{"id":14338,"date":"2023-09-14T13:21:07","date_gmt":"2023-09-14T19:21:07","guid":{"rendered":"https:\/\/limblecmms.com\/?page_id=14338"},"modified":"2025-06-30T07:55:09","modified_gmt":"2025-06-30T13:55:09","slug":"21-cfr","status":"publish","type":"page","link":"https:\/\/limblecmms.com\/learn\/definitions\/21-cfr\/","title":{"rendered":"21 CFR"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row full_width=&#8221;stretch_row&#8221; kd_background_image_position=&#8221;vc_row-bg-position-top&#8221; css=&#8221;.vc_custom_1734562083174{background: #001939 url(https:\/\/limblecmms.com\/wp-content\/uploads\/blog-header-hex-bg4.webp?id=9266) !important;background-position: 0 0 !important;background-repeat: no-repeat !important;}&#8221;][vc_column css=&#8221;.vc_custom_1683307506642{padding-bottom: 80px !important;}&#8221;]<header class=\"kd-section-title col-lg-8 vc_col-sm-8 text-center  subtitle-below-title    vc_custom_1694718837875\" ><h1 class=\"separator_off\" style=\"color: #ffffff;font-size: 50;\">21 CFR<\/h1><h2 class=\"subtitle\" style=\"color: #ffffff;font-size:15px;\"><span class=\"ez-toc-section\" id=\"Everything_you_ever_needed_to_know_about_Code_of_Federal_Regulation_CFR\"><\/span>Everything you ever needed to know about Code of Federal Regulation (CFR)<span class=\"ez-toc-section-end\"><\/span><\/h2><\/header><a  href=\"https:\/\/limblecmms.com\/resources\/cmms-buyers-guide\/\"  target=\"_self\"  title=\"\"  class=\"tt_button tt_primary_button btn_primary_color  button-center button-action-link   vc_custom_1742844717530\" ><span class=\"prim_text\">Free CMMS Buyer's Guide<\/span><\/a>\n      <div class=\"entry-meta\">\n         <span class=\"published\">\n            <span class=\"far fa-clock\" aria-hidden=\"true\"><\/span>Last updated on June 30, 2025<\/span>\n            <span class=\"author\"><span class=\"far sway-author-meta\" aria-hidden=\"true\"><\/span>\n            <span>bBrinton<\/span>\n         <\/span>\n      <\/div>\n\n   [\/vc_column][\/vc_row][vc_row kd_background_image_position=&#8221;vc_row-bg-position-top&#8221; css=&#8221;.vc_custom_1687442797424{margin-top: 40px !important;}&#8221; el_class=&#8221;limble-page-blog-width&#8221;][vc_column][vc_column_text]<\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_is_21_CFR\"><\/span>What is 21 CFR?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">The term \u201c21 CFR\u201d refers to <\/span><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/cfrsearch.cfm\"><span style=\"font-weight: 400;\">Title 21 of the Code of Federal Regulations (CFR)<\/span><\/a><span style=\"font-weight: 400;\">, a list of operational requirements that an FDA-regulated manufacturing company must comply with to produce and sell products to consumers. You may also hear it referred to as \u201cCFR Title 21.\u201d\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">21 CFR regulations generally apply to manufacturers of medical devices, pharmaceuticals, or nutraceuticals. These companies produce healthcare and wellness products such as insulin pumps, medications like ibuprofen, or nutritional supplements like vitamins.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">When regulating manufacturing operations, the <\/span><a href=\"https:\/\/www.fda.gov\/\"><span style=\"font-weight: 400;\">Food and Drug Administration (FDA)<\/span><\/a><span style=\"font-weight: 400;\"> cares about two things:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Safety: <\/b><span style=\"font-weight: 400;\">Is your product safe, or is it dangerous to consumers?<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Efficacy<\/b>: Does your product do what it claims to do?<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Note: The FDA regulates companies that sell products to the United States market. However, the regulatory requirements for other countries\/regions, such as Canada or the European Union, are often satisfied when a company complies with 21 CFR.<\/span>[\/vc_column_text][\/vc_column][\/vc_row][vc_row kd_background_image_position=&#8221;vc_row-bg-position-top&#8221; css=&#8221;.vc_custom_1687442797424{margin-top: 40px !important;}&#8221; el_class=&#8221;limble-page-blog-width&#8221;][vc_column][vc_column_text css=&#8221;&#8221;]<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-flat ez-toc-counter ez-toc-custom 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:\/\/limblecmms.com\/learn\/definitions\/21-cfr\/#Everything_you_ever_needed_to_know_about_Code_of_Federal_Regulation_CFR\" >Everything you ever needed to know about Code of Federal Regulation (CFR)<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/limblecmms.com\/learn\/definitions\/21-cfr\/#What_is_21_CFR\" >What is 21 CFR?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/limblecmms.com\/learn\/definitions\/21-cfr\/#How_is_maintenance_related_to_21_CFR\" >How is maintenance related to 21 CFR?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/limblecmms.com\/learn\/definitions\/21-cfr\/#Why_do_you_need_to_care_about_21_CFR_in_maintenance\" >Why do you need to care about 21 CFR in maintenance?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/limblecmms.com\/learn\/definitions\/21-cfr\/#What_to_expect_in_a_21_CFR_audit\" >What to expect in a 21 CFR audit<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/limblecmms.com\/learn\/definitions\/21-cfr\/#How_to_have_perfect_21_CFR_audit_results\" >How to have perfect 21 CFR audit results<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/limblecmms.com\/learn\/definitions\/21-cfr\/#How_proper_documentation_solves_your_21_CFR_problems\" >How proper documentation solves your 21 CFR problems<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/limblecmms.com\/learn\/definitions\/21-cfr\/#What_is_software_validation\" >What is software validation?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/limblecmms.com\/learn\/definitions\/21-cfr\/#How_to_validate_a_CMMS\" >How to validate a CMMS<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/limblecmms.com\/learn\/definitions\/21-cfr\/#Finding_the_right_CMMS\" >Finding the right CMMS<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/limblecmms.com\/learn\/definitions\/21-cfr\/#Pass_your_21_CFR_audit_with_Limble\" >Pass your 21 CFR audit with Limble<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/limblecmms.com\/learn\/definitions\/21-cfr\/#21_CFR_is_easy_with_the_right_tools\" >21 CFR is easy with the right tools<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/limblecmms.com\/learn\/definitions\/21-cfr\/#Related_Content\" >Related Content<\/a><\/li><\/ul><\/nav><\/div>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row kd_background_image_position=&#8221;vc_row-bg-position-top&#8221; css=&#8221;.vc_custom_1687440273251{margin-top: 40px !important;}&#8221; el_class=&#8221;limble-page-blog-width&#8221;][vc_column][vc_column_text]<\/p>\n<h2 id=\"process\"><span class=\"ez-toc-section\" id=\"How_is_maintenance_related_to_21_CFR\"><\/span>How is maintenance related to 21 CFR?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Manufacturers use a variety of machines to produce medical devices, drugs, and nutraceuticals. Because those machines have the potential to impact both the <\/span><i><span style=\"font-weight: 400;\">safety<\/span><\/i><span style=\"font-weight: 400;\"> and the <\/span><i><span style=\"font-weight: 400;\">efficacy<\/span><\/i><span style=\"font-weight: 400;\"> of the end product, 21 CFR includes regulations to ensure they are maintained properly and in a manner that reduces the risk of contamination or other irregularities.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For example, if the air filtration system hasn\u2019t been maintained, particulate matter could enter the manufacturing facility and contaminate the end product. Due to the possibility of contamination, the product may be deemed unsafe for use.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">As a maintenance professional, you will not be required to know everything about 21 CFR. However, you must know the regulations for quality systems, computer systems, and electronic records related to 21 CFR.<\/span>[\/vc_column_text][\/vc_column][\/vc_row][vc_row kd_background_image_position=&#8221;vc_row-bg-position-top&#8221; css=&#8221;.vc_custom_1687440273251{margin-top: 40px !important;}&#8221; el_class=&#8221;limble-page-blog-width&#8221;][vc_column][vc_column_text]<\/p>\n<h2 id=\"types\"><span class=\"ez-toc-section\" id=\"Why_do_you_need_to_care_about_21_CFR_in_maintenance\"><\/span>Why do you need to care about 21 CFR in maintenance?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">One word: audits. Audits are one of the tools regulatory agencies like the FDA use to ensure manufacturers follow consistent and effective procedures.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">A 21 CFR audit will thoroughly review your company\u2019s records to ensure that any required policy, practice, or maintenance task is performed.\u00a0 If an auditor cannot find documentation that a particular 21 CFR rule was followed, it will be noted as non-compliance. As a result, it is essential to have a record-keeping system that makes documentation of such practices simple and easy to review in an auditing scenario.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The consequences of non-compliance (as in findings that don\u2019t comply with 21 CFR) may include many unpleasant penalties such as correction orders, additional audits, product recalls, or, in extreme cases, a complete shutdown of company operations.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">You will want to make sure that your company and your team are as prepared as possible to meet the expectations laid out in the 21 CFR regulations.<\/span>[\/vc_column_text][\/vc_column][\/vc_row][vc_row kd_background_image_position=&#8221;vc_row-bg-position-top&#8221; css=&#8221;.vc_custom_1687440273251{margin-top: 40px !important;}&#8221; el_class=&#8221;limble-page-blog-width&#8221;][vc_column][vc_column_text css=&#8221;&#8221;]<\/p>\n<h2 id=\"procedure\"><span class=\"ez-toc-section\" id=\"What_to_expect_in_a_21_CFR_audit\"><\/span>What to expect in a 21 CFR audit<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">21 CFR audits come in many shapes and sizes, depending on your organization. Here are some quick facts about what an audit might look like.<\/span><\/p>\n<h3><span style=\"font-weight: 400;\">Who conducts 21 CFR audits?<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Auditors can come from many sources. They could be from the FDA, from companies you sell to, or from a foreign entity if you sell to another country. They typically have a background related to your organization\u2019s area of focus.\u00a0<\/span><\/p>\n<h3><span style=\"font-weight: 400;\">When do 21 CFR audits happen?<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Some audits are scheduled, while other audits are unannounced. The best way to keep your auditing schedule at a reasonable interval is to ensure successful audits every time. Organizations that have more areas of non-compliance identified in an audit are more likely to experience additional follow-up audits that may be unannounced.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">That said, 21 CFR includes broad requirements for many areas of an organization. When an auditor visits a company for routine audits, they may not focus on every department every time.<\/span><\/p>\n<h3><span style=\"font-weight: 400;\">What do auditors look for?<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">When an auditor visits your maintenance department, they will want to look at the following:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/limblecmms.com\/blog\/maintenance-history-records\/\"><span style=\"font-weight: 400;\">Maintenance histories<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/limblecmms.com\/learn\/preventive-maintenance\/schedule\/\"><span style=\"font-weight: 400;\">Maintenance schedules<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Software validation (if using software for maintenance)<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">An auditor\u2019s job is to look through your documentation to identify weak points in your policies, procedures, and safety practices that could lead to more significant problems. Each instance where a requirement has not been met (or documented) is called a \u201cnonconformity.\u201d These may include:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/limblecmms.com\/learn\/maintenance-operations\/poor-maintenance-cost\/\"><span style=\"font-weight: 400;\">Improper <\/span><span style=\"font-weight: 400;\">equipment maintenance<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Inaccurate or missing records<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Questionable security of your software or documentation<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Software that doesn\u2019t comply with 21 CFR requirements<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Not following your own company\u2019s policies<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Difficulty finding a document or record associated with a piece of equipment<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Or any other 21 CFR rule or internal policy that has not been followed.<\/span>[\/vc_column_text][\/vc_column][\/vc_row][vc_row kd_background_image_position=&#8221;vc_row-bg-position-top&#8221; el_class=&#8221;limble-page-blog-width&#8221;][vc_column][vc_column_text]<\/p>\n<h2 id=\"procedures\"><span class=\"ez-toc-section\" id=\"How_to_have_perfect_21_CFR_audit_results\"><\/span>How to have perfect 21 CFR audit results<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">To avoid nonconformities during your audit, closely follow this section from 21 CFR:<\/span><\/p>\n<p><i><span style=\"font-weight: 400;\">\u201cEach manufacturer shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Maintenance activities, including the date and individual(s) performing the maintenance activities, shall be documented.\u201d <\/span><\/i><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=820.70\"><i><span style=\"font-weight: 400;\">820.70 (g) (1) Maintenance Schedule<\/span><\/i><\/a><\/p>\n<p><span style=\"font-weight: 400;\">From this section, we learn three things:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">You must maintain your equipment.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Your equipment <\/span><a href=\"https:\/\/limblecmms.com\/blog\/maintenance-policy\/\"><span style=\"font-weight: 400;\">maintenance policies<\/span><\/a><span style=\"font-weight: 400;\">, plans, and schedules must be clearly outlined and documented.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Actions taken to adhere to these policies, plans, and schedules must also be documented.<\/span><\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row kd_background_image_position=&#8221;vc_row-bg-position-top&#8221; el_class=&#8221;limble-page-blog-width&#8221;][vc_column][vc_column_text]<\/p>\n<h2 id=\"procedures\"><span class=\"ez-toc-section\" id=\"How_proper_documentation_solves_your_21_CFR_problems\"><\/span>How proper documentation solves your 21 CFR problems<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">You can document your maintenance with pen and paper, but that can be problematic. Even with the best filing systems, it is easy to have issues producing the correct paper documentation during audits. Any organization that has ever had a misplaced file or an illegible date during an audit will tell you so.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The gold standard is to use a software solution to manage and document any activities subject to regulation. For maintenance teams, a <\/span><a href=\"https:\/\/limblecmms.com\/cmms\/\"><span style=\"font-weight: 400;\">Computerized Maintenance Management System (CMMS)<\/span><\/a><span style=\"font-weight: 400;\"> helps you in two ways.<\/span><\/p>\n<h3><b>1. Maintaining compliance during regular operations<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">A CMMS provides numerous tools to help maintenance teams meet the expectations of regulatory agencies and helps ensure team awareness of required policies and procedures.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Automates <\/span><a href=\"https:\/\/limblecmms.com\/blog\/preventive-maintenance-schedule\/\"><span style=\"font-weight: 400;\">maintenance schedules<\/span><\/a><span style=\"font-weight: 400;\"> and task reminders so nothing gets missed<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Simplifies documentation and data integrity<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Provides access to critical policies and <\/span><a href=\"https:\/\/limblecmms.com\/blog\/standard-operating-procedure-sop\/\"><span style=\"font-weight: 400;\">standard operating procedures<\/span><\/a><span style=\"font-weight: 400;\"> from anywhere<\/span><\/li>\n<\/ul>\n<h3><b>2. Demonstrating compliance during an audit<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">A CMMS ensures your records are always audit-ready. Records, timelines, and policies are easy to locate when audit time comes.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Organizes documentation in a way that is always audit-ready<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Enables quick searches for key information and documentation<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Provides one centralized platform for policy review <\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">In <\/span><a href=\"https:\/\/youtu.be\/ONSFV8d8byQ\"><span style=\"font-weight: 400;\">this video<\/span><\/a><span style=\"font-weight: 400;\">, Cory Mince at Spectrum Solutions talks about how their paper-based system was not \u201ccutting the mustard\u201d for what they needed. When they implemented a CMMS it made all the difference for their next audit.<\/span><\/p>\n<p><iframe loading=\"lazy\" title=\"Smash the audit with Limble!\" width=\"640\" height=\"360\" src=\"https:\/\/www.youtube.com\/embed\/ONSFV8d8byQ?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe><\/p>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row kd_background_image_position=&#8221;vc_row-bg-position-top&#8221; el_class=&#8221;limble-page-blog-width&#8221;][vc_column][vc_column_text css=&#8221;&#8221;]<\/p>\n<h2 id=\"validation\"><span class=\"ez-toc-section\" id=\"What_is_software_validation\"><\/span>What is software validation?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">If you <\/span><i><span style=\"font-weight: 400;\">are <\/span><\/i><span style=\"font-weight: 400;\">taking the digital route and documenting your activities in a CMMS or other software, the FDA has requirements for that, too. It is called \u201csoftware validation.\u201d<\/span><\/p>\n<p><i><span style=\"font-weight: 400;\">\u201cWhen computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.\u201d 820.70 (g) (3) (i) Automated Processes<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400;\">The software validation process proves (and documents) that how you use your maintenance software complies with 21 CFR requirements as well as your own established policies related to 21 CFR. <\/span><\/p>\n<h3><span style=\"font-weight: 400;\">Software validation requirements in 21 CFR Part 11<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">21 CFR Part 11 is all about determining exactly who has done what. When using paper to manage maintenance, signatures and signature dates achieve this. However, with software, tasks are attributed to users based on their logins.\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Unique usernames and login information are given to each individual, creating a clear audit trail.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Automatic timestamps record precisely when something happened in the electronic record.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Strong passwords that are reset regularly protect company data.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Electronic signatures are available when necessary.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Whether you use paper or a CMMS, it is important to know who has performed what actions and to prevent unauthorized individuals from accessing or manipulating your data. It is critical not just for compliance but for the general security of your operations.<\/span><\/p>\n<h3><span style=\"font-weight: 400;\">Software validation requirements in 21 CFR Part 820<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">This section requires a quality system to be in place. Good quality systems aim to ensure the products your company produces meet a minimum level of <\/span><i><span style=\"font-weight: 400;\">safety <\/span><\/i><span style=\"font-weight: 400;\">and <\/span><i><span style=\"font-weight: 400;\">efficacy<\/span><\/i><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The most important aspects of Part 820 for maintenance are:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Defined maintenance schedules<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Records that demonstrate maintenance <\/span><a href=\"https:\/\/limblecmms.com\/metrics\/schedule-compliance\/\"><span style=\"font-weight: 400;\">schedule compliance<\/span><\/a><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The best software to meet this standard is one that was built to manage maintenance schedules and document maintenance work while providing a high degree of data security. When looking for a CMMS, this is a critical consideration for organizations subject to 21 CFR.<\/span><\/p>\n<h3><span style=\"font-weight: 400;\">Company requirements<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">In addition to the requirements written into the regulations, auditors will want to see that you are meeting any other requirements laid out in related internal policies and procedures.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For example, if your company included a requirement to wear purple hats every Tuesday in your employee handbook policy, an auditor would expect to see weekly documentation of purple hat day somewhere in your records, even though that particular requirement isn\u2019t dictated by 21 CFR rules.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Building mechanisms and spaces to document each part of your internal processes is critical to any compliance program. <\/span>[\/vc_column_text][\/vc_column][\/vc_row][vc_row kd_background_image_position=&#8221;vc_row-bg-position-top&#8221; el_class=&#8221;limble-page-blog-width&#8221;][vc_column][vc_column_text css=&#8221;&#8221;]<\/p>\n<h2 id=\"cmms\"><span class=\"ez-toc-section\" id=\"How_to_validate_a_CMMS\"><\/span>How to validate a CMMS<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter\" src=\"https:\/\/limblecmms.com\/wp-content\/uploads\/how-to-validate-a-cmms.jpg\" width=\"498\" height=\"166\" \/><br \/>\n<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Software validation requires a company to test the software fully to ensure adherence to the requirements of 21 CFR and any internal policies. To achieve this, organizations have a few different paths to choose from.<\/span><\/p>\n<h3><span style=\"font-weight: 400;\">Path 1: Accept validation from the software provider<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">The most common path is for companies to simply choose software that has already been built to meet 21 CFR regulations. In these cases, the responsibility still lies with the manufacturer to perform final validation based on how the system will be used in their environment. However, the vendor has already done much of their own testing.\u00a0\u00a0<\/span><\/p>\n<p>At Limble, we provide\u00a0<b data-stringify-type=\"bold\">customers on the 21 CFR plan\u00a0<\/b>with our current validation documentation along with validation testing results.<\/p>\n<h3><span style=\"font-weight: 400;\">Path 2: Perform your own validation<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">If you have a quality assurance team, they may have a process in place for performing your own validation, and this path may be the option they prefer. If you or your quality assurance team needs help, contact a regulatory specialist at Limble for guidance.\u00a0<\/span><\/p>\n<h3><span style=\"font-weight: 400;\">Path 3: A combination of both<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">This path combines Path 1 and Path 2 from above, where you accept the validation from the software provider and then perform additional testing required by your own internal quality systems.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Note: No software can come pre-validated. If a software provider says their software is already \u201ccertified\u201d or that you don\u2019t have to do any paperwork, that they do not understand 21 CFR. The FDA puts that responsibility on the company using the software, as stated in 820.70(g)(3)(i): <\/span><i><span style=\"font-weight: 400;\">\u201cthe manufacturer shall validate computer software.\u201d<\/span><\/i><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">How do you know which path is best for your company? It depends on a few factors.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The most important thing to keep in mind is that auditors will make sure you have a documented process in place to make <\/span><i><span style=\"font-weight: 400;\">safety <\/span><\/i><span style=\"font-weight: 400;\">and <\/span><i><span style=\"font-weight: 400;\">efficacy <\/span><\/i><span style=\"font-weight: 400;\">a priority in everything you do. No matter which path you choose, Limble can provide you with document templates that will help you define your needs and properly document your validation process.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Please keep in mind that no CMMS software provider can declare that you are meeting regulations and standards. That\u2019s for the auditor to decide.<\/span><\/p>\n<h2 id=\"tips\"><span class=\"ez-toc-section\" id=\"Finding_the_right_CMMS\"><\/span>Finding the right CMMS<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">With so many options on the market, it can be difficult to find maintenance software that will work best for you and fully meet 21 CFR requirements. Here\u2019s <\/span><span style=\"font-weight: 400;\">what to look for in a CMMS<\/span><span style=\"font-weight: 400;\"> specific to these regulations<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Validation testing has been performed, and the CMMS provider is willing to share the results with you.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Validation testing is performed by the company for each new update or version release of the software.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The validation testing demonstrates that your needs will be met.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The software is easy to use, helping ensure that documentation is completed thoroughly.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The software was created with 21 CFR in mind.<\/span><\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row_content&#8221; content_placement=&#8221;top&#8221; css_animation=&#8221;fadeInDown&#8221; kd_background_image_position=&#8221;vc_row-bg-position-bottom&#8221; css=&#8221;.vc_custom_1691073586371{margin-top: 50px !important;margin-bottom: 20px !important;padding-top: 50px !important;padding-bottom: 50px !important;background-color: #f1f6f8 !important;background-position: 0 0 !important;background-repeat: no-repeat !important;}&#8221;][vc_column css=&#8221;.vc_custom_1691073594574{padding-right: 70px !important;padding-left: 70px !important;}&#8221;]<div class=\"kd-calltoaction\" >\n                <div class=\"container\">\n                  <div class=\"cta-text-container kd-animated fadeIn\" data-animation-delay=\"200\"><div class=\"cta-text\"><h3 >Want to see Limble in action? Get started for free today!<\/h3><\/div>\n                    <\/div>\n                    <div class=\"cta-btncontainer\"><a href=\"\/get-started\/\"  title=\"\" class=\"tt_button tt_primary_button btn_primary_color  button-action-link icon_right kd-animated zoomIn\" data-animation-delay=\"200\">Start Free Trial<span class=\"fas fa-chevron-right iconita\" ><\/span><\/a><\/div>\n                <\/div>\n            <\/div>[\/vc_column][\/vc_row][vc_row kd_background_image_position=&#8221;vc_row-bg-position-top&#8221; el_class=&#8221;limble-page-blog-width&#8221;][vc_column][vc_column_text css=&#8221;&#8221;]<\/p>\n<h2 id=\"last\"><span class=\"ez-toc-section\" id=\"Pass_your_21_CFR_audit_with_Limble\"><\/span>Pass your 21 CFR audit with Limble<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><a href=\"https:\/\/limblecmms.com\/blog\/cmms-implementation-guide\/\"><span style=\"font-weight: 400;\">Implementing a CMMS <\/span><\/a><span style=\"font-weight: 400;\">is no small feat, especially when 21 CFR compliance is added to the mix. Luckily, Limble can help! We understand the stress of preparing for an audit, which is why we\u2019ve built features right into our CMMS that can help.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Electronic signatures:<\/b><span style=\"font-weight: 400;\"> Limble is designed to comply with the digital signature requirements you\u2019ll need to show an auditor.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Full audit log for assets:<\/b><span style=\"font-weight: 400;\"> Limble will log all of the work history on each asset. We\u2019ve even made it searchable so you can easily find who did what, when, and why.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Validation testing:<\/b><span style=\"font-weight: 400;\"> Limble provides documentation of the validation testing we do before each release.\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">With these features combined with other <\/span><a href=\"https:\/\/limblecmms.com\/blog\/benefits-of-cmms-software\/\"><span style=\"font-weight: 400;\">CMMS benefits<\/span><\/a><span style=\"font-weight: 400;\"> and our personalized customer service, Limble will do everything we can to help you pass your 21 CFR audit!<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"21_CFR_is_easy_with_the_right_tools\"><\/span><span style=\"font-weight: 400;\">21 CFR is easy with the right tools<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Figuring out the nuances of 21 CFR and everything it requires can be a headache. Give yourself less to worry about with a CMMS built with 21 CFR in mind \u2014 and built to meet your needs.<\/span><\/p>\n<p><a href=\"https:\/\/limblecmms.com\/demo-request\/\"><span style=\"font-weight: 400;\">Schedule a demo<\/span><\/a><span style=\"font-weight: 400;\">, or <\/span><a href=\"https:\/\/limblecmms.com\/contact-us\/\"><span style=\"font-weight: 400;\">send us an email<\/span><\/a><span style=\"font-weight: 400;\"> to learn more about how Limble can help your team reach your 21 CFR goals.<\/span>[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; kd_background_image_position=&#8221;vc_row-bg-position-top&#8221; css=&#8221;.vc_custom_1541417547006{padding-top: 100px !important;}&#8221;][vc_column css=&#8221;.vc_custom_1515677064675{padding-right: 0px !important;padding-left: 0px !important;}&#8221;][vc_row_inner kd_background_image_position=&#8221;vc_row-bg-position-top&#8221;][vc_column_inner]<header class=\"kd-section-title vc_col-lg-6 vc_col-sm-8 text-center  subtitle-below-title kd-animated fadeIn   vc_custom_1679419307921\" data-animation-delay=200><h2 class=\"separator_off\" ><span class=\"ez-toc-section\" id=\"Related_Content\"><\/span>Related Content<span class=\"ez-toc-section-end\"><\/span><\/h2><h6 class=\"subtitle\" >Explore our blog for insightful articles, personal reflections and ideas that inspire action on the topics you care about.<\/h6><\/header>[\/vc_column_inner][\/vc_row_inner][vc_row_inner kd_background_image_position=&#8221;vc_row-bg-position-top&#8221; css=&#8221;.vc_custom_1541417551563{padding-bottom: 100px !important;}&#8221;][vc_column_inner width=&#8221;1\/3&#8243;]<div class=\"kd-photobox  \" ><a href=\"https:\/\/limblecmms.com\/blog\/maintenance-strategy\/\"  title=\"Read More\"><div class=\"photobox-img\"><img loading=\"lazy\" decoding=\"async\" width=\"700\" height=\"700\" src=\"https:\/\/limblecmms.com\/wp-content\/uploads\/The-Ins-And-Outs-Of-A-Maintenance-Work-Request.jpg\" class=\"attachment-full\" alt=\"Maintenance Work Order Template\" title=\"The-Ins-And-Outs-Of-A-Maintenance-Work-Request\" srcset=\"https:\/\/limblecmms.com\/wp-content\/uploads\/The-Ins-And-Outs-Of-A-Maintenance-Work-Request.jpg 700w, https:\/\/limblecmms.com\/wp-content\/uploads\/The-Ins-And-Outs-Of-A-Maintenance-Work-Request-300x300.jpg 300w, https:\/\/limblecmms.com\/wp-content\/uploads\/The-Ins-And-Outs-Of-A-Maintenance-Work-Request-150x150.jpg 150w, https:\/\/limblecmms.com\/wp-content\/uploads\/The-Ins-And-Outs-Of-A-Maintenance-Work-Request-320x320.jpg 320w\" sizes=\"auto, (max-width: 700px) 100vw, 700px\" \/><\/div><div class=\"phb-content text-left \">\n                  <h5 >Choosing Maintenance Strategy<\/h5>\n                  <p ><\/p><\/div><\/a><\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;]<div class=\"kd-photobox  \" ><a href=\"https:\/\/limblecmms.com\/blog\/maintenance-strategy\/\"  title=\"Read More\"><div class=\"photobox-img\"><img loading=\"lazy\" decoding=\"async\" width=\"700\" height=\"700\" src=\"https:\/\/limblecmms.com\/wp-content\/uploads\/Ultimate-Guide-To-Reliability-Centered-Maintenance.png\" class=\"attachment-full\" alt=\"reliability centered maintenance\" title=\"Ultimate Guide To Reliability Centered Maintenance\" srcset=\"https:\/\/limblecmms.com\/wp-content\/uploads\/Ultimate-Guide-To-Reliability-Centered-Maintenance.png 700w, https:\/\/limblecmms.com\/wp-content\/uploads\/Ultimate-Guide-To-Reliability-Centered-Maintenance-300x300.png 300w, https:\/\/limblecmms.com\/wp-content\/uploads\/Ultimate-Guide-To-Reliability-Centered-Maintenance-150x150.png 150w, https:\/\/limblecmms.com\/wp-content\/uploads\/Ultimate-Guide-To-Reliability-Centered-Maintenance-320x320.png 320w\" sizes=\"auto, (max-width: 700px) 100vw, 700px\" \/><\/div><div class=\"phb-content text-left \">\n                  <h5 >5 Types of Maintenance Strategies<\/h5>\n                  <p ><\/p><\/div><\/a><\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;]<div class=\"kd-photobox  \" ><a href=\"https:\/\/limblecmms.com\/cmms\/\"  title=\"Read More\"><div class=\"photobox-img\"><img loading=\"lazy\" decoding=\"async\" width=\"700\" height=\"700\" src=\"https:\/\/limblecmms.com\/wp-content\/uploads\/IIoT-Technology-Applications-for-Maintenance-and-Asset-Management.jpg\" class=\"attachment-full\" alt=\"iiot maintenance\" title=\"IIoT Technology Applications for Maintenance and Asset Management\" srcset=\"https:\/\/limblecmms.com\/wp-content\/uploads\/IIoT-Technology-Applications-for-Maintenance-and-Asset-Management.jpg 700w, https:\/\/limblecmms.com\/wp-content\/uploads\/IIoT-Technology-Applications-for-Maintenance-and-Asset-Management-300x300.jpg 300w, https:\/\/limblecmms.com\/wp-content\/uploads\/IIoT-Technology-Applications-for-Maintenance-and-Asset-Management-150x150.jpg 150w, https:\/\/limblecmms.com\/wp-content\/uploads\/IIoT-Technology-Applications-for-Maintenance-and-Asset-Management-320x320.jpg 320w\" sizes=\"auto, (max-width: 700px) 100vw, 700px\" \/><\/div><div class=\"phb-content text-left \">\n                  <h5 >What is CMMS?<\/h5>\n                  <p ><\/p><\/div><\/a><\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row kd_background_image_position=&#8221;vc_row-bg-position-top&#8221;][vc_column][vc_raw_html]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[\/vc_raw_html][\/vc_column][\/vc_row][vc_row kd_background_image_position=&#8221;vc_row-bg-position-top&#8221;][vc_column][vc_column_text]<br \/>\n[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row full_width=&#8221;stretch_row&#8221; kd_background_image_position=&#8221;vc_row-bg-position-top&#8221; css=&#8221;.vc_custom_1734562083174{background: #001939 url(https:\/\/limblecmms.com\/wp-content\/uploads\/blog-header-hex-bg4.webp?id=9266) !important;background-position: 0 0 !important;background-repeat: [&hellip;]<\/p>\n","protected":false},"author":77,"featured_media":0,"parent":10098,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"categories":[471],"tags":[],"class_list":["post-14338","page","type-page","status-publish","hentry","category-maintenance-definitions"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.7.1 (Yoast SEO v25.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>What is 21 CFR (Code of Federal Regulation)? | Limble CMMS<\/title>\n<meta name=\"description\" content=\"Everything you ever needed to know about 21 CFR and how it can help improve your maintenance operation today. 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