{"id":2879,"date":"2016-02-15T22:00:00","date_gmt":"2016-02-15T22:00:00","guid":{"rendered":"https:\/\/mpulse.cloud.fruitionqa.com\/cmms-software-21-cfr-11-compliance-what-you-need-to-know\/"},"modified":"2025-07-30T06:29:45","modified_gmt":"2025-07-30T06:29:45","slug":"cmms-software-21-cfr-11-compliance","status":"publish","type":"post","link":"https:\/\/mpulsesoftware.com\/blog\/cmms\/cmms-software-21-cfr-11-compliance\/","title":{"rendered":"CMMS Software and 21 CFR 11 Compliance, Part 1: What You Need to Know"},"content":{"rendered":"<p>Today I got a phone call from an MPulse customer, Eric, who is a maintenance manager at a biotech company. He\u2019s planning a maintenance software upgrade, and he had a good question:<\/p>\n<p>\u201cSteve, I\u2019ve got a coworker telling me our CMMS solution needs to be 21 CFR 11 compliant. Is MPulse Software certified for 21 CFR 11?\u201d<\/p>\n<p>That\u2019s a great question, but the answer isn\u2019t simply \u201cYes\u201d or \u201cNo.\u201d<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_81 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/mpulsesoftware.com\/blog\/cmms\/cmms-software-21-cfr-11-compliance\/#What_is_Title_21_CFR_Part_11\" >What is Title 21 CFR, Part 11?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/mpulsesoftware.com\/blog\/cmms\/cmms-software-21-cfr-11-compliance\/#Can_CMMS_Software_Be_21_CFR_11_Certified\" >Can CMMS Software Be 21 CFR 11 Certified?<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"What_is_Title_21_CFR_Part_11\"><\/span>What is Title 21 CFR, Part 11?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>If you work in the pharmaceutical, medical device, biotech, or related industry, Title 21 CFR Part 11 is a major part of your operations.<\/p>\n<p>The name refers to the part of Title 21 of the Code of Federal Regulations that establishes the U.S. Food and Drug Administration (FDA) regulations on electronic records and electronic signatures\u2014defining the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.<\/p>\n<p>Naturally, 21 CFR 11 compliance is closely tied to software. And in the maintenance department, that software is\u2014of course\u2014CMMS software.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Can_CMMS_Software_Be_21_CFR_11_Certified\"><\/span>Can CMMS Software Be 21 CFR 11 Certified?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Eric\u2019s question, however, relates to a common misconception about software and compliance. To be Title 21 CFR 11 compliant, Eric\u2019s organization must show it has\u2026<\/p>\n<ol>\n<li>Procedural controls<\/li>\n<li>Administrative controls<\/li>\n<li>Technical controls.<\/li>\n<\/ol>\n<p>Now a software vendor can provide the technical elements of a 21 CFR 11 compliant system, which MPulse Software factors\u2014procedural and administrative controls\u2014relate to the organization\u2019s <em>process<\/em>, not the tool.<\/p>\n<p>So the answer to Eric\u2019s question is MPulse Software provides the technical elements of a compliant system. However, we do not claim compliance as the bulk of compliance is related to the <em>use<\/em> of the tools, not the tools themselves.<\/p>\n<p>As such, there is no recognized certification process for software developers. Just like you cannot buy a 21 CFR 11 compliant socket wrench, you cannot buy 21 CFR 11 compliant software.<\/p>\n<p>It\u2019s an important distinction that is sometimes not fully understood.<\/p>\n<p>However, CMMS software is the best tool for maintenance departments to achieve the technical controls for 21 CFR 11 compliance as well as other regulatory certifications like ISO or HIPAA or Sarbanes-Oxley. Learn more about the tools you need for <a href=\"https:\/\/mpulsesoftware.com\/blog\/cmms\/cmms-software-21-cfr-11-compliance-part-2\/\">CMMS and CFR 11 compliance<\/a>. Or <a href=\"https:\/\/mpulsesoftware.com\/contact\/\">contact MPulse<\/a> with questions. We have the answers you need.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Today I got a phone call from an MPulse customer, Eric, who is a maintenance manager at a biotech company. He\u2019s planning a maintenance software upgrade, and he had a good question: \u201cSteve, I\u2019ve got a coworker telling me our CMMS solution needs to be 21 CFR 11 compliant. Is MPulse Software certified for 21 CFR 11?\u201d That\u2019s a great question, but the answer isn\u2019t simply \u201cYes\u201d or \u201cNo.\u201d What is Title 21 CFR, Part 11? If you work in the pharmaceutical, medical device, biotech, or related industry, Title 21 CFR Part 11 is a major part of your operations. The name refers to the part of Title 21 of the Code of Federal Regulations that establishes the U.S. Food and Drug Administration (FDA) regulations on electronic records and electronic signatures\u2014defining the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Naturally, 21 CFR 11 compliance is closely tied to software. And in the maintenance department, that software is\u2014of course\u2014CMMS software. Can CMMS Software Be 21 CFR 11 Certified? Eric\u2019s question, however, relates to a common misconception about software and compliance. To be Title 21 CFR 11 compliant, Eric\u2019s organization must show it has\u2026 Procedural controls Administrative controls Technical controls. Now a software vendor can provide the technical elements of a 21 CFR 11 compliant system, which MPulse Software factors\u2014procedural and administrative controls\u2014relate to the organization\u2019s process, not the tool. So the answer to Eric\u2019s question is MPulse Software provides the technical elements of a compliant system. However, we do not claim compliance as the bulk of compliance is related to the use of the tools, not the tools themselves. As such, there is no recognized certification process for software developers. Just like you cannot buy a 21 CFR 11 compliant socket wrench, you cannot buy 21 CFR 11 compliant software. It\u2019s an important distinction that is sometimes not fully understood. However, CMMS software is the best tool for maintenance departments to achieve the technical controls for 21 CFR 11 compliance as well as other regulatory certifications like ISO or HIPAA or Sarbanes-Oxley. Learn more about the tools you need for CMMS and CFR 11 compliance. Or contact MPulse with questions. We have the answers you need.<\/p>\n","protected":false},"author":6,"featured_media":2880,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","footnotes":""},"categories":[12],"tags":[],"class_list":["post-2879","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmms"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>CMMS and 21 CFR 11 Compliance: What to Know<\/title>\n<meta name=\"description\" content=\"Learn about CMMS software and 21 CFR 11 compliance. Find out if CMMS can support operations in the pharmaceutical and biotech industries.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mpulsesoftware.com\/blog\/cmms\/cmms-software-21-cfr-11-compliance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CMMS Software and 21 CFR 11 Compliance, Part 1: What You Need to Know\" \/>\n<meta property=\"og:description\" content=\"Learn about CMMS software and 21 CFR 11 compliance. 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