FDA Guidance for Industry Part 11, Electronic Records; Electronic Signatures – free PDF download

Manostaxx
Manostaxx

 

http://www.manostaxx.com

 

 

Under the narrow interpretation of the scope of part 11, with respect to records required to be maintained under predicate rules or submitted to FDA, when persons choose to use records in electronic format in place of paper format, part 11 would apply. On the other hand, when persons use computers to generate paper printouts of electronic records, and those paper records meet all the requirements of the applicable predicate rules and persons rely on the paper records to perform their regulated activities, FDA would generally not consider persons to be “using  electronic records in lieu of paper records” under §§ 11.2(a) and 11.2(b). In these instances, the  use of computer systems in the generation of paper records would not trigger part 11.

 

Download PDF here

 

Continue at: https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm125125.pdf

The text above is owned by the site above referred.

Here is only a small part of the article, for more please follow the link

Also see:

https://dadoswebaxx.weebly.com/

 

DadosWebaxx
DadosWebAxx

Leave a Reply

Your email address will not be published. Required fields are marked *