{"id":12776,"date":"2021-10-11T12:17:00","date_gmt":"2021-10-11T12:17:00","guid":{"rendered":"https:\/\/expleo.com\/global\/fr\/?post_type=case-studies&p=12776"},"modified":"2024-02-19T17:22:48","modified_gmt":"2024-02-19T17:22:48","slug":"validation-du-si-pour-la-gestion-des-batiments-utilites-et-equipements","status":"publish","type":"case-studies","link":"https:\/\/expleo.com\/global\/fr\/cas-clients\/validation-du-si-pour-la-gestion-des-batiments-utilites-et-equipements\/","title":{"rendered":"Validation du SI pour la gestion des “B\u00e2timents, utilit\u00e9s et \u00e9quipements”"},"content":{"rendered":"\t\t
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Expleo s\u2019assure que les syst\u00e8mes informatiques de l\u2019un des leaders mondiaux de l\u2019industrie pharmaceutique pour la gestion des \u00ab\u00a0B\u00e2timents, utilit\u00e9s et \u00e9quipements\u00a0\u00bb, d\u00e9nomm\u00e9 FAM en anglais (Facility & Asset Management) et d\u2019autres syst\u00e8mes soient valides et coh\u00e9rents pour se conformer aux r\u00e9glementations sanitaires mondiales.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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D\u00e9fi & contexte\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Depuis 2008, Expleo travaille avec ce client, l\u2019un des principaux groupes pharmaceutiques du monde, sur divers projets de syst\u00e8mes d\u2019information. En 2021, le client nous a demand\u00e9 d\u2019apporter l\u2019expertise en validation pour garantir que leurs syst\u00e8mes informatiques de gestion des FAM et d\u2019autres syst\u00e8mes soient valides et restent conformes aux r\u00e9glementations de la FDA (Food & Drug Administration) et d\u2019autres autorit\u00e9s sanitaires \u00e0 travers tous ses sites dans le monde. Le programme mondial FAM a d\u00e9but\u00e9 dans l\u2019installation principale de ce client en Allemagne et sera d\u00e9ploy\u00e9 mondialement sur environ 20 sites du groupe avec plusieurs installations \u00e0 maintenir.<\/p>

Avec des \u00e9carts g\u00e9ographiques du fait de diff\u00e9rentes r\u00e9glementations (en fonction des autorit\u00e9s sanitaires locales), notre client souhaitait assurer la transformation mondiale des processus commerciaux et des donn\u00e9es des syst\u00e8mes locaux pour les regrouper en un seul syst\u00e8me ERP mondial, avec une migration correcte des donn\u00e9es des syst\u00e8mes sources vers les syst\u00e8mes cibles.<\/p>

Il \u00e9tait aussi essentiel de sensibiliser tous les membres du projet \u00e0 l\u2019environnement r\u00e9glement\u00e9 de s\u00e9curit\u00e9 des patients, ainsi que de s\u2019assurer que le syst\u00e8me num\u00e9rique de gestion des \u00ab B\u00e2timents, utilit\u00e9s et \u00e9quipements \u00bb soit conforme et n\u2019\u00e9choue pas aux inspections ou aux audits externes par les autorit\u00e9s sanitaires et les clients.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Solution<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Les diverses comp\u00e9tences et l\u2019exp\u00e9rience d\u2019Expleo dans la gestion de projets complexes, ainsi que son utilisation de consultants externes et de sous-traitants enti\u00e8rement int\u00e9gr\u00e9s au sein de diverses \u00e9quipes et organisations de notre client pour r\u00e9pondre aux exigences du projet, permettent d\u2019offrir une gamme compl\u00e8te de services, de la validation \u00e0 la coordination des tests, du contr\u00f4le qualit\u00e9, de l\u2019expertise de migration des donn\u00e9es, de l\u2019\u00e9valuation des risques, des revues de documentation (pour URS \/ FS \/ TC \/ SOP), etc. En tant qu\u2019experts en validation de syst\u00e8mes informatis\u00e9s (CSV), nous fournissons des conseils pour la validation de logiciels selon les normes pharmaceutiques (GxP, GAMP5, FDA).<\/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

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\r\n R\u00e9sultats <\/h2>\r\n
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La num\u00e9risation et la centralisation de la gestion des \u00ab B\u00e2timents, utilit\u00e9s et \u00e9quipements \u00bb permettent de mettre en oeuvre davantage de processus et de syst\u00e8mes ainsi que de r\u00e9duire les flux de travail sur papier. La connaissance approfondie d\u2019Expleo des processus internes du client dans le d\u00e9veloppement de logiciels au fil des ann\u00e9es se traduit par une prestation de service uniforme et de cr\u00e9ation de documents avec une vraie continuit\u00e9 de service et de qualit\u00e9 d\u00e9livr\u00e9s. Nos responsables de validation s\u2019assurent que les syst\u00e8mes informatis\u00e9s sont valid\u00e9s dans les d\u00e9lais et dans les limites du budget.<\/p>

\u00a0<\/p><\/span> <\/div>\r\n <\/div>\r\n\r\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"Laboratory\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tLire le cas client complet<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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
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\n\t\t\t\tJe travaille dans l\u2019informatique depuis mes d\u00e9buts en tant que D\u00e9veloppeur, Testeur et Manager dont pr\u00e8s de 27 ans dans l\u2019industrie pharmaceutique. Mettre ma connaissance au service de ce client est tr\u00e8s stimulant et enrichissant. Le client est satisfait du travail que mon \u00e9quipe et moi produisons, et apr\u00e8s plusieurs ann\u00e9es \u00e0 travailler pour eux, il y a de bonnes opportunit\u00e9s de prolonger le contrat.\n\n\t\t\t<\/p>\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\tThomas Heimsath, Responsable Qualit\u00e9, Expleo<\/cite>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/blockquote>\n\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
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\r\n Conseils en transformation <\/strong> <\/p>\r\n \r\n

\r\n Gestion de projet (PMO)<\/span> <\/h2>\r\n
\r\n Les \u00e9quipes PMO (gestion de projet) d\u2019Expleo pilotent et facilitent l\u2019\u00e9laboration et l\u2019ex\u00e9cution de processus tout au long de la cha\u00eene de valeur, de la conception au service client.\n\n\n<\/span> <\/div>\r\n \r\n
\r\n \r\n EN SAVOIR PLUS <\/a>\r\n <\/div>\r\n\r\n <\/div>\r\n\r\n \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":"

Expleo s\u2019assure que les syst\u00e8mes informatiques de l\u2019un des leaders mondiaux de l\u2019industrie pharmaceutique pour la gestion des \u00ab\u00a0B\u00e2timents, utilit\u00e9s et \u00e9quipements\u00a0\u00bb soient valides et coh\u00e9rents pour se conformer aux r\u00e9glementations sanitaires mondiales.<\/p>\n","protected":false},"featured_media":12748,"template":"","meta":{"_oasis_is_in_workflow":0,"_oasis_original":0,"_oasis_task_priority":"","service-grey-banner":"false","service-grey-banner-link":"","footnotes":""},"case-study-single-templates":[],"topic":[124,129,184,125],"industry-taxonomy":[135],"country":[91,116],"service":[198,187,69,191],"class_list":["post-12776","case-studies","type-case-studies","status-publish","has-post-thumbnail","hentry","topic-quality-assurance-and-software-development","topic-compliance-and-regulation","topic-data-science-and-cybersecurity","topic-transformation-numerique","industry-taxonomy-sciences-de-la-vie","country-france","country-global","service-transformation-entreprise","service-conseils-en-transformation","service-qa-qe-des-logiciels-alimentes-par-lia","service-qualite-and-tests"],"yoast_head":"\nExpleo | SI dans l'industrie pharmaceutique<\/title>\n<meta name=\"description\" content=\"Expleo valide les syst\u00e8mes informatiques pour la num\u00e9risation des b\u00e2timents, utilit\u00e9s et \u00e9quipements (FAM). D\u00e9couvrir plus.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/expleo.com\/global\/fr\/cas-clients\/validation-du-si-pour-la-gestion-des-batiments-utilites-et-equipements\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Validation du SI pour la gestion des "B\u00e2timents, utilit\u00e9s et \u00e9quipements"\" \/>\n<meta property=\"og:description\" content=\"Expleo valide les syst\u00e8mes informatiques pour la num\u00e9risation des b\u00e2timents, utilit\u00e9s et \u00e9quipements (FAM). 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