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When is a Digital 4.0 MES not a Digital 4.0 MES? - Engineers Outlook

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a.penci-recipe-print:hover,.penci-review-metas .penci-review-btnbuy:hover, .home-featured-cat-content.style-14 .magcat-padding:before, .wrapper-boxed .bbp-pagination-links span.current, #buddypress .dir-search input[type=submit], #buddypress .groups-members-search input[type=submit], #buddypress button:hover, #buddypress a.button:hover, #buddypress a.button:focus, #buddypress input[type=button]:hover, #buddypress input[type=reset]:hover, #buddypress ul.button-nav li a:hover, #buddypress ul.button-nav li.current a, #buddypress div.generic-button a:hover, #buddypress .comment-reply-link:hover, #buddypress input[type=submit]:hover, #buddypress div.pagination .pagination-links .current, #buddypress input[type=submit], form.pc-searchform.penci-hbg-search-form input.search-input:hover, form.pc-searchform.penci-hbg-search-form input.search-input:focus, .penci-dropcap-box-outline, .penci-dropcap-circle-outline { border-color: #303f9f; } .woocommerce .woocommerce-error, .woocommerce .woocommerce-info, .woocommerce .woocommerce-message { border-top-color: #303f9f; } .penci-slider ol.penci-control-nav li a.penci-active, .penci-slider ol.penci-control-nav li a:hover, .penci-related-carousel .owl-dot.active span, .penci-owl-carousel-slider .owl-dot.active span{ border-color: #303f9f; background-color: #303f9f; } .woocommerce .woocommerce-message:before, .woocommerce form.checkout table.shop_table .order-total .amount, .woocommerce ul.products li.product .price ins, .woocommerce ul.products li.product .price, .woocommerce div.product p.price ins, .woocommerce div.product span.price ins, .woocommerce div.product p.price, .woocommerce div.product .entry-summary div[itemprop="description"] blockquote:before, .woocommerce div.product .woocommerce-tabs #tab-description blockquote:before, .woocommerce div.product .entry-summary div[itemprop="description"] blockquote cite, .woocommerce div.product .entry-summary div[itemprop="description"] blockquote .author, .woocommerce div.product .woocommerce-tabs #tab-description blockquote cite, .woocommerce div.product .woocommerce-tabs #tab-description blockquote .author, .woocommerce div.product .product_meta > span a:hover, .woocommerce div.product .woocommerce-tabs ul.tabs li.active, .woocommerce ul.cart_list li .amount, .woocommerce ul.product_list_widget li .amount, .woocommerce table.shop_table td.product-name a:hover, .woocommerce table.shop_table td.product-price span, .woocommerce table.shop_table td.product-subtotal span, .woocommerce-cart .cart-collaterals .cart_totals table td .amount, .woocommerce .woocommerce-info:before, .woocommerce div.product span.price, .penci-container-inside.penci-breadcrumb span a:hover,.penci-container-inside.penci-breadcrumb a:hover { color: #303f9f; } .standard-content .penci-more-link.penci-more-link-button a.more-link, .penci-readmore-btn.penci-btn-make-button a, .penci-featured-cat-seemore.penci-btn-make-button a{ background-color: #303f9f; color: #fff; } .penci-vernav-toggle:before{ border-top-color: #303f9f; color: #fff; } #penci-login-popup:before{ opacity: ; } #navigation .penci-megamenu .post-mega-title a, .pc-builder-element .navigation .penci-megamenu .penci-content-megamenu .penci-mega-latest-posts .penci-mega-post .post-mega-title a{ font-size:14px; } #navigation .penci-megamenu .penci-mega-child-categories a, .pc-builder-element.pc-main-menu .navigation .menu li .penci-mega-child-categories a{ font-size: 13px; } #navigation .penci-megamenu .post-mega-title a, .pc-builder-element .navigation .penci-megamenu .penci-content-megamenu .penci-mega-latest-posts .penci-mega-post .post-mega-title a{ text-transform: none; } .penci-header-signup-form { padding-top: px; padding-bottom: px; } .penci-slide-overlay .overlay-link, .penci-slider38-overlay, .penci-flat-overlay .penci-slide-overlay .penci-mag-featured-content:before { opacity: ; } .penci-item-mag:hover .penci-slide-overlay .overlay-link, .featured-style-38 .item:hover .penci-slider38-overlay, .penci-flat-overlay .penci-item-mag:hover .penci-slide-overlay .penci-mag-featured-content:before { opacity: ; } .penci-featured-content .featured-slider-overlay { opacity: ; } .featured-style-29 .featured-slider-overlay { opacity: ; } .penci-wrapper-data .standard-post-image:not(.classic-post-image){ margin-bottom: 0; } .header-standard.standard-overlay-meta{ margin: -30px 30px 19px; background: #fff; padding-top: 25px; padding-left: 5px; padding-right: 5px; z-index: 10; position: relative; } .penci-wrapper-data .standard-post-image:not(.classic-post-image) .audio-iframe, .penci-wrapper-data .standard-post-image:not(.classic-post-image) .standard-content-special{ bottom: 50px; } @media only screen and (max-width: 479px){ .header-standard.standard-overlay-meta{ margin-left: 10px; margin-right: 10px; } } .penci-grid li.typography-style .overlay-typography { opacity: ; } .penci-grid li.typography-style:hover .overlay-typography { opacity: ; } .penci-grid > li, .grid-featured, .penci-grid li.typography-style, .grid-mixed, .penci-grid .list-post.list-boxed-post, .penci-masonry .item-masonry, article.standard-article, .penci-grid li.list-post, .grid-overlay, .penci-grid li.list-post.penci-slistp{ margin-bottom: 20px; } .penci-grid li.list-post, .penci-grid li.list-post.penci-slistp{ padding-bottom: 20px; } .penci-layout-mixed-3 .penci-grid li.penci-slistp, .penci-layout-mixed-4 .penci-grid li.penci-slistp{ padding-bottom: 0px; margin-bottom: 0px; padding-top: 20px; } .penci-layout-mixed-3 .penci-grid li.penci-slistp ~ .penci-slistp, .penci-layout-mixed-4 .penci-grid li.penci-slistp ~ .penci-slistp{ margin-top: 20px; } @media only screen and (min-width: 961px){ .penci-sidebar-content{ width: 26%; } .penci-single-style-10 .penci-single-s10-content, .container.penci_sidebar:not(.two-sidebar) #main{ width: 74%; } } .penci-sidebar-content .penci-border-arrow .inner-arrow { font-size: 14px; } .penci-sidebar-content .penci-border-arrow .inner-arrow, .penci-sidebar-content.style-4 .penci-border-arrow .inner-arrow:before, .penci-sidebar-content.style-4 .penci-border-arrow .inner-arrow:after, .penci-sidebar-content.style-5 .penci-border-arrow, .penci-sidebar-content.style-7 .penci-border-arrow, .penci-sidebar-content.style-9 .penci-border-arrow{ border-color: #ffffff; } .penci-sidebar-content .penci-border-arrow:before { border-top-color: #ffffff; } .penci-sidebar-content.style-16 .penci-border-arrow:after{ background-color: #ffffff; } #footer-section .footer-menu li a { font-size: 14px; } #footer-copyright * { font-size: 13px; } #footer-copyright * { font-style: normal; } .container-single .single-post-title { text-transform: none; } @media only screen and (min-width: 769px){ .container-single .single-post-title { font-size: 40px; } } @media only screen and (max-width: 768px){ .container-single .single-post-title, .container-single.penci-single-style-3 .single-post-title, .container-single.penci-single-style-4 .single-post-title, .container-single.penci-single-style-5 .single-post-title, .container-single.penci-single-style-6 .single-post-title, .container-single.penci-single-style-7 .single-post-title, .container-single.penci-single-style-8 .single-post-title, .container-single.penci-single-style-9 .single-post-title, .container-single.penci-single-style-10 .single-post-title{ font-size: 26px; } } @media only screen and (min-width: 769px){ .container-single .header-standard h2.penci-psub-title, .container-single h2.penci-psub-title{ font-size: 22px; } } @media only screen and (max-width: 768px){ .container-single .header-standard h2.penci-psub-title, .container-single h2.penci-psub-title{ font-size: 18px; } } .post-entry h1, .wpb_text_column h1, .elementor-text-editor h1, .woocommerce .page-description h1{font-size:32px;}.post-entry h2, .wpb_text_column h2, .elementor-text-editor h2, .woocommerce .page-description h2{font-size:28px;}.post-entry h3, .wpb_text_column h3, .elementor-text-editor h3, .woocommerce .page-description h3{font-size:24px;}.post-entry h4, .wpb_text_column h4, .elementor-text-editor h4, .woocommerce .page-description h4{font-size:20px;}.post-entry h5, .wpb_text_column h5, .elementor-text-editor h5, .woocommerce .page-description h5{font-size:16px;} .post-entry blockquote.wp-block-quote p, .wpb_text_column blockquote.wp-block-quote p, .post-entry blockquote, .post-entry blockquote p, .wpb_text_column blockquote, .wpb_text_column blockquote p, .woocommerce .page-description blockquote, .woocommerce .page-description blockquote p{ font-size: 20px; } .author-content h5{ font-size: 16px; } .post-pagination h5{ font-size: 16px; } #respond h3.comment-reply-title span, .post-box-title{ font-size: 20px; } .post-related .item-related h3 a{ font-size: 16px; } .post-related .item-related span.date{ font-size: 12px; } .container-single .single-post-title { } .penci-single-style-6 .single-breadcrumb, .penci-single-style-5 .single-breadcrumb, .penci-single-style-4 .single-breadcrumb, .penci-single-style-3 .single-breadcrumb, .penci-single-style-9 .single-breadcrumb, .penci-single-style-7 .single-breadcrumb{ text-align: left; } .container-single .header-standard, .container-single .post-box-meta-single { text-align: left; } .rtl .container-single .header-standard,.rtl .container-single .post-box-meta-single { text-align: right; } .container-single .post-pagination h5 { text-transform: none; } #respond h3.comment-reply-title span:before, #respond h3.comment-reply-title span:after, .post-box-title:before, .post-box-title:after { content: none; display: none; } .container-single .item-related h3 a { text-transform: none; } .home-featured-cat-content .mag-photo .mag-overlay-photo { opacity: ; } .home-featured-cat-content .mag-photo:hover .mag-overlay-photo { opacity: ; } .inner-item-portfolio:hover .penci-portfolio-thumbnail a:after { opacity: ; } .penci-menuhbg-toggle { width: 18px; } .penci-menuhbg-toggle .penci-menuhbg-inner { height: 18px; } .penci-menuhbg-toggle .penci-lines, .penci-menuhbg-wapper{ width: 18px; } .penci-menuhbg-toggle .lines-button{ top: 8px; } .penci-menuhbg-toggle .penci-lines:before{ top: 5px; } .penci-menuhbg-toggle .penci-lines:after{ top: -5px; } .penci-menuhbg-toggle:hover .lines-button:after, .penci-menuhbg-toggle:hover .penci-lines:before, .penci-menuhbg-toggle:hover .penci-lines:after{ transform: translateX(28px); } .penci-menuhbg-toggle .lines-button.penci-hover-effect{ left: -28px; } .penci-menu-hbg-inner .penci-hbg_sitetitle{ font-size: 18px; } .penci-menu-hbg-inner .penci-hbg_desc{ font-size: 14px; } .penci-menu-hbg{ width: 330px; }.penci-menu-hbg.penci-menu-hbg-left{ transform: translateX(-330px); -webkit-transform: translateX(-330px); -moz-transform: translateX(-330px); }.penci-menu-hbg.penci-menu-hbg-right{ transform: translateX(330px); -webkit-transform: translateX(330px); -moz-transform: translateX(330px); }.penci-menuhbg-open .penci-menu-hbg.penci-menu-hbg-left, .penci-vernav-poleft.penci-menuhbg-open .penci-vernav-toggle{ left: 330px; }@media only screen and (min-width: 961px) { .penci-vernav-enable.penci-vernav-poleft .wrapper-boxed{ padding-left: 330px; } .penci-vernav-enable.penci-vernav-poright .wrapper-boxed{ padding-right: 330px; } .penci-vernav-enable .is-sticky #navigation{ width: calc(100% - 330px); } }@media only screen and (min-width: 961px) { .penci-vernav-enable .penci_is_nosidebar .wp-block-image.alignfull, .penci-vernav-enable .penci_is_nosidebar .wp-block-cover-image.alignfull, .penci-vernav-enable .penci_is_nosidebar .wp-block-cover.alignfull, .penci-vernav-enable .penci_is_nosidebar .wp-block-gallery.alignfull, .penci-vernav-enable .penci_is_nosidebar .alignfull{ margin-left: calc(50% - 50vw + 165px); width: calc(100vw - 330px); } }.penci-vernav-poright.penci-menuhbg-open .penci-vernav-toggle{ right: 330px; }@media only screen and (min-width: 961px) { .penci-vernav-enable.penci-vernav-poleft .penci-rltpopup-left{ left: 330px; } }@media only screen and (min-width: 961px) { .penci-vernav-enable.penci-vernav-poright .penci-rltpopup-right{ right: 330px; } }@media only screen and (max-width: 1500px) and (min-width: 961px) { .penci-vernav-enable .container { max-width: 100%; max-width: calc(100% - 30px); } .penci-vernav-enable .container.home-featured-boxes{ display: block; } .penci-vernav-enable .container.home-featured-boxes:before, .penci-vernav-enable .container.home-featured-boxes:after{ content: ""; display: table; clear: both; } } .mc4wp-form {text-align: left;} .pcab-abrcrb .container.penci-breadcrumb{ margin-top: 0; } .archive-box span, .archive-box h1 { text-transform: uppercase; font-size: 12px; line-height: 1.6em; } @media only screen and (min-width: 900px) and (max-width: 1310px) { body { --pcctain: 1000px!important; }} .side-wauthor a, .bg-date-author a, .sl-date-author, .feat-author a, .featc-author a, .author-url{ pointer-events: none; cursor: default;} .penci-block-vc .penci-border-arrow .inner-arrow { font-size: 14px; } .penci-block-vc .penci-border-arrow .inner-arrow, .penci-block-vc.style-4 .penci-border-arrow .inner-arrow:before, .penci-block-vc.style-4 .penci-border-arrow .inner-arrow:after, .penci-block-vc.style-5 .penci-border-arrow, .penci-block-vc.style-7 .penci-border-arrow, .penci-block-vc.style-9 .penci-border-arrow { border-color: #ffffff; } .penci-block-vc .penci-border-arrow:before { border-top-color: #ffffff; } .penci_header.penci-header-builder.main-builder-header{}.penci-header-image-logo,.penci-header-text-logo{--pchb-logo-title-fw:bold;--pchb-logo-title-fs:normal;--pchb-logo-slogan-fw:bold;--pchb-logo-slogan-fs:normal;}.pc-logo-desktop.penci-header-image-logo img{max-height:44px;}@media only screen and (max-width: 767px){.penci_navbar_mobile .penci-header-image-logo img{}}.penci_builder_sticky_header_desktop .penci-header-image-logo img{}.penci_navbar_mobile .penci-header-text-logo{--pchb-m-logo-title-fw:bold;--pchb-m-logo-title-fs:normal;--pchb-m-logo-slogan-fw:bold;--pchb-m-logo-slogan-fs:normal;}.penci_navbar_mobile .penci-header-image-logo img{max-height:40px;}.penci_navbar_mobile .sticky-enable .penci-header-image-logo img{}.pb-logo-sidebar-mobile{--pchb-logo-sm-title-fw:bold;--pchb-logo-sm-title-fs:normal;--pchb-logo-sm-slogan-fw:bold;--pchb-logo-sm-slogan-fs:normal;}.pc-builder-element.pb-logo-sidebar-mobile img{max-width:200px;max-height:60px;}.pc-logo-sticky{--pchb-logo-s-title-fw:bold;--pchb-logo-s-title-fs:normal;--pchb-logo-s-slogan-fw:bold;--pchb-logo-s-slogan-fs:normal;}.pc-builder-element.pc-logo-sticky.pc-logo img{max-width:300px;}.pc-builder-element.pc-main-menu{--pchb-main-menu-fs:15px;--pchb-main-menu-fs_l2:13px;--pchb-main-menu-lh:56px;--pchb-main-menu-tt: none;}.pc-builder-element.pc-second-menu{--pchb-second-menu-fw:400;--pchb-second-menu-fs:12px;--pchb-second-menu-lh:20px;--pchb-second-menu-fs_l2:12px;}.pc-builder-element.pc-third-menu{--pchb-third-menu-fs:12px;--pchb-third-menu-fs_l2:12px;}.penci-builder.penci-builder-button.button-1{}.penci-builder.penci-builder-button.button-1:hover{color:#111111;}.penci-builder.penci-builder-button.button-2{}.penci-builder.penci-builder-button.button-2:hover{color:#111111;}.penci-builder.penci-builder-button.button-3{}.penci-builder.penci-builder-button.button-3:hover{}.penci-builder.penci-builder-button.button-mobile-1{}.penci-builder.penci-builder-button.button-mobile-1:hover{}.penci-builder.penci-builder-button.button-2{}.penci-builder.penci-builder-button.button-2:hover{}.penci-builder-mobile-sidebar-nav.penci-menu-hbg{border-width:0;border-style:solid;}.pc-builder-menu.pc-dropdown-menu{--pchb-dd-lv1:12px;--pchb-dd-lv2:12px;}.penci-header-builder .penci-builder-element.penci-data-time-format{margin-top:0px;margin-right: 0px;margin-bottom: 0px;margin-left: 0px;}.penci-header-builder .pc-builder-element.penci-menuhbg-wapper{margin-top:0px;margin-right: 0px;margin-bottom: 0px;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;}.penci-header-builder .pc-builder-element.pc-second-menu{margin-left: 0px;}.penci-header-builder .header-social.penci-builder-element.desktop-social{margin-right: 10px;margin-left: 0px;}.penci-header-builder .penci-builder-element.pc-search-form{}.penci-mobile-midbar{border-bottom-width: 1px;}.penci-desktop-sticky-mid{padding-top: 0px;padding-bottom: 0px;}.pc-builder-element a.penci-menuhbg-toggle{margin-top:0px;margin-right: 0px;margin-bottom: 0px;margin-left: 0px;padding-top: 6px;padding-right: 6px;padding-bottom: 6px;padding-left: 6px;}.pc-builder-element.penci-top-search .search-click{border-style:none}.pc-builder-element.pc-main-menu .navigation ul.menu 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elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-72a23c8" data-id="72a23c8" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-a91ff18 elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading" data-id="a91ff18" data-element_type="widget" data-widget_type="theme-post-title.default"> <div class="elementor-widget-container"> <style>/*! elementor - v3.23.0 - 15-07-2024 */ .elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}</style><h1 class="elementor-heading-title elementor-size-default">When is a Digital 4.0 MES not a Digital 4.0 MES?</h1> </div> </div> <div class="elementor-element elementor-element-77acc1b elementor-widget pcsb-ft-o elementor-widget-penci-single-featured-overlay" data-id="77acc1b" data-element_type="widget" data-widget_type="penci-single-featured-overlay.default"> <div class="elementor-widget-container"> <div class="post-image penci-move-title-above"> <a href="https://middleeast.engineersoutlook.com/wp-content/uploads/2023/05/Nigel-Cryer.jpg" data-rel="penci-gallery-bground-content"><span class="attachment-penci-full-thumb size-penci-full-thumb penci-single-featured-img wp-post-image penci-disable-lazy" style="background-image: url(https://middleeast.engineersoutlook.com/wp-content/uploads/2023/05/Nigel-Cryer.jpg);padding-top: 75.0000%;"></span></a><div class="standard-post-special_wrapper"><div class="penci-fto-ct"><div class="container penci-container-inside penci-breadcrumb single-breadcrumb"><span><span><a href="https://middleeast.engineersoutlook.com/">Home</a></span> » <span class="breadcrumb_last" aria-current="page">When is a Digital 4.0 MES not a Digital 4.0 MES?</span></span></div> <div class="header-standard header-classic single-header"> <div class="penci-standard-cat penci-single-cat "><span class="cat"> <a class="penci-cat-name penci-cat-202" href="https://middleeast.engineersoutlook.com/category/engineersinsights/" rel="category tag">EngineersInsights</a><a class="penci-cat-name penci-cat-170" href="https://middleeast.engineersoutlook.com/category/manufacturing/mes/" rel="category tag">MES</a> </span></div> <h1 class="post-title single-post-title entry-title"><span>When is a Digital 4.0 MES not a Digital 4.0 MES?</span></h1> <div class="penci-hide-tagupdated"> <span class="author-italic author vcard">by <a class="url fn n" href="https://middleeast.engineersoutlook.com/author/nigel/">Nigel Cryer, Global Corporate Quality Audit Head, Sanofi</a></span> <time class="entry-date published" datetime="2023-05-18T06:58:24+00:00">May 18, 2023</time> </div> <div class="post-box-meta-single style-default"> <span class="author-post byline"> <span class="author vcard"> <span class="pcmt-icon ava-icon"><i class="far fa-user"></i></span> written by <a class="author-url url fn n" href="https://middleeast.engineersoutlook.com/author/nigel/"> Nigel Cryer, Global Corporate Quality Audit Head, Sanofi </a> </span> </span> <span class="pctmp-date-post"> <span class="pcmt-icon date-icon"><i class="far fa-clock"></i></span> <time class="entry-date published" datetime="2023-05-18T06:58:24+00:00">May 18, 2023</time></span> </div> </div></div></div> </div> </div> </div> <div class="elementor-element elementor-element-08748c1 elementor-widget pcsb-mct elementor-widget-penci-single-content" data-id="08748c1" data-element_type="widget" data-widget_type="penci-single-content.default"> <div class="elementor-widget-container"> <div class="post-entry blockquote-style-1"> <div class="inner-post-entry entry-content" id="penci-post-entry-inner"> <p><strong>When you can’t show me the data!</strong></p> <p><strong>When your process is not fully controlled!</strong></p> <p><strong>Will these new implementations fully comply with new world data integrity requirements?</strong></p> <p><strong>Imagine this scenario taking place in your board room 2-5 years ago.</strong></p> <div><div class="penci-custom-html-inside-content"><!--div style="text-align: center;"> <a style="display: inline-block; max-width: 728px;" href="https://1.envato.market/YYJ4P" target="_blank"><img loading="lazy" decoding="async" loading="lazy" src="https://soledaddemo.pencidesign.net/wp-content/uploads/2021/08/banner-home.jpg" width="728" height="90" alt="banner"></a> </div>--></div></div><p>The CEO walks into the quarterly strategy meeting with and asks “What is the status of our companies move to a Digital4.0MES system? Because I hear our competitors are way ahead of us.”</p> <p>VP of Computerised Systems assertively answers we are in discussions with vendors and should have a 5 year strategy for roll-out in place in in 12 months time. I will provide an update at the next strategy meeting.</p> <p>What are the likely cost savings? Asks the VP of finance.</p> <p>In between the lines you have to ask what are the motives for the move to Digital4.0MES systems?</p> <p>In my criticality focused and patient centered world the motives would be to have processes in place to allow fully controlled management of the factory to ensure a right 1<sup>st</sup> time all the time production of material of the highest quality knowing that all critical parameters were in trend with the production of the last 30 lots and that the quality of the material produced will have lowest levels of impurities, fully bioburden or sterility controlled. The operators fully aware of all the risks at every step of the process which is fully automated and requires minimum intervention by them and also minimum interventions by maintenance technicians and automation engineers. At the end of manufacture a report listing all critical and process control parameters stating highest-lowest, mean values with any alert or action limits listed. A trend report showing the comparison of the lot data value trends for the last 30 lots. A list of all alarms showing acknowledgements with the investigations listed and confirmed closed.  A list of deviations and OOS investigations showing quality impact and closure dates. A list of change controls impacting the lot. Stability data trends show changes from time 0 to end of shelf life.</p> <p>So have you implemented digital 4.0 MES? When implemented was it heralded in the boardroom room and company media as a massive success. If so congratulations to you.</p> <p>Just one questions do you have all of my worlds’ requirements in place?</p> <p>At a recent conference I asked this question of leading industry experts and the answer was not so positive.</p> <p>I heard of stories:</p> <ul> <li>Where operators still hand fill in batch records, scan them and load them up to the MES system.</li> <li>Where only one CPP will have 100% data collected automatically while capability is available using best available technology to collect all critical or control parameters.</li> <li>Where some control and critical process parameters are not measured by sensors and so no data is collected.</li> <li>Where recipes for Computerised equipment control do not list all changes made and when changes are made without any traceability.</li> <li>Where data from manual gauges is documented every day instead of being continuous.</li> </ul> <p>What should be done?</p> <p>Return to offices and have an assessment of your process, data collection, alarm management, audit trails, data trending and sensors in place. If you identify gaps determine if they are critical or control parameters. Consider procedural mitigation actions to reduce the risks and then consider remediation actions such as upgrading sensor management, data collection, analysis, trending, reporting and your quality assurance systems. Also justify addition of data lakes and analysis tools to enhance compliance of your MES system.</p> <p><strong>Bio:</strong></p> <p style="padding-left: 40px;">Nigel Cryer has over 40years experience in Biotech, Pharmaceutical and API manufacture. He has been involved in QC computer system integration, GLP database management/ statistical analysis, SAP material management systems and GMP process control systems since the 1990’s. He currently works for Sanofi as a Global Corporate Quality auditor and is currently registering his consultancy company “Bluciela Lifesciences” he can be contacted at <a href="mailto:nigel.cryer@yahoo.co.uk">nigel.cryer@yahoo.co.uk</a> or via LinkedIn.</p> <p style="padding-left: 40px;">The opinions expressed in this article are solely those of the author alone and are based on industry common knowledge from the last 40 years and not necessarily those of Sanofi. Sanofi does not guarantee the accuracy or reliability of the information provided. All references to people or positions are entirely fictional added for dramatic impact. No inference is given nor intended to my current nor past employers.</p> <p style="padding-left: 40px;">@2023 Nigel Cryer All rights reserved.</p> <p> </p> <div class="penci-ilrltpost-beaf"> <div class="penci-ilrelated-posts pcilrt-list pcilrt-none pcilrt-col-2"> <div class="pcilrp-heading pcilrph-align-left"> <span>You Might Also Like</span></div> <ul class="pcilrp-content"> <li class="pcilrp-item pcilrp-item-list"> <a href="https://middleeast.engineersoutlook.com/simulation-software-is-the-next-big-tech-trend-shaping-quick-service-restaurant-qsr-4-0-efficiency/">Simulation Software Is the Next Big Tech Trend Shaping Quick-Service Restaurant (QSR) 4.0 Efficiency</a> </li> <li class="pcilrp-item pcilrp-item-list"> <a href="https://middleeast.engineersoutlook.com/fuuzs-new-website-assists-manufacturers-and-distributors-in-locating-technology-solutions-to-improve-industrial-processes/">Fuuz&#8217;s new website assists manufacturers and distributors in locating technology solutions to 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