{"id":44019,"date":"2022-11-22T15:44:14","date_gmt":"2022-11-22T08:44:14","guid":{"rendered":"https:\/\/techmaster.com.vn\/?page_id=44019"},"modified":"2022-11-22T15:45:42","modified_gmt":"2022-11-22T08:45:42","slug":"data-integrity-and-21-cfr-part-11","status":"publish","type":"page","link":"https:\/\/techmaster.com.vn\/en\/data-integrity-and-21-cfr-part-11\/","title":{"rendered":"Data Integrity and 21 CFR Part 11"},"content":{"rendered":"\n\t<section class=\"section\" id=\"section_1711692647\">\n\t\t<div class=\"bg section-bg fill bg-fill  \" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n\n<div class=\"row\"  id=\"row-224051481\">\n\n\n\t<div id=\"col-35058914\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<div id=\"text-3779511249\" class=\"text\">\n\t\t\n\n<h2 class=\"banner-title\" style=\"text-align: left;\">21 CFR Part 11 and Data Management for Data Integrity<\/h2>\n\t\t\n<style>\n#text-3779511249 {\n  font-size: 1.6rem;\n  line-height: 1.2;\n  color: rgb(255,255,255);\n}\n#text-3779511249 > * {\n  color: rgb(255,255,255);\n}\n<\/style>\n\t<\/div>\n\t\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-35058914 > .col-inner {\n  padding: 0px 0px 0px 40px;\n  margin: -12px 0px -55px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1711692647 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n#section_1711692647 .section-bg.bg-loaded {\n  background-image: url(https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/07\/banner-knowledge.jpeg);\n}\n#section_1711692647 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_1711692647 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n\t<\/section>\n\t\n\t<section class=\"section\" id=\"section_1769270506\">\n\t\t<div class=\"bg section-bg fill bg-fill  bg-loaded\" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n\n<div class=\"row\"  id=\"row-1007663639\">\n\n\n\t<div id=\"col-939590274\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<h2><span data-text-color=\"alert\">Paper: Understand &amp; Comply with GMP &amp; FDA Data Integrity Requirements<\/span><\/h2>\n<p>This data integrity paper, \u201cUnderstanding and Becoming Compliant with GMP and FDA Requirements\u201d, discusses data\u00a0 (such as environmental monitoring data or data from personnel) requirements and management. After reading this paper you will better understand 21 CFR Part 11 data requirements including data management and electronic signatures.<\/p>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1578233272\" class=\"col medium-2 small-12 large-2\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-105400374\" class=\"col medium-8 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_1239828263\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"695\" height=\"175\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/alcoa.png\" class=\"attachment-large size-large\" alt=\"alcoa\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_1239828263 {\n  width: 90%;\n}\n<\/style>\n\t<\/div>\n\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1106801405\" class=\"col medium-2 small-12 large-2\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-869830867\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<p>Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which in turn ensures the product\u2019s quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept. The importance of record-keeping in drug manufacturing can be seen as far back as 1938, when the Federal Food, Drug, and Cosmetic (FDC) Act required the safety of new drugs be documented before being sold to the public, with similar regulations instigated in Europe and Japan throughout the 20th century.<br \/>.<br \/>Production systems have large, inherent operational risks and are difficult to validate. Instead of only being reactive to public health disasters, preventative measures, such as the requirement for proof of claims, are taken to lower their likelihood and propagate confidence in manufacturers.<\/p>\n<p>Read this paper to learn about 21 CFR Part 11 data integrity requirements. The document is divided into three parts:<\/p>\n<ol>\n<li>General Provisions<\/li>\n<li>Electronic Records<\/li>\n<li>Electronic Signatures<\/li>\n<\/ol>\n<p style=\"text-align: center;\"><strong>Complete the form to get the full paper.<\/strong><\/p>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-614766966\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-652653487\" class=\"col medium-3 small-12 large-3\"  >\n\t\t\t\t<div class=\"col-inner text-center\"  >\n\t\t\t\n\t\t\t\n\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_1246574311\">\n\t\t<a class=\"\" href=\"https:\/\/techmaster.com.vn\/en\/contact\/#request\"  >\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"200\" height=\"40\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/email-buttons-GET-A-QUOTE-small.png\" class=\"attachment-large size-large\" alt=\"buttons GET A QUOTE\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/a>\t\t\n<style>\n#image_1246574311 {\n  width: 75%;\n}\n<\/style>\n\t<\/div>\n\t\n\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-652653487 > .col-inner {\n  margin: -30px 0px 0px 40px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1832151711\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1769270506 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n#section_1769270506 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_1769270506 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n\t<\/section>\n\t\n\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":11,"featured_media":44031,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"footnotes":""},"class_list":["post-44019","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - 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