{"id":14332,"date":"2023-09-14T11:27:37","date_gmt":"2023-09-14T17:27:37","guid":{"rendered":"https:\/\/limblecmms.com\/?page_id=14332"},"modified":"2025-03-24T13:55:01","modified_gmt":"2025-03-24T19:55:01","slug":"equipment-validation","status":"publish","type":"page","link":"https:\/\/limblecmms.com\/learn\/definitions\/equipment-validation\/","title":{"rendered":"Equipment Validation"},"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_1686168792651{background: #152232 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_1694712056554\" ><h1 class=\"separator_off\" style=\"color: #ffffff;font-size: 50;\">Equipment Validation<\/h1><h2 class=\"subtitle\" style=\"color: #ffffff;font-size:15px;\">Everything you ever needed to know about equipment validation<\/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_1742846099520\" ><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 March 24, 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>What is equipment validation?<\/h2>\n<p><span style=\"font-weight: 400;\">Equipment validation is the process of validating the requirements, specifications, and uses of a piece of equipment to ensure it meets user needs as well as various regulatory and safety requirements. The equipment validation process is usually done to meet quality management standards, such as <\/span><a href=\"https:\/\/www.iso.org\/standard\/59752.html\"><span style=\"font-weight: 400;\">ISO 13485<\/span><\/a><span style=\"font-weight: 400;\"> and <\/span><a href=\"https:\/\/www.iso.org\/iso-9001-quality-management.html\"><span style=\"font-weight: 400;\">ISO 9001<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Businesses typically employ third-party experts to develop and implement a validation plan that helps reduce time and expenses for personnel and other overhead costs. Moreover, validation experts can quickly perform validation activities, and interpret potentially vague regulations, reducing misinterpretation risks.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Equipment validation is a fundamental component of <\/span><a href=\"https:\/\/toolbox.eupati.eu\/resources\/good-practice-gxp\/\"><span style=\"font-weight: 400;\">good practices (GxP)<\/span><\/a><span style=\"font-weight: 400;\"> \u2014 including <\/span><a href=\"https:\/\/www.fda.gov\/drugs\/pharmaceutical-quality-resources\/facts-about-current-good-manufacturing-practices-cgmps\"><span style=\"font-weight: 400;\">Current Good Manufacturing Practice (CGMP) Regulations<\/span><\/a><span style=\"font-weight: 400;\"> \u2014 and the ideal way for high-risk industries to ensure dependable product quality.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Validation is mandatory for certain quality standard certifications (like ISO 13485) that regulators meticulously investigate during <\/span><a href=\"https:\/\/limblecmms.com\/blog\/asset-audit\/\"><span style=\"font-weight: 400;\">asset audits<\/span><\/a><span style=\"font-weight: 400;\">.<\/span>[\/vc_column_text][\/vc_column][\/vc_row][vc_row content_placement=&#8221;middle&#8221; kd_background_image_position=&#8221;vc_row-bg-position-bottom&#8221; kd_top_separator_style=&#8221;skew-left&#8221; kd_top_separator_height=&#8221;separator-height-small&#8221; kd_bottom_separator_style=&#8221;skew-left&#8221; kd_bottom_separator_height=&#8221;separator-height-small&#8221; kd_top_separator=&#8221;true&#8221; kd_bottom_separator=&#8221;true&#8221; css=&#8221;.vc_custom_1682969636891{margin-bottom: 40px !important;padding-top: 120px !important;padding-right: 40px !important;padding-bottom: 50px !important;padding-left: 40px !important;background: #dde4e8 url(https:\/\/limblecmms.com\/wp-content\/uploads\/cta-laired-hex-4.webp?id=9077) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;border-radius: 0px !important;}&#8221; css_tablet_landscape=&#8221;.vc_custom_1682969636891{padding-bottom: 80px !important;}&#8221; css_tablet_portrait=&#8221;.vc_custom_1682969636891{padding-bottom: 80px !important;}&#8221; css_mobile=&#8221;.vc_custom_1682969636892{padding-bottom: 80px !important;}&#8221;][vc_column][vc_row_inner kd_background_image_position=&#8221;vc_row-bg-position-top&#8221;][vc_column_inner]<header class=\"kd-section-title col-lg-12 text-center  subtitle-below-title kd-animated fadeIn   vc_custom_1687971311556\" data-animation-delay=200><h2 class=\"separator_off\" style=\"font-size: 42px;font-weight: 500;margin-bottom:30px;\">The Essential Guide to CMMS<\/h2><h6 class=\"subtitle\" style=\"color: #152232;\">Download this helpful guide to everything a CMMS has to offer.<\/h6><\/header>[\/vc_column_inner][\/vc_row_inner][vc_row_inner content_placement=&#8221;top&#8221; kd_background_image_position=&#8221;vc_row-bg-position-top&#8221;][vc_column_inner width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1631866454223{padding-right: 50px !important;padding-left: 0px !important;}&#8221; offset=&#8221;vc_col-lg-6 vc_col-md-12 vc_col-xs-12&#8243; css_tablet_landscape=&#8221;.vc_custom_1631866454223{padding-right: 0px !important;}&#8221; css_tablet_portrait=&#8221;.vc_custom_1631866454223{padding-right: 0px !important;}&#8221; css_mobile=&#8221;.vc_custom_1631866454224{padding-right: 15px !important;}&#8221;][vc_raw_html]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[\/vc_raw_html][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_single_image source=&#8221;external_link&#8221; alignment=&#8221;center&#8221; css_animation=&#8221;fadeIn&#8221; custom_src=&#8221;https:\/\/3975608.fs1.hubspotusercontent-na1.net\/hubfs\/3975608\/Content%20Downloads\/CMMS%20Guide%20mockup.png&#8221;][\/vc_column_inner][\/vc_row_inner][\/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 style=\"font-weight: 400;\">Table of Contents<\/span><\/h2>\n<p><a href=\"#process\"><span style=\"font-weight: 400;\">Which industries implement equipment validation?<\/span><\/a><br \/>\n<a href=\"#types\">Why is validation important?<\/a><br \/>\n<a href=\"#effort\">Phases of the equipment validation process<\/a><br \/>\n<a href=\"#practices\">Equipment validation best practices<\/a><br \/>\n<a href=\"#last\">Validate your equipment<\/a>[\/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\">Which industries implement equipment validation?<\/h2>\n<p><span style=\"font-weight: 400;\">Many industries use equipment validating processes, including \u2014 but not limited to:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Biotechnology manufacturing and distribution<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Research facilities and laboratories<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Automotive manufacturing<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Computer software development<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Environmental monitoring.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Due to consumer safety concerns, any industries regulated by GxP standards must undergo formal validation. Such industries include:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Medical devices and pharmaceuticals (development, testing, and distribution)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Food storage and distribution<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Aerospace manufacturing and maintenance.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">In addition, the biotechnology industry has specific guidelines which are noted on the <\/span><a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-guides\/biotechnology-inspection-guide-1191\"><span style=\"font-weight: 400;\">FDA website<\/span><\/a>[\/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\">Why is validation important?<\/h2>\n<p><span style=\"font-weight: 400;\">The equipment validation process requires lots of money, time, planning, and knowledge. Nonetheless, it is essential as it guarantees reliable product quality, resulting in fewer recalls and higher customer satisfaction.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Violations can significantly affect companies and consumers, resulting in:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Revenue loss<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Large product recalls<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Costly lawsuits<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Government fines.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Noncompliance with FDA regulations can hinder the authorization process and delay release of certain products such as medicines, new supplements, and the like.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Companies often fail to implement good practices \u2014 created for assuring consumer safety and lowering risk \u2014 with violations becoming increasingly common over the past decade.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For instance, in 2018 the pharmaceutical industry received five times the number of warning letters from the FDA for violations, compared to the number of warnings received in 2015.<\/span>[\/vc_column_text][\/vc_column][\/vc_row][vc_row content_placement=&#8221;middle&#8221; kd_background_image_position=&#8221;vc_row-bg-position-bottom&#8221; kd_top_separator_style=&#8221;skew-left&#8221; kd_top_separator_height=&#8221;separator-height-small&#8221; kd_bottom_separator_style=&#8221;skew-left&#8221; kd_bottom_separator_height=&#8221;separator-height-small&#8221; kd_top_separator=&#8221;true&#8221; kd_bottom_separator=&#8221;true&#8221; css=&#8221;.vc_custom_1686261013744{margin-bottom: 40px !important;padding-top: 120px !important;padding-right: 40px !important;padding-bottom: 50px !important;padding-left: 40px !important;background: #dde4e8 url(https:\/\/limblecmms.com\/wp-content\/uploads\/cta-laired-hex-4.webp?id=9077) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;border-radius: 0px !important;}&#8221; css_tablet_landscape=&#8221;.vc_custom_1686261013744{padding-bottom: 80px !important;}&#8221; css_tablet_portrait=&#8221;.vc_custom_1686261013744{padding-bottom: 80px !important;}&#8221; css_mobile=&#8221;.vc_custom_1686261013744{padding-bottom: 80px !important;}&#8221;][vc_column][vc_row_inner kd_background_image_position=&#8221;vc_row-bg-position-top&#8221;][vc_column_inner]<header class=\"kd-section-title col-lg-12 text-center  subtitle-below-title kd-animated fadeIn   vc_custom_1682969418332\" data-animation-delay=200><h2 class=\"separator_off\" style=\"font-size: 42px;font-weight: 500;margin-bottom:30px;\">Guide to Moving from Reactive to Preventive Maintenance<\/h2><h6 class=\"subtitle\" style=\"color: #152232;\">Want to transition away from costly reactive maintenance but don't know where to start? This guide has everything you need to know.<\/h6><\/header>[\/vc_column_inner][\/vc_row_inner][vc_row_inner content_placement=&#8221;top&#8221; kd_background_image_position=&#8221;vc_row-bg-position-top&#8221;][vc_column_inner width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1631866454223{padding-right: 50px !important;padding-left: 0px !important;}&#8221; offset=&#8221;vc_col-lg-6 vc_col-md-12 vc_col-xs-12&#8243; css_tablet_landscape=&#8221;.vc_custom_1631866454223{padding-right: 0px !important;}&#8221; css_tablet_portrait=&#8221;.vc_custom_1631866454223{padding-right: 0px !important;}&#8221; css_mobile=&#8221;.vc_custom_1631866454224{padding-right: 15px !important;}&#8221;][vc_raw_html]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[\/vc_raw_html][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_single_image source=&#8221;external_link&#8221; alignment=&#8221;center&#8221; css_animation=&#8221;fadeIn&#8221; custom_src=&#8221;https:\/\/3975608.fs1.hubspotusercontent-na1.net\/hubfs\/3975608\/Content%20Downloads\/Reactive%20to%20Preventive%20Guide%20mockup.png&#8221;][\/vc_column_inner][\/vc_row_inner][\/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=\"effort\">Phases of the equipment validation process<\/h2>\n<p><span style=\"font-weight: 400;\">The validation process includes three main phases:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Pre-validation<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Process validation<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Validation maintenance.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Each of these phases has sub-stages or types of equipment validation which we\u2019ll discuss later in the article.<br \/>\n<img loading=\"lazy\" decoding=\"async\" class=\"aligncenter \" src=\"https:\/\/limblecmms.com\/wp-content\/uploads\/Phases-of-the-equipment-validation-scaled.webp\" width=\"500\" height=\"400\" \/><br \/>\n<\/span><\/p>\n<h3><span style=\"font-weight: 400;\">1. Pre-validation of equipment<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">The first phase of the process is pre-validation, which defines whether the equipment can operate within the desired environment as intended per the user\u2019s requirements. You\u2019ll have to consider the needs of the overall process to determine the equipment specifications.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The pre-validation phase has two validation stages:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Design Qualification (DQ)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Installation Qualification (IQ).<\/span><\/li>\n<\/ul>\n<h4><b>Design Qualification<\/b><\/h4>\n<p><span style=\"font-weight: 400;\">Design qualification is the process of demonstrating that the equipment functions appropriately and within prescribed parameters. The DQ stage may include several validations, such as:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">User Requirements Specification (URS)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Functional Specification<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Factory Acceptance Test (FAT)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Operational Specification<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Vendor Qualification<\/span><\/li>\n<\/ul>\n<h4><b>Installation Qualification<\/b><\/h4>\n<p><span style=\"font-weight: 400;\">Installation qualification ensures equipment is installed properly and the environment is appropriate for equipment use.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Manufacturer specifications, such as environmental requirements (humidity and temperature), or electrical requirements (frequency and voltage ratings), are referenced to execute this stage.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The IQ stage may include the following:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Installation of hardware and software<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Confirming and recording proper equipment configuration and installation\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Site Acceptance Test (SAT).<\/span><\/li>\n<\/ul>\n<h3><span style=\"font-weight: 400;\">2. Process validation of equipment<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">This phase involves running repeated trials, mimicking the required performance of the equipment to confirm that it consistently complies with the predetermined conditions for operation and quality.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The process validation phase is executed in two stages:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Operational Qualification (OQ)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Performance Qualification (PQ).<\/span><\/li>\n<\/ul>\n<h4><b>Operational Qualification<\/b><\/h4>\n<p><span style=\"font-weight: 400;\">This step is an inspection of the overall equipment functionality, which includes testing general operations and verifying proper function within the specified parameters.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The goal is to document that the equipment indeed performs according to the required specifications. The OQ stage typically includes:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Security tests<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Setting limits for analytical control<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Functional tests<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Verification of operation in certain simulated conditions.<\/span><\/li>\n<\/ul>\n<h4><b>Performance Qualification<\/b><\/h4>\n<p><span style=\"font-weight: 400;\">This stage demonstrates that the equipment\u2019s functions, per requirements, are relevant to routine use. In this stage, equipment must pass distinct tests, proving it will dependably perform its daily tasks on an ongoing basis.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The PQ stage normally includes the following:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Specified application testing<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ongoing performance of the equipment<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Confirming adherence to industry requirements and standards.<\/span><\/li>\n<\/ul>\n<h3><span style=\"font-weight: 400;\">3. Validation maintenance<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">The third phase of the process is known as post-validation maintenance or <\/span><i><span style=\"font-weight: 400;\">revalidation<\/span><\/i><span style=\"font-weight: 400;\">. If the earlier steps don\u2019t lead to the desired outcome, you need to make the necessary changes to address why.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The validation maintenance phase implements constant equipment monitoring, running performance tests, and verifying that the overall function produces the intended result.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Parameter windows are refined, and equipment is re-qualified and recertified to maintain validation.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In this case, a range of alterations may be required depending on the specific performance issue, and may involve making changes to the following before re-qualification:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Equipment<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Materials or parts<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Packing material<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Manufacturing process.<\/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=\"practices\">Equipment validation best practices<\/h2>\n<p><span style=\"font-weight: 400;\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter \" src=\"https:\/\/limblecmms.com\/wp-content\/uploads\/Equipment-validation-best-practices-scaled.webp\" width=\"499\" height=\"293\" \/><br \/>\nTo ensure an effective equipment qualification process that meets the required quality standards, follow the best practices below. This will help reduce <\/span><a href=\"https:\/\/limblecmms.com\/maintenance-definitions\/downtime\/\"><span style=\"font-weight: 400;\">equipment downtime<\/span><\/a><span style=\"font-weight: 400;\">, prevent product recalls, and avoid costly regulatory fines.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Train personnel:<\/b><span style=\"font-weight: 400;\"> Ensure personnel involved in equipment validation are competent for the job. This includes training related to validation plans, protocols, and procedures.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Have an appropriate validation protocol in place:<\/b><span style=\"font-weight: 400;\"> A document that outlines the process that needs to be validated, including the production equipment and the methodology for conducting the validation.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Follow good documentation practices:<\/b><span style=\"font-weight: 400;\"> Adhering to good documentation practices ensures that your documentation \u2014 and your products \u2014 meets industry standards and fulfills quality assurance, regulatory compliance, and other legal responsibilities.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Record the whole validation process: <\/b><span style=\"font-weight: 400;\">Documentation provides a complete record of the equipment validation process and evidence that the process was conducted according to the defined protocols and procedures. It includes performed tests, deviations, changes, and corrective actions taken.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Review and improve the validation process: <\/b><span style=\"font-weight: 400;\">With continuous improvement, you\u2019ll ensure that the equipment remains in compliance, produces high-quality products, and remains competitive in the market.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Use a CMMS:<\/b><span style=\"font-weight: 400;\"> A <\/span><a href=\"https:\/\/limblecmms.com\/cmms\/cmms-software\/\"><span style=\"font-weight: 400;\">CMMS system<\/span><\/a><span style=\"font-weight: 400;\"> will provide real-time data on <\/span><a href=\"https:\/\/limblecmms.com\/metrics\/total-effective-equipment-performance\/\"><span style=\"font-weight: 400;\">equipment performance<\/span><\/a><span style=\"font-weight: 400;\"> and keep a record of all maintenance activities and related documents (protocols, <\/span><a href=\"https:\/\/limblecmms.com\/blog\/standard-operating-procedure-sop\/\"><span style=\"font-weight: 400;\">standard operating procedures (SOPs)<\/span><\/a><span style=\"font-weight: 400;\">, work orders related to equipment validation, etc.). It will ensure the equipment is maintained according to the manufacturer\u2019s recommendations and demonstrate compliance with regulatory requirements.<\/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=\"https:\/\/limblecmms.com\/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]<\/p>\n<h2 id=\"last\">Validate your equipment<\/h2>\n<p><span style=\"font-weight: 400;\">Equipment validation is an important process that ensures the equipment used in highly regulated industries:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Operates effectively<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Meets required standards<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Produces high-quality products.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">If you are under the scrutiny of external auditors, it pays to follow equipment validation best practices.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">To find out more ways to improve equipment performance and <\/span><a href=\"https:\/\/limblecmms.com\/blog\/equipment-reliability\/\"><span style=\"font-weight: 400;\">equipment reliability<\/span><\/a><span style=\"font-weight: 400;\">, keep browsing the <\/span><a href=\"https:\/\/limblecmms.com\/blog\/\"><span style=\"font-weight: 400;\">Limble blog<\/span><\/a><span style=\"font-weight: 400;\">.<\/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\" >Related Content<\/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\/maintenance-definitions\/proactive-maintenance\/\"  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 Proactive Maintenance?<\/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]<\/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_1686168792651{background: #152232 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-14332","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 Equipment Validation? | Limble CMMS<\/title>\n<meta name=\"description\" content=\"Everything you ever needed to know about equipment validation and how it can help 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