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RegisterQA statement signature [GxP / QC / QA]
Hello,
I'm working for a CRO as a QA specialist and my question is the following. The QA statement is signed by the QA management for now in our company but we are reevaluating this practice and we are wondering if there is some regulatory requirements (FDA, EU, Japan...) to have the management siging this statement? We are planning to ask the auditor to sign it. What is the responsibility of the person signing this document?
Regards
Johanne
Edit: Category changed. [Helmut]
I'm working for a CRO as a QA specialist and my question is the following. The QA statement is signed by the QA management for now in our company but we are reevaluating this practice and we are wondering if there is some regulatory requirements (FDA, EU, Japan...) to have the management siging this statement? We are planning to ask the auditor to sign it. What is the responsibility of the person signing this document?
Regards
Johanne
Edit: Category changed. [Helmut]
Complete thread:
- QA statement signaturejlanteigne 2011-03-02 16:24
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- QA statement signature Ohlbe 2011-03-02 17:00
- QA statement signature jlanteigne 2011-03-02 17:45
- QA statement signature Helmut 2011-03-02 17:58
- QA statement signature jlanteigne 2011-03-02 17:45
- QA statement signature Ohlbe 2011-03-02 17:00
Ing. Helmut Schütz