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This thread is carried over and continued in the Current Elsmar Cove Forums |
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This thread is carried over and continued in the Current Elsmar Cove Forums |
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 The Old Elsmar Cove Forums
 FDA and Medical Devices
 Electronic Records and Signatures
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| Author | Topic: Electronic Records and Signatures |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 05 April 2001 10:18 AM
   
The pharmaceutical industry is moving towards the electronic records/electronic signatures and the FDA has issued regulations regarding electronic records/signatures (21 CFR Part 11). You may review the regulation by visiting the FDA web site, www.fda.gov/ora/compliance_ref/part11/ [This message has been edited by Marc Smith (edited 05 April 2001).] IP: Logged |
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Al Weisenborn Lurker (<10 Posts) Posts: 4 |
posted 08 May 2001 10:05 AM
If Part 11 is on your mind, you may find ERESHelp to be a useful reference tool. It is available for free at http://www.qsrhelp.com/products.shtml. ERESHelp provides instant access to 21 CFR Part 11, Electronic Records; Electronic signatures and the FDA comments regarding the regulation. Key Features * Search the by topic * Search the by word or phrase * Browse topics * Personal annotation of topics * Fully indexed * Bookmarking ERESHelp also provides hypertext links so that you may move instantly from the table of contents to a specific section of the document. Part 11 has specific definitions for 9 terms. You may instantly check these definitions by clicking on words or phrases that have a dotted underscore. ------------------
[This message has been edited by Al Weisenborn (edited 08 May 2001).] IP: Logged |
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