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RegisterAuditing vs. Monitoring [GxP / QC / QA]
Dear M. Vasu,
Let's say that the head of monitoring and the head of QA can report to the same person within senior management. But monitoring and auditing teams should report to different heads. Have a look at ICH GCP § 5.19.1:
The purpose of a sponsor's audit, which is independent of and separate from routine monitoring or quality control functions...
❝ Monitoring and Auditing teams can report to same person or not.
Let's say that the head of monitoring and the head of QA can report to the same person within senior management. But monitoring and auditing teams should report to different heads. Have a look at ICH GCP § 5.19.1:
The purpose of a sponsor's audit, which is independent of and separate from routine monitoring or quality control functions...
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Auditing vs. Monitoring M.Vasu 2014-12-29 04:16
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Auditing vs. MonitoringOhlbe 2015-01-05 12:20
Ing. Helmut Schütz