{"id":4312,"date":"2026-04-16T16:11:04","date_gmt":"2026-04-16T14:11:04","guid":{"rendered":"https:\/\/ellistat.com\/?p=4312"},"modified":"2026-04-16T16:11:11","modified_gmt":"2026-04-16T14:11:11","slug":"repondre-aux-exigences-iso13485","status":"publish","type":"post","link":"https:\/\/ellistat.com\/en\/repondre-aux-exigences-iso13485\/","title":{"rendered":"Meeting ISO 13485 requirements"},"content":{"rendered":"

Dans les secteurs r\u00e9glement\u00e9s, la pr\u00e9cision des mesures influence directement la conformit\u00e9 aux normes telles que l\u2019ISO 13485\u00a0en Europe et le CFR 21\u00a0Part 11\u00a0aux \u00c9tats-Unis. Ellistat met \u00e0 jour sa Suite Qualit\u00e9 pour automatiser la tra\u00e7abilit\u00e9 des mesures et r\u00e9pondre aux exigences r\u00e9glementaires des secteurs m\u00e9dical et pharmaceutique.<\/p>\n\n\n\n

Garantir l\u2019int\u00e9grit\u00e9 et la tra\u00e7abilit\u00e9 des donn\u00e9es de mesure constitue une exigence centrale dans la fabrication m\u00e9dicale et pharmaceutique, o\u00f9 la conformit\u00e9 et la s\u00e9curit\u00e9 des produits reposent sur des processus de contr\u00f4le qualit\u00e9 fiables. Dans ce contexte, Ellistat a introduit une \u00e9volution de sa Suite Qualit\u00e9 afin d\u2019automatiser l\u2019enregistrement des donn\u00e9es et de renforcer leur tra\u00e7abilit\u00e9 \u00e0 long terme.<\/p>\n\n\n\n

Les donn\u00e9es de mesure au c\u0153ur de la conformit\u00e9 r\u00e9glementaire<\/strong><\/h2>\n\n\n\n

Dans les secteurs r\u00e9glement\u00e9s, la pr\u00e9cision des mesures influence directement la conformit\u00e9 aux normes telles que l\u2019ISO 13485\u00a0en Europe et le CFR 21\u00a0Part 11\u00a0aux \u00c9tats-Unis. Ces r\u00e9f\u00e9rentiels imposent des donn\u00e9es tra\u00e7ables et v\u00e9rifiables pour d\u00e9montrer la conformit\u00e9 des produits et la fiabilit\u00e9 des processus.<\/p>\n\n\n\n

Des donn\u00e9es de mesure fiables permettent de d\u00e9tecter rapidement les \u00e9carts et de mettre en \u0153uvre des actions correctives, r\u00e9duisant ainsi les risques de production non conforme. Avec la digitalisation des environnements industriels, la collecte de donn\u00e9es en temps r\u00e9el am\u00e9liore la r\u00e9activit\u00e9 et soutient l\u2019am\u00e9lioration continue des processus au sein de la cha\u00eene d\u2019approvisionnement num\u00e9rique.<\/p>\n\n\n\n

Enregistrement automatis\u00e9 des donn\u00e9es sans intervention manuelle<\/strong><\/h2>\n\n\n\n

La Suite Qualit\u00e9 mise \u00e0 jour int\u00e8gre une fonction d\u2019enregistrement automatique des donn\u00e9es de mesure, supprimant toute saisie manuelle. Chaque mesure est directement enregistr\u00e9e dans le syst\u00e8me et associ\u00e9e \u00e0 des informations contextuelles telles que le num\u00e9ro de s\u00e9rie, la date et l\u2019identifiant op\u00e9rateur.<\/p>\n\n\n\n

Cette fonctionnalit\u00e9 s\u2019applique aux modules IQC<\/a> (Incoming Quality Control) et SPC<\/a> (Statistical Process Control), permettant de centraliser les donn\u00e9es issues des contr\u00f4les fournisseurs, des op\u00e9rations en cours et des validations finales. En emp\u00eachant toute modification manuelle, le syst\u00e8me r\u00e9duit les risques de manipulation des donn\u00e9es et am\u00e9liore leur fiabilit\u00e9.<\/p>\n\n\n

\n
\"Laboratory<\/figure>\n<\/div>\n\n\n

Int\u00e9gration avec les \u00e9quipements de mesure<\/strong><\/h2>\n\n\n\n

La solution prend en charge les \u00e9quipements capables de g\u00e9n\u00e9rer des fichiers num\u00e9riques, facilitant leur int\u00e9gration dans les flux de gestion de la qualit\u00e9. Pour certains syst\u00e8mes sp\u00e9cifiques, notamment ceux de Zeiss<\/a> et le syst\u00e8me Metrios<\/a>, l\u2019enregistrement direct dans le programme de mesure est impos\u00e9, avec archivage obligatoire des donn\u00e9es.<\/p>\n\n\n\n

Cette approche garantit que chaque mesure r\u00e9alis\u00e9e est automatiquement enregistr\u00e9e et tra\u00e7able, r\u00e9pondant ainsi aux exigences d\u2019audit et de transparence des processus.<\/p>\n\n\n\n

Tra\u00e7abilit\u00e9 \u00e0 long terme et pr\u00e9paration aux audits<\/strong><\/h2>\n\n\n\n

Le syst\u00e8me permet de conserver et de tracer les donn\u00e9es de mesure sur de longues p\u00e9riodes, jusqu\u2019\u00e0 dix ans, conform\u00e9ment aux exigences r\u00e9glementaires des secteurs m\u00e9dical et pharmaceutique.<\/p>\n\n\n\n

Le suivi complet du cycle de vie des donn\u00e9es facilite les audits en permettant un acc\u00e8s rapide aux historiques et en assurant la reconstitution des op\u00e9rations si n\u00e9cessaire.<\/p>\n\n\n\n

Renforcement de la s\u00e9curit\u00e9 des processus qualit\u00e9<\/strong><\/h2>\n\n\n\n

La solution int\u00e8gre des signatures \u00e9lectroniques dans les modules IQC<\/a>, SPC<\/a> and APC<\/a>, permettant de valider les actions de mani\u00e8re s\u00e9curis\u00e9e. Toutes les modifications effectu\u00e9es dans le syst\u00e8me sont enregistr\u00e9es, assurant une tra\u00e7abilit\u00e9 compl\u00e8te des \u00e9v\u00e9nements.<\/p>\n\n\n\n

Les fonctions de tri, de recherche et d\u2019\u00e9dition facilitent l\u2019exploitation des donn\u00e9es collect\u00e9es et contribuent \u00e0 une gestion plus efficace des processus qualit\u00e9.<\/p>\n\n\n\n

Une solution fond\u00e9e sur des m\u00e9thodes \u00e9prouv\u00e9es<\/strong><\/h2>\n\n\n\n

La Suite Qualit\u00e9 repose sur plus de dix ans de d\u00e9veloppement et s\u2019appuie sur des m\u00e9thodologies telles que la ma\u00eetrise statistique des proc\u00e9d\u00e9s, les plans d\u2019exp\u00e9riences et le Six Sigma.<\/p>\n\n\n\n

En combinant automatisation, tra\u00e7abilit\u00e9 et conformit\u00e9, la solution permet aux industriels de maintenir des standards de qualit\u00e9 \u00e9lev\u00e9s tout en r\u00e9pondant aux exigences croissantes des environnements r\u00e9glement\u00e9s.<\/p>","protected":false},"excerpt":{"rendered":"

Dans les secteurs r\u00e9glement\u00e9s, la pr\u00e9cision des mesures influence directement la conformit\u00e9 aux normes telles que l\u2019ISO 13485\u00a0en Europe et le CFR 21\u00a0Part 11\u00a0aux \u00c9tats-Unis. Ellistat met \u00e0 jour sa Suite Qualit\u00e9 pour automatiser la tra\u00e7abilit\u00e9 des mesures et r\u00e9pondre aux exigences r\u00e9glementaires des secteurs m\u00e9dical et pharmaceutique. Garantir l\u2019int\u00e9grit\u00e9 et la tra\u00e7abilit\u00e9 des donn\u00e9es […]<\/p>\n","protected":false},"author":4,"featured_media":3554,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[6,4],"tags":[],"class_list":["post-4312","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-iqc","category-spc"],"acf":[],"yoast_head":"\nR\u00e9pondre aux exigences de l'ISO 13485 - Ellistat<\/title>\n<meta name=\"description\" content=\"Automatisez la tra\u00e7abilit\u00e9 de vos mesures avec notre Suite Qualit\u00e9. 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