Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-07-20 11:00 CEST (UTC+2h)
raghavendra_s
Regular

2010-06-21 10:02

Posting: # 5545
Views: 4,094
 

 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: 3,491
 

 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: 1,268
 

 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]
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
18,547 posts in 3,941 threads, 1,192 registered users;
online 23 (1 registered, 22 guests [including 12 identified bots]).

If there is an exception to any rule,
and if it can be proved by observation,
that rule is wrong.    Richard Feynman

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed