{"id":38975,"date":"2026-08-21T17:46:28","date_gmt":"2026-08-21T17:46:28","guid":{"rendered":"https:\/\/orise.com\/?page_id=38975"},"modified":"2026-09-02T18:26:23","modified_gmt":"2026-09-02T18:26:23","slug":"checklist-conformita-csv","status":"publish","type":"page","link":"https:\/\/orise.com\/it\/checklist-conformita-csv\/","title":{"rendered":"CSV Compliance Checklist"},"content":{"rendered":"<div id=\"pageheader-block_6b480525b4fd2039495f80367e7a7eca\" class=\"content-row content-row-pageheader background_blue pageheader\">\n        <div class=\"contentPart-fixed\">\n        <div class=\"contentPart-inner\">\n            <div class=\"contentPart-text width-100\">\n                <h1>\n                                        Compila il modulo e scarica la CSV Compliance Checklist per Pharma &amp; Biotech                                    <\/h1>\n                                                            <\/div>\n        <\/div>\n    <\/div>\n    <div class=\"slidedown-button editor-hide\">\n        <span class=\"slidedown-label\"><\/span>\n        <img decoding=\"async\" src=\"https:\/\/orise.com\/wp-content\/themes\/ats-orise\/img\/doubble-arrow-down.svg\" alt=\"\"\n            class=\"slidedown-icon\">\n    <\/div>\n<\/div>\n\n\n    <div id=\"contactform-block_1a6dfb70a6f109c3330500c81597b4c8\" class=\"content-row content-row-contactform  background_darken contactform\">\n        <div class=\"contentPart-inner\">\n\n            <div class=\"contentPart-text width-100\">\n                            <\/div>\n\n            <div class=\"contactform-wrapper trans\">\n                                    <iframe src=\"https:\/\/go.orise.com\/l\/651873\/2026-08-20\/h8qytd\" class=\"form-iframe form-iframe-contactform\" data-cookieconsent=\"marketing\"><\/iframe>\n                            <\/div>\n\n        <\/div>\n    <\/div>\n\n\n    <div id=\"singletext-block_c844de5a7a21fd9eab500a6a174ccc0e\" class=\"content-row content-row-singletext bg-base   singletext\">\n        <div class=\"contentPart-inner\">\n            <div class=\"contentPart-text width-100\">\n                                <div class=\"contentPart-textbox textInput trans\">\n                    <table>\n<tbody>\n<tr>\n<td><strong>43 controlli su GAMP 5, 21 CFR Part 11, EU GMP Annex 11 e data integrity PIC\/S, pi\u00f9 una verifica di preparazione in 8 punti per la bozza 2025 dell&#8217;Annex 11 e il nuovo Annex 22 sull&#8217;IA.<\/strong><\/p>\n<p>&nbsp;<\/td>\n<\/tr>\n<tr>\n<td><strong>La maggior parte dei sistemi GxP computerizzati supera i propri test di convalida. Ci\u00f2 che mette in difficolt\u00e0 i team durante un&#8217;ispezione \u00e8 l&#8217;implementazione: interfacce lasciate fuori dall&#8217;ambito di convalida, audit trail che non hanno mai registrato il valore precedente, revisioni degli accessi mai pianificate, un ripristino mai testato.<\/strong><\/p>\n<p>&nbsp;<\/td>\n<\/tr>\n<tr>\n<td><strong>GAMP 5\u00a0 \u00a0\u00b7\u00a0 \u00a0 21 CFR PART 11\u00a0 \u00a0\u00b7\u00a0 \u00a0EU ANNEX 11\u00a0 \u00a0\u00b7\u00a0 \u00a0 ICH Q9(R1)\u00a0 \u00a0\u00b7\u00a0 \u00a0PIC\/S PI 041-1<\/strong><\/p>\n<p>&nbsp;<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n                <\/div>\n            <\/div>\n        <\/div>\n    <\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":617,"featured_media":36868,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_cr_original_post":"","_cr_replace_post_id":"","_cr_replacing_post_id":"","footnotes":""},"class_list":["post-38975","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.5 (Yoast SEO v28.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>CSV Compliance Checklist | Orise<\/title>\n<meta name=\"description\" content=\"43 verifiche tra GAMP 5, 21 CFR Part 11, EU GMP Annex 11 e integrit\u00e0 dei dati PIC\/S \u2014 oltre a un controllo di idoneit\u00e0 in 8 punti per la bozza dell&#039;Annex 11 del 2025 e il nuovo Annex 22 sull&#039;IA.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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