http://www.askaboutvalidation.com/21-cfr-part-11-system-access-to-authorized-individuals/ The World's No.1 Validation Forum Wed, 15 May 2013 21:48:02 +0000 hourly 1 http://wordpress.org/?v=3.5.1 http://www.askaboutvalidation.com/21-cfr-part-11-system-access-to-authorized-individuals/#comment-346 gokeeffe Wed, 25 Apr 2012 20:38:13 +0000 http://www.askaboutvalidation.com/?p=47706#comment-346 Hello kaysee12, thank you for pointing out this error we have now updated the article.

]]> http://www.askaboutvalidation.com/21-cfr-part-11-system-access-to-authorized-individuals/#comment-702 gokeeffe Wed, 25 Apr 2012 20:38:13 +0000 http://www.askaboutvalidation.com/?p=47706#comment-702 Hello kaysee12, thank you for pointing out this error we have now updated the article.

]]> http://www.askaboutvalidation.com/21-cfr-part-11-system-access-to-authorized-individuals/#comment-345 kaysee12 Wed, 25 Apr 2012 20:27:47 +0000 http://www.askaboutvalidation.com/?p=47706#comment-345 I am very disappointed with this article. You have quoted section 11.200 of Part 11, “Electronic signature components and controls”, but the rest of your article discusses system access and data protection. While many companies do use the same components to control user access as they use for electronic signatures, the user id/password combination and electronic signature components serve very different purposes. They should never be thought of as the same thing; this can lead to confusion about the use, meaning, and application of electronic signatures, and improper implementation of controls required by Part 11.
The recommended access controls discussed in this article, and the regulatory action cited do not appear to be related to electronic signatures. The applicable sections of part 11 are 11.10 “Controls for closed systems” and 11.30 “Controls for open systems.”
Access controls serve the purpose of helping to protect data integrity. Electronic signatures are intended to take the place of handwritten signatures on paper.
There is enough misinterpretation and misunderstanding of the regulations out there without having it perpetuated in this forum.

]]> http://www.askaboutvalidation.com/21-cfr-part-11-system-access-to-authorized-individuals/#comment-701 kaysee12 Wed, 25 Apr 2012 20:27:47 +0000 http://www.askaboutvalidation.com/?p=47706#comment-701 I am very disappointed with this article. You have quoted section 11.200 of Part 11, “Electronic signature components and controls”, but the rest of your article discusses system access and data protection. While many companies do use the same components to control user access as they use for electronic signatures, the user id/password combination and electronic signature components serve very different purposes. They should never be thought of as the same thing; this can lead to confusion about the use, meaning, and application of electronic signatures, and improper implementation of controls required by Part 11.
The recommended access controls discussed in this article, and the regulatory action cited do not appear to be related to electronic signatures. The applicable sections of part 11 are 11.10 “Controls for closed systems” and 11.30 “Controls for open systems.”
Access controls serve the purpose of helping to protect data integrity. Electronic signatures are intended to take the place of handwritten signatures on paper.
There is enough misinterpretation and misunderstanding of the regulations out there without having it perpetuated in this forum.

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