{"id":10318,"date":"2021-09-20T10:48:11","date_gmt":"2021-09-20T08:48:11","guid":{"rendered":"https:\/\/www.s4bt.it\/assessment-e-remediation-del-sistema-informatico-aziendale-basato-su-as400\/"},"modified":"2026-02-02T09:17:31","modified_gmt":"2026-02-02T08:17:31","slug":"assessment-and-remediation-of-the-company-it-system-based-on-as400","status":"publish","type":"page","link":"https:\/\/www.s4bt.it\/en\/projects\/assessment-and-remediation-of-the-company-it-system-based-on-as400\/","title":{"rendered":"Assessment and Remediation of the Company IT System based on AS400"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"10318\" class=\"elementor elementor-10318 elementor-2548\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6d66befc elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6d66befc\" 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-6e7837f6\" data-id=\"6e7837f6\" 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-45ec5aae elementor-widget elementor-widget-heading\" data-id=\"45ec5aae\" 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\">PROJECTS<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ffdbb4e elementor-widget-divider--separator-type-pattern elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"ffdbb4e\" 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-9dc994b elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"9dc994b\" 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\">Assessment and Remediation of the Company IT System based on AS400<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-54b30af8 elementor-widget elementor-widget-text-editor\" data-id=\"54b30af8\" 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><strong>Client: <\/strong>a leading homeopathic company that for over 60 years has pursued the goal of disseminating and developing alternative medical practices through the production and distribution of quality, state-of-the-art homeopathic products. <\/p>\n<p><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\"><strong>Sector:<\/strong> Homoeopathic<\/span><\/p>\n<p><strong>Objective:<\/strong> to perform a complete diagnostic analysis of the company IT system to make it more compliant with GAMP guidelines and the Annex 11 Regulation.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5f1aa685 elementor-widget elementor-widget-heading\" data-id=\"5f1aa685\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Project<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17064144 elementor-widget elementor-widget-text-editor\" data-id=\"17064144\" 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><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\">Operating in a sector that is particularly attentive to the relevant regulations, the client company needed to carry out a complete diagnosis of the company&#8217;s IT system to make it even more compliant with the GAMP guidelines and Annex 11 regulations. <\/span><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-43c0ab78 elementor-widget elementor-widget-heading\" data-id=\"43c0ab78\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Our contribution<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-57587718 elementor-widget elementor-widget-text-editor\" data-id=\"57587718\" 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 client turned to the specific technical expertise of the <em>S4BT CSV &#8211; Computer System Validation<\/em> &#8211; team.<\/p>\n<p>The project team structured the work in two macro-phases:<\/p>\n<p><strong>1. Assessment:<\/strong><\/p>\n<p>analysis of the management system used by the client company (based on AS400) to make it more robust in implementing the regulations.<\/p>\n<p>The work team therefore:<\/p>\n<ul>\n<li><strong>analysed the existing technical documentation<\/strong> (procedures, validation protocols, etc.).<\/li>\n<li><strong style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size );\">verified the use of the system in the field<\/strong><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\"> by the users (with particular attention to the functionalities in use and the data managed) by interviewing both the reference users for the company areas involved (Logistics, Production, Quality Control, Administration) and the resources dedicated to the management and administration of the system by drafting a final report containing a Risk analysis based on the GxP criticalities managed by the IT system and the actions to be taken.<\/span><\/li>\n<\/ul>\n<p><strong>2. Remediation:<\/strong> revalidation of the computer system used in the management of the client company&#8217;s most important departments:<\/p>\n<ul>\n<li>Logistics<\/li>\n<li>Laboratories<\/li>\n<li>Production laboratory<\/li>\n<li>Accounting<\/li>\n<li>Administration<\/li>\n<\/ul>\n<p>The validation strategy implemented was conceived precisely to improve alignment with <em>CFR 21 part 11<\/em> and <em>Annex 11<\/em> regulations.<\/p>\n<p>The <strong>CSV consultants<\/strong> then drafted and executed the following documents:<\/p>\n<ul>\n<li><strong>User Requirements Specification<\/strong>: with the aim of defining the main user requirements<\/li>\n<li><strong>Validation Master Plan<\/strong>: to define the strategy and activities needed to guarantee with<br \/>documented evidence that the company ERP system used in the iMO plant attains and maintains validation status<\/li>\n<li><strong>Installation Qualification (IQ)<\/strong> proving compliance of system installation with the supplier&#8217;s hardware and software specifications<\/li>\n<li><b>Operational Qualification (OQ)<\/b> providing documentary evidence that the computer system in use in the facility is able to operate in accordance with the user&#8217;s needs for regulatory, administrative, technological, production, laboratory, and logistical purposes.<\/li>\n<li><b>Performance Qualification (PQ)<\/b> providing documentary evidence that the AS\/400 computer system can guarantee compliance in the production environment. <\/li>\n<\/ul>\n<p>Finally, the work team prepared the final report.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1d91d91 elementor-widget elementor-widget-heading\" data-id=\"1d91d91\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Result<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c1fc7e9 elementor-widget elementor-widget-text-editor\" data-id=\"c1fc7e9\" 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 accuracy of the preliminary analysis allowed the client to implement an <strong>effective Remediation<\/strong> realised in a shorter time than expected due to the complexity of the system and the flows managed. S4BT&#8217;s intervention has built the basis for a more efficient and effective system management strategy, facilitating future changes and regular revalidations.<\/p>\n<p>The strategy created by the S4BT professionals is still used by the client. The support of the team thus allowed the client to <b>improve their performance<\/b> and to pass with distinction the subsequent <b>inspections<\/b> by the regulatory bodies regarding the management of the IT system.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-65372b0e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"65372b0e\" 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-5566ed5a\" data-id=\"5566ed5a\" 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-29151294 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"29151294\" 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\">read about other projects<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5599c317 elementor-widget elementor-widget-text-editor\" data-id=\"5599c317\" 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<ul><li><a href=\"https:\/\/www.s4bt.it\/en\/projects\/assessment-csv\/\">Assessment of the control system for filling\/packaging machines<\/a><\/li><li><a href=\"https:\/\/www.s4bt.it\/en\/convalida-delle-utilities-di-stabilimento\/\">Validation of Facility Utilities<\/a><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2b6a6feb elementor-absolute elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"2b6a6feb\" data-element_type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;}\" 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\">\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\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\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-56fddb3c\" data-id=\"56fddb3c\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_gallery&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<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-12fb7de elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"12fb7de\" 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-63832417\" data-id=\"63832417\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_gallery&quot;:[{&quot;id&quot;:10310,&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-a5b48b7 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"a5b48b7\" 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\/\/pragma-wfm\/\">\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\">validation &amp; qualification<\/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-6aa0b02 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6aa0b02\" 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-f8e373f\" data-id=\"f8e373f\" 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-2dca097 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"2dca097\" 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\">CONSULTING SERVICE ACQUIRED BY THE CLIENT COMPANY<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2567c7e elementor-widget elementor-widget-text-editor\" data-id=\"2567c7e\" 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<ul><li><a href=\"https:\/\/www.s4bt.it\/\/home\/attivita-di-consulenza-e-validazione\/computer-system-validation-data-integrity\/\">Computer System Validation<\/a><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-37d2967 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"37d2967\" 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\">REQUEST MORE INFORMATION<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9d0653d elementor-widget elementor-widget-html\" data-id=\"9d0653d\" data-element_type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>@import url(https:\/\/fonts.bunny.net\/css?family=poppins:400,700);<\/style>\n<style>\n#_form_46_{font-size:14px;line-height:1.6;font-family:arial, helvetica, sans-serif;margin:0}#_form_46_ 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for=\"field[22][]\" class=\"_form-label\">\n          <\/legend>\n        <\/div>\n        <input data-autofill=\"false\" type=\"hidden\" id=\"field[22][]\" name=\"field[22][]\" value=\"~|\">\n        <div class=\"_row _checkbox-radio\">\n          <input id=\"field_22I have read the Privacy Statement and I authorize the treatment of my personal data (GDPR May 25, 2018)\" type=\"checkbox\" name=\"field[22][]\" value=\"I have read the Privacy Statement and I authorize the treatment of my personal data (GDPR May 25, 2018)\"   required>\n          <span>\n            <label for=\"field_22I have read the Privacy Statement and I authorize the treatment of my personal data (GDPR May 25, 2018)\">\n              I have read the Privacy Statement and I authorize the treatment of my personal data (GDPR May 25, 2018)*\n            <\/label>\n          <\/span>\n        <\/div>\n      <\/fieldset>\n    <\/div>\n    <div class=\"_form_element _x07624565 _full_width _clear\" >\n      <div 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