{"id":38979,"date":"2026-08-21T17:46:28","date_gmt":"2026-08-21T17:46:28","guid":{"rendered":"https:\/\/orise.com\/?page_id=38979"},"modified":"2026-09-03T15:18:07","modified_gmt":"2026-09-03T15:18:07","slug":"csv-nalevingschecklist","status":"publish","type":"page","link":"https:\/\/orise.com\/nl\/csv-nalevingschecklist\/","title":{"rendered":"CSV Compliance Checklist"},"content":{"rendered":"<div id=\"pageheader-block_3ff40711622678844f2d118bbb5306d1\" 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                                        Vul het formulier in en download de CSV Compliance Checklist voor 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_e1a24bff1a13a081a110f2895029143b\" class=\"content-row content-row-contactform  background_darken contactform\">\n        <div class=\"contentPart-inner\">\n\n            <div class=\"contentPart-text width-100\">\n                                    <h2 class=\"text-blue content-row-headline trans\">\n                        Vul het formulier in en download de CSV Compliance Checklist voor Pharma &amp; Biotech                    <\/h2>\n                            <\/div>\n\n            <div class=\"contactform-wrapper trans\">\n                                    <iframe src=\"https:\/\/go.orise.com\/l\/651873\/2026-08-20\/h8qyt3\" class=\"form-iframe form-iframe-contactform\" data-cookieconsent=\"marketing\"><\/iframe>\n                            <\/div>\n\n        <\/div>\n    <\/div>\n\n\n    <div id=\"singletext-block_095b543bfa74de5f3f8def030fdd9cd0\" 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 controlepunten op basis van GAMP 5, 21 CFR Part 11, EU GMP Annex 11 en PIC\/S-gegevensintegriteit, plus een 8-punts gereedheidscontrole voor de Annex 11-conceptversie van 2025 en de nieuwe Annex 22 over AI.<\/strong><\/p>\n<p>&nbsp;<\/td>\n<\/tr>\n<tr>\n<td><strong>De meeste geautomatiseerde GxP-systemen doorstaan hun eigen validatietests. Wat teams tijdens een inspectie in de problemen brengt, is de implementatie: interfaces die buiten de validatiescope bleven, audit trails die de vorige waarde nooit hebben vastgelegd, toegangsreviews die nooit werden ingepland, een restore die nooit is getest.<\/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><\/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":36866,"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-38979","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 v28.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>CSV Compliance Checklist | Orise<\/title>\n<meta name=\"description\" content=\"43 controles over GAMP 5, 21 CFR Part 11, EU GMP Annex 11 en PIC\/S dataintegriteit \u2014 plus een readiness check van 8 punten voor de concept-Annex 11 van 2025 en de nieuwe Annex 22 over AI.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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