raghavendra_s ★ 2010-06-21 12:02 (5054 d 22:37 ago) Posting: # 5545 Views: 6,826 |
|
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 ★★★ France, 2010-06-21 12:24 (5054 d 22:15 ago) @ raghavendra_s Posting: # 5546 Views: 5,729 |
|
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 ☆ India, 2017-08-02 04:32 (2456 d 06:07 ago) @ raghavendra_s Posting: # 17645 Views: 3,522 |
|
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] |