{"id":50033,"date":"2024-07-16T14:48:09","date_gmt":"2024-07-16T12:48:09","guid":{"rendered":"https:\/\/clariscience.com\/blog\/uncategorized\/il-controllo-delle-registrazioni-del-sgq"},"modified":"2024-11-11T15:26:57","modified_gmt":"2024-11-11T14:26:57","slug":"control-of-quality-management-system-records","status":"publish","type":"post","link":"https:\/\/clariscience.com\/en\/blog\/quality\/control-of-quality-management-system-records","title":{"rendered":"Control of Quality Management System records"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"50033\" class=\"elementor elementor-50033 elementor-46531\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-d227131 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d227131\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&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-top-column elementor-element elementor-element-9b7ba7c\" data-id=\"9b7ba7c\" data-element_type=\"column\" data-e-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-5614d53 elementor-widget elementor-widget-text-editor\" data-id=\"5614d53\" data-element_type=\"widget\" data-e-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>In a previous article, we explained how to <a href=\"https:\/\/clariscience.com\/en\/blog\/uncategorized\/control-of-quality-management-system-documents\">effectively control the documents of the corporate Quality Management System<\/a>; however, equal importance must be given to records.<\/p>\n<p>The data <strong>recording system<\/strong> is designed to <strong>collect the results of all activities<\/strong> performed, all <strong>inspections <\/strong>conducted, and the <strong>outcomes <\/strong>achieved, providing <strong>evidence <\/strong>of compliance with applicable technical and\/or regulatory requirements and the <strong>effective functioning of the Quality Management System.<\/strong><\/p>\n<p>Among the records, we can include, for example:<\/p>\n<ul>\n<li>production batch records<\/li>\n<li>maintenance or service reports<\/li>\n<li>warehouse picking lists<\/li>\n<li>transport documents<\/li>\n<li>supply specifications or Quality Agreements<\/li>\n<li>distribution contracts<\/li>\n<li>training reports<\/li>\n<li>Internal audit plans and reports, whether from second or third parties, as well as any checklists used<\/li>\n<li>Evidence of complaint management<\/li>\n<\/ul>\n<p>What does the ISO 13485 standard\u2014the <em>gold standard<\/em> for Quality Management Systems in the medical field\u2014establish regarding the control of records?<\/p>\n<\/p>\n<h2>\n            <strong>Documented Procedures for Record Management<\/strong><br \/>\n          <\/h2>\n<p>The organization must document <strong>procedures to define the necessary controls<\/strong> to ensure adequate <strong>identification <\/strong>and proper <strong>filing <\/strong>of records, as well as to guarantee their appropriate <strong>retention, security, and integrity. <\/strong>These procedures must also define the <strong>period <\/strong>during which the organization ensures the retention of records and the <strong>method for their disposal.<\/strong> <\/p>\n<p>The procedures should also establish <strong>responsibilities <\/strong>for the completion, approval, and filing of all records.<\/p>\n<\/p>\n<h2>\n            <strong>Proper Completion of Records<\/strong><br \/>\n          <\/h2>\n<p>It is advisable to train all personnel in the organization on the proper completion of records: <strong>all fields<\/strong> should be filled out <strong>clearly, neatly, and in legible handwriting<\/strong>, <strong>without leaving blank spaces.<\/strong><\/p>\n<p><\/p>\n<p>If a field of the record <strong>is not to be completed<\/strong>, it must be clearly <strong>identified <\/strong>(for example, by marking it as <em>N.A. \u2013 Not Applicable<\/em>, or with a <em>slash <\/em>\/) and, if applicable, accompanied by the reason why the operator deemed it non-fillable.<\/p>\n<\/p>\n<h2>\n            <strong>Changes to Records<\/strong><br \/>\n          <\/h2>\n<p><strong>Changes <\/strong>made to records must always remain <strong>identifiable<\/strong>: the use of erasable pencils and erasers or correction fluid (or tape) should not be permitted. If a portion of text needs to be deleted, it should simply be struck through to<strong> accurately identify the original content in all cases.<\/strong> <\/p>\n<p>Additionally, it is good practice to <strong>identify the author of the modification<\/strong> to maintain adequate traceability of responsibilities\/authorities.<\/p>\n<\/p>\n<h2>\n            <strong>Management of Confidential Information<\/strong><br \/>\n          <\/h2>\n<p>The organization must define and implement adequate methods to protect and<strong> safeguard confidential information <\/strong>(not only from clients but also from employees, suppliers, and other external stakeholders) contained in the records, in accordance with applicable regulatory requirements.<\/p>\n<p>It may be useful to sign specific <strong>NDAs<\/strong> (<em>Non-Disclosure Agreements<\/em>) with <strong>stakeholders<\/strong>, defining what is meant by confidential information and how the company intends to manage, treat, and, if necessary, under what specific conditions this information may be communicated and\/or disclosed externally.<\/p>\n<p>Particular attention must be paid to <strong>clinical data<\/strong> and, more generally, to all sensitive data of patients and users processed by the organization in the context of clinical investigations.<\/p>\n<\/p>\n<h2>\n            <strong>Retention of Records<\/strong><br \/>\n          <\/h2>\n<p>The organization must establish the <strong>period <\/strong>during which records of the Quality Management System must be <strong>retained<\/strong>.<\/p>\n<p>The ISO 13485 standard states that all records must be maintained for <strong>at least the life of the medical device<\/strong> for which the organization is the manufacturer\u2014but for <strong>no less than two years from its release<\/strong>\u2014while also <strong>considering <\/strong>the provisions of <strong>EU Regulation 2017\/745<\/strong> and subsequent amendments regarding medical devices (MDR) and\/or other applicable legal requirements. <\/p>\n<p>During this entire period, the <strong>original copies<\/strong> of all records must remain <strong>legible, easily identifiable, and accessible.<\/strong><\/p>\n<p>For this reason, it is good practice to prefer <strong>electronic storage<\/strong> over paper storage. If it is not possible to complete all records electronically, they can be completed by hand and subsequently scanned and stored digitally. If the organization has an electronic archive containing all records, it is also advisable to schedule <strong>periodic backups<\/strong>, thereby reducing the risk of deterioration or loss that paper documents are more prone to.  <\/p>\n<\/p>\n<h2>\n            <strong>Conclusions<\/strong><br \/>\n          <\/h2>\n<p>The control of records is therefore a <strong>critical activity<\/strong> for organizations, as they are the<strong> only documents<\/strong> capable of providing <strong>evidence <\/strong>of compliance with requirements and the effective functioning of the Quality Management System.<\/p>\n<p>The procedures and operational practices for managing records must be clearly defined and without neglecting any detail.<\/p>\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<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>The data recording system aims to collect the results of all activities performed, all checks conducted, and the results obtained, thus providing evidence of compliance with applicable technical and\/or legal requirements and the effective functioning of the Quality Management System.<\/p>\n","protected":false},"author":328,"featured_media":46496,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"episode_type":"","audio_file":"","podmotor_file_id":"","podmotor_episode_id":"","cover_image":"","cover_image_id":"","duration":"","filesize":"","filesize_raw":"","date_recorded":"","explicit":"","block":"","powered_cache_disable_cache":false,"powered_cache_disable_css_optimization":false,"powered_cache_disable_js_optimization":false,"footnotes":""},"categories":[533],"tags":[575],"class_list":["post-50033","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-quality","tag-magazine-en"],"acf":[],"yoast_head":"<title>Magazine<\/title>\n<meta name=\"description\" content=\"The ISO 13485 standard establishes that records related to the Quality Management System (QMS) must be properly controlled to ensure their reliability, accessibility, and compliance. Specifically, the standard requires that:\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/clariscience.com\/en\/blog\/quality\/control-of-quality-management-system-records\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Magazine\" \/>\n<meta property=\"og:description\" content=\"The ISO 13485 standard establishes that records related to the Quality Management System (QMS) must be properly controlled to ensure their reliability, accessibility, and compliance. 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