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RegisterAuditing of CRO QA (Quality Assurance) [GxP / QC / QA]
Dear Mr. Vivekanand,
Since there would be a bias if QA is audited internally, it is recommended that QA be audited by a cross functional department or by a external/ third party auditor. This has to be well defined in the SOP. This is for the same reason as to why QA is kept independent of the operational departments (In order to avoid bias).
Regards
Srinivas
Since there would be a bias if QA is audited internally, it is recommended that QA be audited by a cross functional department or by a external/ third party auditor. This has to be well defined in the SOP. This is for the same reason as to why QA is kept independent of the operational departments (In order to avoid bias).
Regards
Srinivas
Complete thread:
- Auditing of CRO QA (Quality Assurance) vivekanand 2013-05-25 06:21
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- Auditing of CRO QA (Quality Assurance)sarada06884 2013-05-29 08:27
Ing. Helmut Schütz