{"id":509754,"date":"2024-11-05T14:08:24","date_gmt":"2024-11-05T14:08:24","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/cga-m-16-2016\/"},"modified":"2024-11-05T14:08:24","modified_gmt":"2024-11-05T14:08:24","slug":"cga-m-16-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/cga\/cga-m-16-2016\/","title":{"rendered":"CGA M-16-2016"},"content":{"rendered":"<p>This guideline is based upon FDA&#039;s August 2003 Guidance for Industry Part 11, Electronic Records; Electronic Signatures\u2014Scope and Application and satisfies the criteria of 21 CFR Part 11, \u00a7 11.1 (a) &#034;The regulations in this part set forth the criteria under which the agency considers e-records, e-signatures, and handwritten signatures executed to e-records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper&#034;. <\/p>\n<p> This guideline also harmonizes with PIC\/S Guide for good manufacturing practice for medicinal products, Annex 11 &#034;Computerised Systems&#034; (as adopted in Canada).<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Guidance for Electronic Records and Signatures in the U.S. and Canadian Food, Drug, and Medical Device Gas and Gas Equipment Industry<\/b><\/p>\n<table style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/cga\/\"><b>CGA<\/b><\/a><\/td>\n<td>2016-03-01<\/td>\n<td>16<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":509765,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2662],"product_tag":[],"class_list":{"0":"post-509754","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-cga","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/509754","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/509765"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=509754"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=509754"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=509754"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}