Bioequivalence and Bioavailability Forum • QC # QA

QC # QA [GxP / QC / QA]

posted by joy_fm – Indonesia, 2014-01-17 14:42 (4530 d 09:45 ago) – Posting: # 12187
Views: 25,854

Dear Mahesh M,
Thank u, I absolutely agree with your opinion.

Dear Helmutz,
Can u explain about this statement

❝ However, if data come from external sources I don’t get the point why the data-import (analytics, lab values ⇒ statistics) should not be checked 100%. Takes about one hour for an average study.

In my opinion, it will take at least two days to check 100% raw data. How to check 100% raw data in one hour ? What's your checking point ?

Best regards
Joy_fm

Edit: Standard quotes restored, post linked. [Helmut]

Complete thread:

QA Audit Procedure swapnil.kuche 2011-01-20 06:47
- QA Audit Procedure Helmut 2011-01-20 12:05
- QA Audit Procedure ElMaestro 2011-01-20 13:02
  - QA Audit Procedure Helmut 2011-01-20 14:13
    - QA Audit Procedure Ohlbe 2011-01-20 20:26
      - QC # QA Helmut 2011-01-21 04:23
        
        QC # QA swapnil.kuche 2011-01-21 05:32
        QC # QA ElMaestro 2011-01-21 13:39
        
        QC # QA Ohlbe 2011-01-23 15:18
        
        ISO17025 is King ElMaestro 2011-01-25 13:15
        QC # QA joy_fm 2014-01-15 07:55
        
        QC # QA riteshsrmc 2014-01-16 12:55
        
        QC # QA Mahesh M 2014-01-16 13:30
        
        QC # QA ElMaestro 2014-01-16 13:35
        
        QC # QA joy_fm 2014-01-16 14:55
        
        QC # QA Mahesh M 2014-01-17 12:01
        
        QC # QAjoy_fm 2014-01-17 13:42
        
        Waste of time Helmut 2014-01-17 14:16
        
        QC # QA joy_fm 2014-01-20 07:38
        
        QC # QA Ohlbe 2014-01-17 15:27
        
        QC According to ICH E3 mittyri 2014-01-20 14:29
        
        QC According to ICH E3 Helmut 2014-01-20 15:20
        
        BE Report: Recommendations to the structure mittyri 2014-01-22 18:44
        
        BE creative! Helmut 2014-01-22 20:53