{"id":60126,"date":"2022-11-18T16:23:42","date_gmt":"2022-11-18T15:23:42","guid":{"rendered":"https:\/\/www.remorides.com\/project\/caso-di-studio-medical-devices-manifacturer\/"},"modified":"2023-08-04T16:28:49","modified_gmt":"2023-08-04T14:28:49","slug":"case-study-medical-devices-manufacturer","status":"publish","type":"dt_portfolio","link":"https:\/\/www.remorides.com\/en\/project\/case-study-medical-devices-manufacturer\/","title":{"rendered":"Case Study: Medical devices manufacturer"},"content":{"rendered":"<section class=\"wpb-content-wrapper\"><p>[vc_row full_width=&#8221;stretch_row_content_no_spaces&#8221; equal_height=&#8221;yes&#8221; type=&#8221;vc_default&#8221;][vc_column offset=&#8221;vc_col-lg-offset-0 vc_col-lg-12 vc_col-md-offset-0 vc_col-md-12 vc_col-sm-offset-0&#8243; css=&#8221;.vc_custom_1572879615997{padding-bottom: 60px !important;}&#8221;]<style type=\"text\/css\" data-type=\"the7_shortcodes-inline-css\">.shortcode-single-image-wrap.shortcode-single-image-f8760586b8d46aeca45a54a5f7d14bd8.enable-bg-rollover .rollover i,\n.shortcode-single-image-wrap.shortcode-single-image-f8760586b8d46aeca45a54a5f7d14bd8.enable-bg-rollover .rollover-video i {\n  background: -webkit-linear-gradient();\n  background: linear-gradient();\n}\n.shortcode-single-image-wrap.shortcode-single-image-f8760586b8d46aeca45a54a5f7d14bd8 .rollover-icon {\n  font-size: 32px;\n  color: #ffffff;\n  min-width: 44px;\n  min-height: 44px;\n  line-height: 44px;\n  border-radius: 100px;\n  border-style: solid;\n  border-width: 0px;\n}\n.dt-icon-bg-on.shortcode-single-image-wrap.shortcode-single-image-f8760586b8d46aeca45a54a5f7d14bd8 .rollover-icon {\n  background: rgba(255,255,255,0.3);\n  box-shadow: none;\n}\n<\/style><div class=\"shortcode-single-image-wrap shortcode-single-image-f8760586b8d46aeca45a54a5f7d14bd8 alignnone  enable-bg-rollover dt-icon-bg-off\" style=\"margin-top:0px; margin-bottom:0px; margin-left:0px; margin-right:0px; width:1120px;\" data-pretty-share=\"facebook,twitter,pinterest,linkedin\"><div class=\"shortcode-single-image\"><div class=\"fancy-media-wrap  layzr-bg\" style=\"border-radius:25px;\"><img fetchpriority=\"high\" decoding=\"async\" class=\"preload-me lazy-load aspect\" src=\"data:image\/svg+xml,%3Csvg%20xmlns%3D&#39;http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg&#39;%20viewBox%3D&#39;0%200%201120%20496&#39;%2F%3E\" data-src=\"https:\/\/www.remorides.com\/wp-content\/uploads\/2022\/11\/medical1.jpg\" data-srcset=\"https:\/\/www.remorides.com\/wp-content\/uploads\/2022\/11\/medical1.jpg 1120w\" loading=\"eager\" style=\"--ratio: 1120 \/ 496;\" sizes=\"(max-width: 1120px) 100vw, 1120px\" width=\"1120\" height=\"496\"  data-dt-location=\"https:\/\/www.remorides.com\/en\/project\/case-study-medical-devices-manufacturer\/attachment\/medical1-2\/\" style=\"border-radius:25px;\" alt=\"\" \/><\/div><\/div><\/div>[\/vc_column][\/vc_row][vc_row content_placement=&#8221;middle&#8221; css=&#8221;.vc_custom_1668767200988{margin-bottom: 40px !important;}&#8221;][vc_column]<div id=\"ultimate-heading-654869f46bc28f46f\" class=\"uvc-heading ult-adjust-bottom-margin ultimate-heading-654869f46bc28f46f uvc-9392 \" data-hspacer=\"no_spacer\"  data-halign=\"left\" style=\"text-align:left\"><div class=\"uvc-heading-spacer no_spacer\" style=\"top\"><\/div><div class=\"uvc-main-heading ult-responsive\"  data-ultimate-target='.uvc-heading.ultimate-heading-654869f46bc28f46f h2'  data-responsive-json-new='{\"font-size\":\"desktop:20px;\",\"line-height\":\"\"}' ><h2 style=\"--font-weight:theme;color:#141414;margin-bottom:20px;\">Opera Industry helps achieve data integrity requirements<\/h2><\/div><\/div>[\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1668767219317{margin-bottom: 30px !important;}&#8221;][vc_column width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1668768264428{background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;border-radius: 25px !important;}&#8221;]<style type=\"text\/css\" data-type=\"the7_shortcodes-inline-css\">.shortcode-single-image-wrap.shortcode-single-image-208632de143378d2fb595cc53ca42dc3.enable-bg-rollover .rollover i,\n.shortcode-single-image-wrap.shortcode-single-image-208632de143378d2fb595cc53ca42dc3.enable-bg-rollover .rollover-video i {\n  background: -webkit-linear-gradient();\n  background: linear-gradient();\n}\n.shortcode-single-image-wrap.shortcode-single-image-208632de143378d2fb595cc53ca42dc3 .rollover-icon {\n  font-size: 32px;\n  color: #ffffff;\n  min-width: 44px;\n  min-height: 44px;\n  line-height: 44px;\n  border-radius: 100px;\n  border-style: solid;\n  border-width: 0px;\n}\n.dt-icon-bg-on.shortcode-single-image-wrap.shortcode-single-image-208632de143378d2fb595cc53ca42dc3 .rollover-icon {\n  background: rgba(255,255,255,0.3);\n  box-shadow: none;\n}\n<\/style><div class=\"shortcode-single-image-wrap shortcode-single-image-208632de143378d2fb595cc53ca42dc3 alignnone  enable-bg-rollover dt-icon-bg-off\" style=\"margin-top:0px; margin-bottom:0px; margin-left:0px; margin-right:0px; width:500px;\" data-pretty-share=\"facebook,twitter,pinterest,linkedin\"><div class=\"shortcode-single-image\"><div class=\"fancy-media-wrap  layzr-bg\" style=\"\"><img decoding=\"async\" class=\"preload-me lazy-load aspect\" src=\"data:image\/svg+xml,%3Csvg%20xmlns%3D&#39;http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg&#39;%20viewBox%3D&#39;0%200%20500%20280&#39;%2F%3E\" data-src=\"https:\/\/www.remorides.com\/wp-content\/uploads\/2022\/11\/medical2-500x280.jpg\" data-srcset=\"https:\/\/www.remorides.com\/wp-content\/uploads\/2022\/11\/medical2-500x280.jpg 500w, https:\/\/www.remorides.com\/wp-content\/uploads\/2022\/11\/medical2.jpg 800w\" loading=\"eager\" style=\"--ratio: 500 \/ 280;\" sizes=\"(max-width: 500px) 100vw, 500px\" width=\"500\" height=\"280\"  data-dt-location=\"https:\/\/www.remorides.com\/en\/project\/case-study-medical-devices-manufacturer\/attachment\/in-laboratory-scientists-in-protective-clothes-doing-research-using-microscope-and-entering-data-into-personal-computer-modern-manufactory-producing-semiconductors-and-pharmaceutical-items-2\/\" style=\"\" alt=\"\" \/><\/div><\/div><\/div>[\/vc_column][vc_column width=&#8221;1\/2&#8243;]<div id=\"ultimate-heading-403669f46bc28fc8d\" class=\"uvc-heading ult-adjust-bottom-margin ultimate-heading-403669f46bc28fc8d uvc-8220 \" data-hspacer=\"no_spacer\"  data-halign=\"left\" style=\"text-align:left\"><div class=\"uvc-heading-spacer no_spacer\" style=\"top\"><\/div><div class=\"uvc-main-heading ult-responsive\"  data-ultimate-target='.uvc-heading.ultimate-heading-403669f46bc28fc8d h3'  data-responsive-json-new='{\"font-size\":\"desktop:16px;\",\"line-height\":\"\"}' ><h3 style=\"--font-weight:theme;color:#184996;margin-bottom:20px;\">Introduction<\/h3><\/div><\/div>[vc_column_text]Leading companies in the production of highly critical medical devices have achieved <a title=\"biotech industry compliance\" href=\"https:\/\/www.remorides.com\/en\/industries\/medical-pharma-and-biotech-industry\/\">compliance with data integrity requirements<\/a> through the adoption of Opera Industry integrated with instruments, laboratory machines and business management systems.[\/vc_column_text][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1668767232300{margin-bottom: 30px !important;}&#8221;][vc_column width=&#8221;1\/2&#8243;]<div id=\"ultimate-heading-49369f46bc28fcc7\" class=\"uvc-heading ult-adjust-bottom-margin ultimate-heading-49369f46bc28fcc7 uvc-1867 \" data-hspacer=\"no_spacer\"  data-halign=\"left\" style=\"text-align:left\"><div class=\"uvc-heading-spacer no_spacer\" style=\"top\"><\/div><div class=\"uvc-main-heading ult-responsive\"  data-ultimate-target='.uvc-heading.ultimate-heading-49369f46bc28fcc7 h3'  data-responsive-json-new='{\"font-size\":\"desktop:16px;\",\"line-height\":\"\"}' ><h3 style=\"--font-weight:theme;color:#184996;margin-bottom:20px;\">Regulatory requirements<\/h3><\/div><\/div>[vc_column_text]The FDA expects data used in GMP environments to be in a state of integrity. The concept of data integrity is summarised using the acronym ALCOA, which states that data must be: Attributable, Legible, Contemporaneous (i.e. recorded at the same time as it is produced), Original or a faithful copy and Accurate (ALCOA).[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1668768412502{background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;border-radius: 25px !important;}&#8221;]<style type=\"text\/css\" data-type=\"the7_shortcodes-inline-css\">.shortcode-single-image-wrap.shortcode-single-image-efe29842ae9f1139d6fabfaebd0e4336.enable-bg-rollover .rollover i,\n.shortcode-single-image-wrap.shortcode-single-image-efe29842ae9f1139d6fabfaebd0e4336.enable-bg-rollover .rollover-video i {\n  background: -webkit-linear-gradient();\n  background: linear-gradient();\n}\n.shortcode-single-image-wrap.shortcode-single-image-efe29842ae9f1139d6fabfaebd0e4336 .rollover-icon {\n  font-size: 32px;\n  color: #ffffff;\n  min-width: 44px;\n  min-height: 44px;\n  line-height: 44px;\n  border-radius: 100px;\n  border-style: solid;\n  border-width: 0px;\n}\n.dt-icon-bg-on.shortcode-single-image-wrap.shortcode-single-image-efe29842ae9f1139d6fabfaebd0e4336 .rollover-icon {\n  background: rgba(255,255,255,0.3);\n  box-shadow: none;\n}\n<\/style><div class=\"shortcode-single-image-wrap shortcode-single-image-efe29842ae9f1139d6fabfaebd0e4336 alignnone  enable-bg-rollover dt-icon-bg-off\" style=\"margin-top:0px; margin-bottom:0px; margin-left:0px; margin-right:0px; width:500px;\" data-pretty-share=\"facebook,twitter,pinterest,linkedin\"><div class=\"shortcode-single-image\"><div class=\"fancy-media-wrap  layzr-bg\" style=\"\"><img decoding=\"async\" class=\"preload-me lazy-load aspect\" src=\"data:image\/svg+xml,%3Csvg%20xmlns%3D&#39;http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg&#39;%20viewBox%3D&#39;0%200%20500%20290&#39;%2F%3E\" data-src=\"https:\/\/www.remorides.com\/wp-content\/uploads\/2022\/11\/medical3-500x290.jpg\" data-srcset=\"https:\/\/www.remorides.com\/wp-content\/uploads\/2022\/11\/medical3-500x290.jpg 500w, https:\/\/www.remorides.com\/wp-content\/uploads\/2022\/11\/medical3.jpg 800w\" loading=\"eager\" style=\"--ratio: 500 \/ 290;\" sizes=\"(max-width: 500px) 100vw, 500px\" width=\"500\" height=\"290\"  data-dt-location=\"https:\/\/www.remorides.com\/en\/project\/case-study-medical-devices-manufacturer\/attachment\/close-up-of-machine-for-testing-different-samples-2\/\" style=\"\" alt=\"\" \/><\/div><\/div><\/div>[\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1668767236753{margin-bottom: 30px !important;}&#8221;][vc_column][vc_column_text]The MHRA5 includes other terms to help interpret the acronym. ALCOA is Attributable, Legible, Contemporaneous, Original and Accurate, while the &#8220;+&#8221; refers to being Complete, Consistent, Durable and Available. [\/vc_column_text][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1668767241292{margin-bottom: 30px !important;}&#8221;][vc_column]<div id=\"ultimate-heading-474269f46bc2904dc\" class=\"uvc-heading ult-adjust-bottom-margin ultimate-heading-474269f46bc2904dc uvc-3396 \" data-hspacer=\"no_spacer\"  data-halign=\"left\" style=\"text-align:left\"><div class=\"uvc-heading-spacer no_spacer\" style=\"top\"><\/div><div class=\"uvc-main-heading ult-responsive\"  data-ultimate-target='.uvc-heading.ultimate-heading-474269f46bc2904dc h3'  data-responsive-json-new='{\"font-size\":\"desktop:16px;\",\"line-height\":\"\"}' ><h3 style=\"--font-weight:theme;color:#184996;margin-bottom:20px;\">Data Reliability<\/h3><\/div><\/div>[vc_column_text]Data form the basis of the system that leads to knowledge about a product or process. Consequently, many standards have been developed to ensure the collection of valid data. The sentence &#8216;Garbage in, Garbage out&#8217; was well understood before the advent of computers. The issue of data integrity has focused on the activities of company laboratories, since this is where most data is collected, but it must be remembered that production processes generate data even without the use of laboratory facilities.<br \/>\nThe statement: &#8216;Data must be recorded directly, promptly and legibly&#8217; tells us that the first data record is the &#8216;original data&#8217;. There must be no intermediate records or copies. The term &#8216;promptly&#8217; means that the recording must be made as soon as possible after the generation of the data. Furthermore, if an electronic record is used, it is necessary to have a function of &#8216;change tracking&#8217; that records modifications from the original record.<br \/>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1668767249074{margin-bottom: 30px !important;}&#8221;][vc_column]<div id=\"ultimate-heading-912769f46bc290523\" class=\"uvc-heading ult-adjust-bottom-margin ultimate-heading-912769f46bc290523 uvc-3614 \" data-hspacer=\"no_spacer\"  data-halign=\"left\" style=\"text-align:left\"><div class=\"uvc-heading-spacer no_spacer\" style=\"top\"><\/div><div class=\"uvc-main-heading ult-responsive\"  data-ultimate-target='.uvc-heading.ultimate-heading-912769f46bc290523 h3'  data-responsive-json-new='{\"font-size\":\"desktop:16px;\",\"line-height\":\"\"}' ><h3 style=\"--font-weight:theme;color:#184996;margin-bottom:20px;\">Data integrity management process<\/h3><\/div><\/div>[vc_column_text]Customers who have adopted <a title=\"opera industry\" href=\"https:\/\/www.remorides.com\/en\/opera-industry\/\">Opera Industry<\/a> for laboratory and production data integrity management have been able to collect and manage data thanks to the multiple validated communication interfaces that are available.<\/p>\n<p>Our data integrity management process consists of the following steps:<\/p>\n<ul>\n<li>Login of enabled users with P11 compliant accounts<\/li>\n<li>Collection of Raw Data from the tool that generates it<\/li>\n<li>Protection of the raw data during the generation process from any changes<\/li>\n<li>Addition of metadata to characterise the records<\/li>\n<li>Assignment of a unique identification code<\/li>\n<li>Transfer of Raw Data and metadata to a centralised database<\/li>\n<li>Historical record of all accesses and actions performed by users on the electronic record<\/li>\n<li>Data Integrity report with highlights of the electronic record<\/li>\n<\/ul>\n<p>The whole software and integration is validated, including clients, servers and interfaces. All records are subject to automatic Audit Log.[\/vc_column_text][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1668767249074{margin-bottom: 30px !important;}&#8221;][vc_column]<div id=\"ultimate-heading-991369f46bc29055f\" class=\"uvc-heading ult-adjust-bottom-margin ultimate-heading-991369f46bc29055f uvc-872 \" data-hspacer=\"no_spacer\"  data-halign=\"left\" style=\"text-align:left\"><div class=\"uvc-heading-spacer no_spacer\" style=\"top\"><\/div><div class=\"uvc-main-heading ult-responsive\"  data-ultimate-target='.uvc-heading.ultimate-heading-991369f46bc29055f h3'  data-responsive-json-new='{\"font-size\":\"desktop:16px;\",\"line-height\":\"\"}' ><h3 style=\"--font-weight:theme;color:#184996;margin-bottom:20px;\">Connect technologies in the field<\/h3><\/div><\/div>[vc_column_text]The collection of data from the instruments that generate them represents the greatest challenge due to the variety of technologies with which laboratory instruments, test benches, production machines and GMP document management software are made.<\/p>\n<p>Through various interfaces, clients such as:<\/p>\n<ul>\n<li>Labview<\/li>\n<li>Labwindows<\/li>\n<li>C#<\/li>\n<li>MQTT<\/li>\n<li>ModBus<\/li>\n<li>RS232 and RS485<\/li>\n<li>TCP\/IP clients<\/li>\n<li>File system based<\/li>\n<li>Without interfaces<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row equal_height=&#8221;yes&#8221; type=&#8221;vc_default&#8221;][vc_column offset=&#8221;vc_col-lg-offset-0 vc_col-lg-12 vc_col-md-offset-0 vc_col-md-12 vc_col-sm-offset-0&#8243; css=&#8221;.vc_custom_1572879615997{padding-bottom: 60px !important;}&#8221;]<style type=\"text\/css\" data-type=\"the7_shortcodes-inline-css\">.shortcode-single-image-wrap.shortcode-single-image-d065feadad9f014fa1ea8d7d5c964002.enable-bg-rollover .rollover i,\n.shortcode-single-image-wrap.shortcode-single-image-d065feadad9f014fa1ea8d7d5c964002.enable-bg-rollover .rollover-video i {\n  background: -webkit-linear-gradient();\n  background: linear-gradient();\n}\n.shortcode-single-image-wrap.shortcode-single-image-d065feadad9f014fa1ea8d7d5c964002 .rollover-icon {\n  font-size: 32px;\n  color: #ffffff;\n  min-width: 44px;\n  min-height: 44px;\n  line-height: 44px;\n  border-radius: 100px;\n  border-style: solid;\n  border-width: 0px;\n}\n.dt-icon-bg-on.shortcode-single-image-wrap.shortcode-single-image-d065feadad9f014fa1ea8d7d5c964002 .rollover-icon {\n  background: rgba(255,255,255,0.3);\n  box-shadow: none;\n}\n<\/style><div class=\"shortcode-single-image-wrap shortcode-single-image-d065feadad9f014fa1ea8d7d5c964002 alignnone  enable-bg-rollover dt-icon-bg-off\" style=\"margin-top:0px; margin-bottom:0px; margin-left:0px; margin-right:0px; width:1120px;\" data-pretty-share=\"facebook,twitter,pinterest,linkedin\"><div class=\"shortcode-single-image\"><div class=\"fancy-media-wrap  layzr-bg\" style=\"border-radius:25px;\"><img decoding=\"async\" class=\"preload-me lazy-load aspect\" src=\"data:image\/svg+xml,%3Csvg%20xmlns%3D&#39;http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg&#39;%20viewBox%3D&#39;0%200%201120%20630&#39;%2F%3E\" data-src=\"https:\/\/www.remorides.com\/wp-content\/uploads\/2022\/11\/medical4.jpg\" data-srcset=\"https:\/\/www.remorides.com\/wp-content\/uploads\/2022\/11\/medical4.jpg 1120w\" loading=\"eager\" style=\"--ratio: 1120 \/ 630;\" sizes=\"(max-width: 1120px) 100vw, 1120px\" width=\"1120\" height=\"630\"  data-dt-location=\"https:\/\/www.remorides.com\/en\/project\/case-study-medical-devices-manufacturer\/attachment\/shot-in-industrial-design-research-laboratory-specialist-uses-microscope-designer-works-on-personal-computer-female-scientists-writes-on-glass-whiteboard-team-of-developers-work-with-3d-printer-an-2\/\" style=\"border-radius:25px;\" alt=\"\" \/><\/div><\/div><\/div>[\/vc_column][\/vc_row]<\/p>\n<\/section>","protected":false},"excerpt":{"rendered":"<p>Opera Industry helps achieve data integrity requirements<\/p>\n","protected":false},"author":2,"featured_media":58322,"comment_status":"closed","ping_status":"closed","template":"","dt_portfolio_category":[550],"dt_portfolio_tags":[],"class_list":["post-60126","dt_portfolio","type-dt_portfolio","status-publish","has-post-thumbnail","hentry","dt_portfolio_category-medical-pharma-and-biotech","dt_portfolio_category-550","description-off"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Case Study: Production of Medical Devices - Remorides<\/title>\n<meta name=\"description\" content=\"Leading medical device companies have achieved compliance with data integrity requirements thanks to Opera Industry. 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