1.0Smart Food Safehttps://smartfoodsafe.com/cloneManu Rhttps://smartfoodsafe.com/clone/author/manu/rich600338<blockquote class="wp-embedded-content" data-secret="VouxkyXHpn"><a href="https://smartfoodsafe.com/clone/fda-21-cfr-part-11/">Simplifying FDA 21 CFR Part 11 for Regulatory Records and Documentation in Electronic Systems: Effortless Compliance with Smart Food Safe</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://smartfoodsafe.com/clone/fda-21-cfr-part-11/embed/#?secret=VouxkyXHpn" width="600" height="338" title="“Simplifying FDA 21 CFR Part 11 for Regulatory Records and Documentation in Electronic Systems: Effortless Compliance with Smart Food Safe” — Smart Food Safe" data-secret="VouxkyXHpn" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script type="text/javascript"> /* <![CDATA[ */ /*! This file is auto-generated */ !function(d,l){"use strict";l.querySelector&&d.addEventListener&&"undefined"!=typeof URL&&(d.wp=d.wp||{},d.wp.receiveEmbedMessage||(d.wp.receiveEmbedMessage=function(e){var t=e.data;if((t||t.secret||t.message||t.value)&&!/[^a-zA-Z0-9]/.test(t.secret)){for(var s,r,n,a=l.querySelectorAll('iframe[data-secret="'+t.secret+'"]'),o=l.querySelectorAll('blockquote[data-secret="'+t.secret+'"]'),c=new RegExp("^https?:$","i"),i=0;i<o.length;i++)o[i].style.display="none";for(i=0;i<a.length;i++)s=a[i],e.source===s.contentWindow&&(s.removeAttribute("style"),"height"===t.message?(1e3<(r=parseInt(t.value,10))?r=1e3:~~r<200&&(r=200),s.height=r):"link"===t.message&&(r=new URL(s.getAttribute("src")),n=new URL(t.value),c.test(n.protocol))&&n.host===r.host&&l.activeElement===s&&(d.top.location.href=t.value))}},d.addEventListener("message",d.wp.receiveEmbedMessage,!1),l.addEventListener("DOMContentLoaded",function(){for(var e,t,s=l.querySelectorAll("iframe.wp-embedded-content"),r=0;r<s.length;r++)(t=(e=s[r]).getAttribute("data-secret"))||(t=Math.random().toString(36).substring(2,12),e.src+="#?secret="+t,e.setAttribute("data-secret",t)),e.contentWindow.postMessage({message:"ready",secret:t},"*")},!1)))}(window,document); //# sourceURL=https://smartfoodsafe.com/clone/wp-includes/js/wp-embed.min.js /* ]]> */ </script> https://smartfoodsafe.com/clone/wp-content/uploads/2024/09/fda-21-cfr-part-11.png56413601If you are an FDA-regulated industry, you must be familiar with one of the FDA’s key premises for operations; if you didn’t document it, you didn’t do it. This notion exemplifies the significance of maintaining compliant documentation based on the established FDA predicate rules. A vital requirement in this context is the 21 CFR Part 11 regulation. It is a section of the Code of Federal Regulations (CFR) issued by the FDA outlining the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.