{"id":2877,"date":"2021-04-19T00:00:00","date_gmt":"2021-04-19T00:00:00","guid":{"rendered":"https:\/\/mpulse.cloud.fruitionqa.com\/cmms-software-21-cfr-11-compliance-part-2-tools-you-need\/"},"modified":"2025-07-30T06:18:13","modified_gmt":"2025-07-30T06:18:13","slug":"cmms-21-cfr-11-compliance-2","status":"publish","type":"post","link":"https:\/\/mpulsesoftware.com\/blog\/cmms\/cmms-21-cfr-11-compliance-2\/","title":{"rendered":"CMMS Software and 21 CFR 11 Compliance, Part 2: The Tools You Need"},"content":{"rendered":"<p>My <a href=\"https:\/\/www.mpulsesoftware.com\/CMMS-software-21-CFR-11-compliance-what-you-need-to-know\">last post<\/a> detailed CMMS software\u2019s role in Title 21 CFR Part 11 compliance certification. In this blog, I\u2019ll discuss why CMMS software is a great tool for companies looking to achieve 21 CFR 11 compliance certification, as well as other regulatory certifications like ISO, HIPAA, Sarbanes-Oxley, etc.<\/p>\n<p>If you recall, our friend Eric, a maintenance manager at a biotech company, was researching a maintenance software upgrade when his coworker brought up 21 CFR 11 compliance\u2014a U.S. Food and Drug Administration (FDA) standard detailing how the agency will accept electronic records and electronic signatures as the equivalent to corresponding paper records.<\/p>\n<p>We learned about the three Title 21 CFR Part 11 compliance requirements (procedural, administrative, and technical controls) as well as the capability of CMMS software as a powerful tool for the technical controls of a compliant system.<\/p>\n<p>But what are those technical controls, and how does MPulse CMMS software support them?<\/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-21-cfr-11-compliance-2\/#How_Does_CMMS_Software_Help_with_Title_21_CFR_11_Compliance\" >How Does CMMS Software Help with Title 21 CFR 11 Compliance?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/mpulsesoftware.com\/blog\/cmms\/cmms-21-cfr-11-compliance-2\/#Its_All_About_the_Data\" >It\u2019s All About the Data<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"How_Does_CMMS_Software_Help_with_Title_21_CFR_11_Compliance\"><\/span>How Does CMMS Software Help with Title 21 CFR 11 Compliance?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>CMMS software excels at tracking the details of your increasingly complex maintenance operation. Because for regulatory agencies, if it\u2019s not documented, it didn\u2019t happen.<\/p>\n<p>MPulse Software, Inc helps promote and maintain CMMS compliance with the features your maintenance team needs, including\u2026<\/p>\n<ul>\n<li>User-defined permissions, access, and login control that can integrate with your active directory<\/li>\n<li>Electronic signature support with limited access to a specific signature field to enter approval<\/li>\n<li>Preventive maintenance scheduling and documentation<\/li>\n<li>Corrective maintenance tracking and documentation<\/li>\n<li>Robust compliance reporting capabilities<\/li>\n<li>Automated data collection and archived work history<\/li>\n<li>Documentation of processes and procedures<\/li>\n<li>Hosting capability for third-party software that creates audit trails.<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Its_All_About_the_Data\"><\/span>It\u2019s All About the Data<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>CMMS software provides a reliable central repository for your maintenance and safety data. That\u2019s why CMMS software is the right solution to help companies in the pharmaceutical, medical device, biotech, or <a href=\"https:\/\/mpulsesoftware.com\/blog\/cmms\/cmms-software-in-healthcare\/\">related industries<\/a> cope with complex requirements like 21 CFR 11.<\/p>\n<p>With MPulse Software, Inc, you&#8217;ll have a traceable history of completed maintenance tasks and documented policies to prove to the FDA that you\u2019re acting in accordance with 21 CFR 11 requirements. And the best thing is, once you get your MPulse CMMS software set up correctly, the documentation takes care of itself, so you can focus on other important things\u2014like maintenance.<\/p>\n<p>Learn more about how MPulse&#8217;s <a href=\"https:\/\/mpulsesoftware.com\/software\/features\/media-management\/\">CMMS Media Management Feature<\/a> can assist you with all your documents and files.<\/p>\n<p>We\u2019re all in this together. What\u2019s your experience with 21 CFR 11 compliance in the maintenance field? Leave a comment or <a href=\"https:\/\/mpulsesoftware.com\/Contact\/\">contact me<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>My last post detailed CMMS software\u2019s role in Title 21 CFR Part 11 compliance certification. In this blog, I\u2019ll discuss why CMMS software is a great tool for companies looking to achieve 21 CFR 11 compliance certification, as well as other regulatory certifications like ISO, HIPAA, Sarbanes-Oxley, etc. If you recall, our friend Eric, a maintenance manager at a biotech company, was researching a maintenance software upgrade when his coworker brought up 21 CFR 11 compliance\u2014a U.S. Food and Drug Administration (FDA) standard detailing how the agency will accept electronic records and electronic signatures as the equivalent to corresponding paper records. We learned about the three Title 21 CFR Part 11 compliance requirements (procedural, administrative, and technical controls) as well as the capability of CMMS software as a powerful tool for the technical controls of a compliant system. But what are those technical controls, and how does MPulse CMMS software support them? How Does CMMS Software Help with Title 21 CFR 11 Compliance? CMMS software excels at tracking the details of your increasingly complex maintenance operation. Because for regulatory agencies, if it\u2019s not documented, it didn\u2019t happen. MPulse Software, Inc helps promote and maintain CMMS compliance with the features your maintenance team needs, including\u2026 User-defined permissions, access, and login control that can integrate with your active directory Electronic signature support with limited access to a specific signature field to enter approval Preventive maintenance scheduling and documentation Corrective maintenance tracking and documentation Robust compliance reporting capabilities Automated data collection and archived work history Documentation of processes and procedures Hosting capability for third-party software that creates audit trails. It\u2019s All About the Data CMMS software provides a reliable central repository for your maintenance and safety data. That\u2019s why CMMS software is the right solution to help companies in the pharmaceutical, medical device, biotech, or related industries cope with complex requirements like 21 CFR 11. With MPulse Software, Inc, you&#8217;ll have a traceable history of completed maintenance tasks and documented policies to prove to the FDA that you\u2019re acting in accordance with 21 CFR 11 requirements. And the best thing is, once you get your MPulse CMMS software set up correctly, the documentation takes care of itself, so you can focus on other important things\u2014like maintenance. Learn more about how MPulse&#8217;s CMMS Media Management Feature can assist you with all your documents and files. We\u2019re all in this together. What\u2019s your experience with 21 CFR 11 compliance in the maintenance field? Leave a comment or contact me.<\/p>\n","protected":false},"author":6,"featured_media":2878,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","footnotes":""},"categories":[12],"tags":[],"class_list":["post-2877","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>Tools You Need To Be 21 CFR 11 Compliant | MPulse Software<\/title>\n<meta name=\"description\" content=\"MPulse&#039;s CMMS Software has the tools to assist with Title 21 CFR 11 compliance requirements. Learn more about the benefits of our CMMS software features.\" \/>\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-21-cfr-11-compliance-2\/\" \/>\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 2: The Tools You Need\" \/>\n<meta property=\"og:description\" content=\"MPulse&#039;s CMMS Software has the tools to assist with Title 21 CFR 11 compliance requirements. 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