{"id":1390,"date":"2017-06-24T18:26:04","date_gmt":"2017-06-24T22:26:04","guid":{"rendered":"https:\/\/3sixtypharma.com\/?p=1390"},"modified":"2018-01-13T14:14:35","modified_gmt":"2018-01-13T19:14:35","slug":"fda-issues-qa-draft-guidance-use-of-electronic-records-and-electronic-signatures-in-clinical-investigations","status":"publish","type":"post","link":"https:\/\/3sixtypharma.com\/2017\/06\/24\/fda-issues-qa-draft-guidance-use-of-electronic-records-and-electronic-signatures-in-clinical-investigations\/","title":{"rendered":"FDA Issues Q&A Draft Guidance: Use of Electronic Records and Electronic Signatures in Clinical Investigations"},"content":{"rendered":"

On June 20, 2017, FDA issued the document Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 \u2013 Questions and Answers Guidance for Industry DRAFT GUIDANCE.<\/em><\/strong><\/span><\/p>\n

The goals of this guidance are as follows:<\/span><\/p>\n

\u2022 Update recommendations for applying and implementing part 11 requirements in the current environment of electronic systems used in clinical investigations<\/span><\/p>\n

\u2022 Clarify and further expand on the risk-based approach described in the 2003 part 11 guidance to validation, audit trails, and archiving of records<\/span><\/p>\n

\u2022 Encourage and facilitate the use of electronic records and systems to improve the quality and efficiency of clinical investigations<\/span><\/p>\n

Click here <\/span><\/a><\/span>to view the document.<\/span><\/p>\n

 <\/p>\n

 <\/p>\n

\"\"<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

On June 20, 2017, FDA issued the document Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 \u2013 Questions and Answers Guidance for Industry DRAFT GUIDANCE. The goals of this guidance are as follows: \u2022 Update recommendations for applying and implementing part 11 requirements in the current environment of[…]<\/a><\/p>\n","protected":false},"author":2,"featured_media":621,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","enabled":false}}},"categories":[8],"tags":[],"class_list":["post-1390","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-news"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/3sixtypharma.com\/wp-content\/uploads\/2016\/06\/FDA-Logo.png?fit=644%2C397&ssl=1","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p7wLmz-mq","jetpack_likes_enabled":true,"jetpack-related-posts":[],"_links":{"self":[{"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/posts\/1390"}],"collection":[{"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/comments?post=1390"}],"version-history":[{"count":0,"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/posts\/1390\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/media\/621"}],"wp:attachment":[{"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/media?parent=1390"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/categories?post=1390"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/3sixtypharma.com\/wp-json\/wp\/v2\/tags?post=1390"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}