage of Electronic Signatures-Notification to Regulatory Debbie 2010-10-10 18:05
Ing. Helmut Schütz