{"id":3762,"date":"2021-07-13T18:50:36","date_gmt":"2021-07-13T16:50:36","guid":{"rendered":"https:\/\/www.universalmedica.com\/?p=3762"},"modified":"2021-07-13T18:50:36","modified_gmt":"2021-07-13T16:50:36","slug":"points-forts-et-limites-de-laudit-de-pharmacovigilance-a-distance","status":"publish","type":"post","link":"https:\/\/www.universalmedica.com\/fr\/points-forts-et-limites-de-laudit-de-pharmacovigilance-a-distance\/","title":{"rendered":"Points forts et limites de l\u2019audit de pharmacovigilance \u00e0 distance"},"content":{"rendered":"<p>L\u2019\u00e9mergence du COVID-19 ainsi que les cons\u00e9quences \u00e9conomiques et les restrictions de d\u00e9placement que cette pand\u00e9mie a engendr\u00e9es ont conduit les entreprises \u00e0 revoir leurs modalit\u00e9s d\u2019audit. L\u2019audit \u00e0 distance s\u2019est alors mis en place de fa\u00e7on exponentielle mais quels en sont les points forts et ses limites\u00a0?<\/p>\n<p><strong>Points forts :<\/strong><\/p>\n<ul>\n<li>Maintenir la planification des audits (internes, prestataires) en n\u2019importe quelles circonstances (pand\u00e9mie ou autres \u00e9tats de catastrophes\u2026), plus de flexibilit\u00e9<\/li>\n<li>P\u00e9rim\u00e8tre de l\u2019audit plus \u00e9largi si besoin (incluant d\u2019autres sites du groupe\u2026)<\/li>\n<li>Le partage et l\u2019acc\u00e8s de la documentation sont facilit\u00e9s<\/li>\n<li>Diminution des co\u00fbts\/temps de d\u00e9placement pour les auditeurs<\/li>\n<li>Facilit\u00e9 \u00e0 faire participer plus d\u2019intervenants (experts\u2026)<\/li>\n<li>R\u00e9duction de notre empreinte \u00e9cologique<\/li>\n<li>Plus d\u2019espaces bureau disponibles au sein de l\u2019entreprise<\/li>\n<\/ul>\n<p><strong>Limites :<\/strong><\/p>\n<ul>\n<li>Pr\u00e9paration plus longue si SMQ du laboratoire au format papier<\/li>\n<li>D\u2019\u00e9ventuelles perturbations relatives \u00e0 la connexion (son, wifi\u2026) \u00e0 ne pas n\u00e9gliger<\/li>\n<li>Impossibilit\u00e9 de visualiser des pi\u00e8ces strat\u00e9giques (salle serveurs\u2026)<\/li>\n<li>S\u00e9curit\u00e9 de l\u2019information non contr\u00f4l\u00e9e (ex.: enregistrement vid\u00e9o ou audio)<\/li>\n<li>Echange relationnel avec les audit\u00e9s moins ais\u00e9<\/li>\n<\/ul>\n<p>En conclusion, l\u2019audit \u00e0 distance repr\u00e9sente une opportunit\u00e9 compl\u00e9mentaire \u00e9vidente \u00e0 l\u2019audit sur site. N\u00e9anmoins il est important d\u2019avoir une strat\u00e9gie bien claire et d\u00e9finie, une infrastructure appropri\u00e9e incluant des mesures techniques et organisationnelles adapt\u00e9es \u00e0 ce type d\u2019audit.<\/p>\n<p><img decoding=\"async\" class=\"alignnone  wp-image-3753\" src=\"https:\/\/www.universalmedica.com\/wp-content\/uploads\/2021\/07\/LINKEDIN-11-300x300.jpg\" alt=\"\" width=\"136\" height=\"136\" srcset=\"https:\/\/www.universalmedica.com\/wp-content\/uploads\/2021\/07\/LINKEDIN-11-300x300.jpg 300w, https:\/\/www.universalmedica.com\/wp-content\/uploads\/2021\/07\/LINKEDIN-11-150x150.jpg 150w, https:\/\/www.universalmedica.com\/wp-content\/uploads\/2021\/07\/LINKEDIN-11.jpg 600w\" sizes=\"(max-width: 136px) 100vw, 136px\" \/><\/p>\n<p><strong>Anne-Marie LIBERATORE, PhD<\/strong><\/p>\n<p>Responsible d\u2019Assurance Qualit\u00e9, Universal Medica Group<\/p>\n<p><strong>Sur l\u2019auteur :<\/strong><\/p>\n<p>Anne-Marie LIBERATORE, PhD est Responsable d\u2019Assurance Qualit\u00e9 d\u2019Universal Medica Group. Avec un long parcours dans l\u2019industrie pharmaceutique, Anne-Marie est aussi auditrice externe en qualit\u00e9 pour l\u2019industrie pharmaceutique, les entreprises sp\u00e9cialis\u00e9es en dispositifs m\u00e9dicaux et autres Biotechs.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>L\u2019\u00e9mergence du COVID-19 ainsi que les cons\u00e9quences \u00e9conomiques et les restrictions de d\u00e9placement que cette pand\u00e9mie a engendr\u00e9es ont conduit les entreprises \u00e0 revoir leurs modalit\u00e9s d\u2019audit. L\u2019audit \u00e0 distance s\u2019est alors mis en place de fa\u00e7on exponentielle mais quels en sont les points forts et ses limites\u00a0? Points forts : Maintenir la planification des [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":3755,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[135,134],"tags":[],"class_list":["post-3762","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-compliance-2","category-pharmacovigilance"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Points forts et limites de l\u2019audit de pharmacovigilance \u00e0 distance - Universal Medica<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.universalmedica.com\/fr\/points-forts-et-limites-de-laudit-de-pharmacovigilance-a-distance\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Points forts et limites de l\u2019audit de pharmacovigilance \u00e0 distance - Universal Medica\" \/>\n<meta property=\"og:description\" content=\"L\u2019\u00e9mergence du COVID-19 ainsi que les cons\u00e9quences \u00e9conomiques et les restrictions de d\u00e9placement que cette pand\u00e9mie a engendr\u00e9es ont conduit les entreprises \u00e0 revoir leurs modalit\u00e9s d\u2019audit. 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