{"id":2868,"date":"2021-08-19T11:30:10","date_gmt":"2021-08-19T09:30:10","guid":{"rendered":"http:\/\/www.invpack.com\/documentation\/"},"modified":"2026-11-04T10:19:10","modified_gmt":"2026-11-04T09:19:10","slug":"documentation","status":"publish","type":"page","link":"https:\/\/invpack.com\/fr\/documentation\/","title":{"rendered":"Documentation"},"content":{"rendered":"\t\t
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Documentation<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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INVpack dispose d\u2019une zone charg\u00e9e de g\u00e9n\u00e9rer et de s\u2019assurer que l\u2019\u00e9quipement comprend la prochaine documentation technique :<\/p>\n

    \n
  • Dessins de la machine: plan de bobine, mise en page, dessins \u00e9lectriques et pneumatiques, P&ID<\/li>\n
  • Liste des composants \u00e9lectriques et pneumatiques<\/li>\n
  • Nomenclature (pi\u00e8ces de rechange, remplacements et lubrifiant recommand\u00e9)<\/li>\n
  • Donn\u00e9es techniques et fournitures n\u00e9cessaires<\/li>\n
  • Manuel d\u2019installation<\/li>\n
  • Mode d\u2019emploi et mode d\u2019emploi<\/li>\n
  • Manuel d\u2019entretien et de nettoyage<\/li>\n
  • Copie de s\u00e9curit\u00e9 du programme (sauvegarde\/restauration)<\/li>\n
  • Certificat de Conformit\u00e9 Europ\u00e9en<\/li>\n<\/ul>\n

    Et assurez-vous que la machine est conforme aux r\u00e9glementations de s\u00e9curit\u00e9 (RM UE 2023\/1230, directive de compatibilit\u00e9 \u00e9lectromagn\u00e9tique 2004\/108\/CE et directive de r\u00e9glementation de basse tension 2008\/95\/CE).<\/p>\n

    En plus de la documentation requise pour l\u2019utilisation, l\u2019exploitation et la maintenance, le client peut \u00e9galement demander les services suivants:<\/p>\n

    Orient\u00e9 vers le secteur pharmaceutique, conform\u00e9ment aux GMP annexes 11 & 15, US 21 CFR Part 11 et GAMP 5, INVpack propose un package de qualification de machine qui int\u00e8gre:<\/p>\n

      \n
    • Validation Sch\u00e9ma Directeur (VMP)<\/li>\n
    • Analyse des risques selon ICH Q9 (RA)<\/li>\n
    • Sp\u00e9cifications fonctionnelles (FS)<\/li>\n
    • Sp\u00e9cifications de conception et qualification (DS\/DQ)<\/li>\n
    • Sp\u00e9cifications mat\u00e9rielles et logicielles (HSS)<\/li>\n
    • Qualification Hardware & Software (HSQ)<\/li>\n
    • Test d\u2019acceptation en usine (FAT)<\/li>\n
    • Test d\u2019acceptation sur site (SAT)<\/li>\n
    • Qualification d\u2019installation (QI)<\/li>\n
    • Qualification Op\u00e9rationnelle (QO)<\/li>\n<\/ul>\n

      Focus sur le secteur alimentaire et en accord avec la norme ISO 22.000, pr\u00e9sente l\u2019analyse des risques et le contr\u00f4le des points critiques (HACCP) se concentre sur les \u00e9quipements et les certificats de mat\u00e9riaux en contact avec le produit (en accord avec CE 1935\/2004 & CE 10\/2011).<\/p>\n

      En ce qui concerne les termes de s\u00e9curit\u00e9 de l\u2019utilisateur, l\u2019analyse du mode de d\u00e9faillance de la machine et de ses effets (FMEA) et en termes de s\u00e9curit\u00e9 contre les explosions, l\u2019\u00e9tude d\u2019\u00e9valuation des risques d\u2019explosion de l\u2019\u00e9quipement (ATEX) est \u00e9galement fournie.<\/p>\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<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

      INVpack dispose d\u2019une zone charg\u00e9e de g\u00e9n\u00e9rer et de s\u2019assurer que l\u2019\u00e9quipement comprend la prochaine documentation technique : Dessins de la machine: plan de bobine, mise en page, dessins \u00e9lectriques et pneumatiques, P&ID Liste des composants \u00e9lectriques et pneumatiques Nomenclature (pi\u00e8ces de rechange, remplacements et lubrifiant recommand\u00e9) Donn\u00e9es techniques et fournitures n\u00e9cessaires Manuel d\u2019installation Mode […]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":0,"menu_order":31,"comment_status":"closed","ping_status":"closed","template":"","meta":{"content-type":"","footnotes":""},"class_list":["post-2868","page","type-page","status-publish","hentry"],"yoast_head":"\nDocumentation machines INVpack - INVpack<\/title>\n<meta name=\"description\" content=\"Toutes les machines INVpack sont livr\u00e9es avec la documentation requise selon chaque cas.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/invpack.com\/fr\/documentation\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Documentation machines INVpack - 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