{"id":10494,"date":"2021-10-04T09:09:00","date_gmt":"2021-10-04T07:09:00","guid":{"rendered":"https:\/\/www.s4bt.it\/principles-alcoa-data-integrity\/"},"modified":"2023-07-20T12:36:07","modified_gmt":"2023-07-20T10:36:07","slug":"principles-alcoa-data-integrity","status":"publish","type":"post","link":"https:\/\/www.s4bt.it\/en\/principles-alcoa-data-integrity\/","title":{"rendered":"What are the ALCOA principles and why are they crucial in Data Integrity?"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"10494\" class=\"elementor elementor-10494 elementor-1339\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-314eb33a elementor-section-height-min-height elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"314eb33a\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wider\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-31fff20a\" data-id=\"31fff20a\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-70676ab elementor-widget elementor-widget-heading\" data-id=\"70676ab\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">BLOG<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-16b6d678 elementor-widget-divider--separator-type-pattern elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"16b6d678\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\" style=\"--divider-pattern-url: url(&quot;data:image\/svg+xml,%3Csvg xmlns=&#039;http:\/\/www.w3.org\/2000\/svg&#039; preserveAspectRatio=&#039;none&#039; overflow=&#039;visible&#039; height=&#039;100%&#039; viewBox=&#039;0 0 20 16&#039; fill=&#039;none&#039; stroke=&#039;black&#039; stroke-width=&#039;1&#039; stroke-linecap=&#039;square&#039; stroke-miterlimit=&#039;10&#039;%3E%3Cg transform=&#039;translate(-12.000000, 0)&#039;%3E%3Cpath d=&#039;M28,0L10,18&#039;\/%3E%3Cpath d=&#039;M18,0L0,18&#039;\/%3E%3Cpath d=&#039;M48,0L30,18&#039;\/%3E%3Cpath d=&#039;M38,0L20,18&#039;\/%3E%3C\/g%3E%3C\/svg%3E&quot;);\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-66232384 elementor-hidden-desktop elementor-hidden-tablet elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"66232384\" data-element_type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">What are the ALCOA principles and why are they crucial in Data Integrity?<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-57daedd elementor-hidden-phone elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"57daedd\" data-element_type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">What are the ALCOA principles and why are they crucial in Data Integrity?<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f4307c1 elementor-widget elementor-widget-post-info\" data-id=\"f4307c1\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-b0a0713 elementor-inline-item\" itemprop=\"author\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.s4bt.it\/en\/author\/silvia\/\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-user-circle\"><\/i>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-author\">\n\t\t\t\t\t\t\t\t\t\tSilvia Di Gennaro\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-92e643a elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.s4bt.it\/en\/2021\/10\/04\/\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-calendar\"><\/i>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\t<time>04\/10\/2021<\/time>\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1d89f449 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1d89f449\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-extended\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-357d2225\" data-id=\"357d2225\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-69e3695 elementor-widget elementor-widget-text-editor\" data-id=\"69e3695\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The ALCOA principles are an important reference model in the pharmaceutical sector, and ensure the integrity of both printed and electronic data.<\/p><h2>Data Integrity<\/h2><p>There is no single definition of Data Integrity, but the various bodies have given similar definitions, with the ALCOA principles at the centre.<\/p><p>According to the World Health Organisation (WHO):<\/p><p>\u201cData integrity is the degree to which data are complete, consistent, accurate, trustworthy, reliable and that these characteristics of the data are maintained throughout the data life cycle. The data should be collected and maintained in a secure manner, so that they are attributable, legible, contemporaneously recorded, original (or a true copy) and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices\u201d.<\/p><p>The definition is also used by MHRA, the regulatory agency for medicines and health products in the UK.<\/p><p>We find a similar definition in the <a href=\"https:\/\/www.fda.gov\/media\/119267\/download\" target=\"_blank\" rel=\"noreferrer noopener\">FDA document<\/a> \u201cData Integrity and Compliance with Drug CGMP. Questions and Answers Guidance for Industry&#8221;:<\/p><p>\u201cData integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA)\u201d.<\/p><h2>ALCOA+ principles<\/h2><p>According to the FDA guidelines, ALCOA stands for <strong>Attributable<\/strong>, <strong>Legible<\/strong>, <strong>Contemporaneous<\/strong>, <strong>Original<\/strong> and <strong>Accurate<\/strong>.<\/p><p>In recent years, these five principles have been supplemented with four more: <strong>Complete<\/strong>, <strong>Consistent<\/strong>, <strong>Enduring<\/strong> and <strong>Available<\/strong>. This is why we talk about <strong>ALCOA+<\/strong>.<\/p><h3>Attributable<\/h3><div>\u00a0<\/div><p>&#8220;Who acquired the data or performed an action following the acquisition, and when?&#8221;<\/p><p>All data created or collected must be <strong>attributable to a person<\/strong> or <strong>computer system<\/strong>. This includes who performed the action and when, thus recording the collection or generation date. Recording can be done manually on paper or automatically through the audit trail in a computer system.<\/p><h3>Legible<\/h3><p>&#8220;Can you read the data and all the metadata or all the manual transcripts on paper?&#8221;<\/p><p>All recorded data must be <strong>legible and permanent<\/strong>, ensuring that it is easily accessible throughout the data lifecycle. This aspect of the data is certainly more easily manageable through electronic systems than on paper.<\/p><h3>Contemporaneous<\/h3><div>\u00a0<\/div><p>&#8220;Is the action documented (on paper or electronically) at the same time as the activity?&#8221;<\/p><p>It is essential that individuals or systems record the data at <b>the very moment in which the activity or sequence of activities is carried out<\/b>. This is a common practice with automated electronic systems, whereas on paper it is more subject to backdating or postdating.<\/p><h3>Original<\/h3><div>\u00a0<\/div><p>&#8220;Certified compliant printouts or copies, electronic records of an activity including the metadata&#8221;<\/p><p>The data should be original rather than copies or transcripts. This is especially true for paper records. For example, it is not appropriate to write partial information on a piece of paper, with the intention of completing the record later on in an official document, as this can cause errors. The original record of the data should appear on the master record, regardless of whether that record is on paper or on a digital system.<\/p><h3>Accurate<\/h3><div>\u00a0<\/div><p>The data should reflect the reality of what actually happened, be complete and error-free.<\/p><p>Any changes must not obscure or erase the original information. The use of a corrector on paper records is therefore not permitted. Any <b>changes <\/b>, whether made electronically or on paper, must be signed by the person making the change, <b>dated and provided with a written explanation<\/b>.<\/p><h3>Complete<\/h3><div>\u00a0<\/div><p>Omissions are regulatory violations! Omission is not so different from &#8220;hiding&#8221;<\/p><p>A record must contain <b>all the information available<\/b> up to that moment. All electronically recorded data requires proof that no information has been deleted or lost.<\/p><h3>Consistent<\/h3><div>\u00a0<\/div><p>The data\/document must be consistent with the use made of it and with the specific features it is expected to have.<\/p><h3>Enduring<\/h3><div>\u00a0<\/div><p>The data\/document must be long-lasting and therefore adequately <b>preserved<\/b>.<\/p><h3>Available<\/h3><div>\u00a0<\/div><p>The data must not only exist, it must be <b>accessible<\/b>. Electronic data recording is normally the most efficient way to achieve this.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-21ad015\" data-id=\"21ad015\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-555afa25 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"555afa25\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-31299f8c\" data-id=\"31299f8c\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_gallery&quot;:[{&quot;id&quot;:6084,&quot;url&quot;:&quot;https:\\\/\\\/www.s4bt.it\\\/wp-content\\\/uploads\\\/2021\\\/06\\\/computer-system-validation-data-integrity.jpg&quot;}],&quot;background_slideshow_loop&quot;:&quot;yes&quot;,&quot;background_slideshow_slide_duration&quot;:5000,&quot;background_slideshow_slide_transition&quot;:&quot;fade&quot;,&quot;background_slideshow_transition_duration&quot;:500}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-220a1457 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"220a1457\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.s4bt.it\/en\/consulting\/computer-system-validation-data-integrity\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">CSV &amp; DATA INTEGRITY CONSULTING<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-65493211 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"65493211\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-3032bb5c\" data-id=\"3032bb5c\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-72f3fe42 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"72f3fe42\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">MORE INFO<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-27b7c6fe elementor-widget elementor-widget-text-editor\" data-id=\"27b7c6fe\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><a href=\"https:\/\/www.s4bt.it\/gestione-del-capa\/\"><em>Discovering CAPA. 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important reference model in the pharmaceutical sector, and ensure the integrity of both printed and electronic data. Data Integrity There is no single definition of Data Integrity, but the various bodies have given similar definitions, with the ALCOA principles at the centre. According to the World Health Organisation (WHO): [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":10498,"comment_status":"closed","ping_status":"closed","sticky":true,"template":"elementor_header_footer","format":"standard","meta":{"footnotes":""},"categories":[26,44],"tags":[],"class_list":["post-10494","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-life-science","category-life-science-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>What are the ALCOA principles and why are they crucial in Data Integrity?<\/title>\n<meta name=\"description\" content=\"The ALCOA+ principles are an important reference model for ensuring Data Integrity in the pharmaceutical sector.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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