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Back to the forum  Query: 2017-12-12 22:54 CET (UTC+1h)
 
raghavendra_s
Regular

2010-06-21 10:02

Posting: # 5545
Views: 3,362
 

 Guidance on document management system [GxP / QC / QA]

Dear Madam/sir,

May I know if any specific regulatory guidances for industry are available on document management system/software apart from 21 CFR Part 11.

Thanks and regards,
Ohlbe
Hero

France,
2010-06-21 10:24

@ raghavendra_s
Posting: # 5546
Views: 2,859
 

 Guidance on document management system

Dear Raghavendra,

Have a look at the OECD consensus document from 1995 and at the PIC/S document from 2007 (also referred to by EU GCP inspectors).

Regards
Ohlbe


Edit: URLs updated. [Helmut]

Regards
Ohlbe
tempa
Junior

India,
2017-08-02 02:32

@ raghavendra_s
Posting: # 17645
Views: 635
 

 Guidance on document management system

Hello,

Do this rules and regulations may vary from the region or state where we live or according to the profession that we have....


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
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