Bioequivalence and Bioavailability Forum • Source Document: certified copies

Source Document: certified copies [GxP / QC / QA]

posted by Ohlbe – France, 2009-03-20 16:43 (6303 d 03:22 ago) – Posting: # 3385
Views: 8,583

Dear Preet,

❝ In this case where to file this form as source document; in Clincal dept

❝ or in Bioanalytical dept?

❝ Or shall we file these documents centrally as advised by you in first

❝ response without filing the photocopies in BA dept.

I would go for a central archiving. Both departments are working on the same trial, and you can have a central archive for that trial.

❝ Once again, are dated signatures needed on the photocopy?

If you want to have a copy in the bioanalytical documentation: once again, I would say no need for signatures on the photocopy. The original document will be available if anybody wants to see the source document for any reason.

Regards
Ohlbe

Complete thread:

Source Document: certified copies Preet 2009-03-19 08:22
- Source Document: certified copies Ohlbe 2009-03-19 13:43
  - Source Document: certified copies Preet 2009-03-20 06:41
    - Source Document: certified copies Ohlbe 2009-03-20 10:48
      - Source Document: certified copies Preet 2009-03-20 12:33
        
        Source Document: certified copiesOhlbe 2009-03-20 15:43
        
        Source Document: certified copies Preet 2009-03-21 05:06