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raghavendra_s ★ 2010-06-21 12:02 (5047 d 19:40 ago) Posting: # 5545 Views: 6,771 |
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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, |
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Ohlbe ★★★ France, 2010-06-21 12:24 (5047 d 19:18 ago) @ raghavendra_s Posting: # 5546 Views: 5,687 |
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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 |
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tempa ☆ India, 2017-08-02 04:32 (2449 d 03:10 ago) @ raghavendra_s Posting: # 17645 Views: 3,481 |
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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] |
Ing. Helmut Schütz