{"id":28858,"date":"2024-09-11T14:27:34","date_gmt":"2024-09-11T18:27:34","guid":{"rendered":"https:\/\/staging.systech.ssdev.ca\/case-studies\/implementing-serialization-successfully-takeda-case-study\/"},"modified":"2025-06-30T14:50:48","modified_gmt":"2025-06-30T18:50:48","slug":"virtual-manufacturer-unitrace-compliance-exceptions-management-rework","status":"publish","type":"page","link":"https:\/\/staging.systech.ssdev.ca\/fr\/case-studies\/virtual-manufacturer-unitrace-compliance-exceptions-management-rework\/","title":{"rendered":"\u00c9tude de cas : Le fabricant virtuel minimise le risque de retards d'exp\u00e9dition gr\u00e2ce \u00e0 Systech UniTrace\u00ae pour la conformit\u00e9, la gestion des exceptions et la reprise."},"content":{"rendered":"
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Accueil<\/a><\/span><\/span><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\u00c9tude de cas - V<\/span>Un fabricant virtuel minimise le risque de retards d'exp\u00e9dition gr\u00e2ce \u00e0 Systech UniTrace\u00ae pour la conformit\u00e9, la gestion des exceptions et la reprise des travaux. <\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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“Systech a \u00e9t\u00e9 le choix \u00e9vident pour nous parce qu'ils ont offert une approche plus personnalis\u00e9e pour d\u00e9ployer une solution de s\u00e9rialisation, ce qui \u00e9tait essentiel pour nous en tant que petite entreprise.<\/span><\/span>.”<\/i><\/p>

- Amanda <\/span>Samojedny<\/span>,<\/span> Vice-pr\u00e9sident des op\u00e9rations,<\/span><\/span>\u00a0Amici Pharmaceuticals<\/span><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Client<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Amici Pharmaceuticals<\/a> est une soci\u00e9t\u00e9 bas\u00e9e aux \u00c9tats-Unis fabricant virtuel<\/a> est une soci\u00e9t\u00e9 de produits pharmaceutiques g\u00e9n\u00e9riques fond\u00e9e en 2014. L'entreprise commercialise 10 familles de produits, dont des produits ophtalmiques, des produits solides oraux et des produits liquides oraux, en travaillant avec des partenaires nationaux et internationaux pour fournir des produits de prescription abordables aux grossistes et aux distributeurs \u00e0 travers les \u00c9tats-Unis.<\/span><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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R\u00e9sum\u00e9<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Lorsque Amici Pharmaceuticals s'est lanc\u00e9e, la loi DSCSA venait d'\u00eatre promulgu\u00e9e. Apr\u00e8s avoir \u00e9valu\u00e9 les partenaires potentiels pour r\u00e9pondre aux exigences, l'entreprise a choisi Systech pour sa solution compl\u00e8te UniTrace et son syst\u00e8me \u00e9prouv\u00e9 de contr\u00f4le de la qualit\u00e9. <\/span>ant\u00e9c\u00e9dents<\/span> avec les CMO. Dix ans plus tard, Systech <\/span>reste<\/span> Le partenaire de choix d'Amici pour naviguer dans le paysage complexe de la tra\u00e7abilit\u00e9 et de la conformit\u00e9.<\/span><\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\"Gr\u00e2ce \u00e0 Systech, nos produits sont trait\u00e9s et distribu\u00e9s plus rapidement, ce qui nous permet de minimiser les p\u00e9nalit\u00e9s de retard d'approvisionnement, ce qui est crucial dans notre industrie.<\/span><\/span>\"\u00a0<\/em><\/p><\/span><\/blockquote><\/div><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Paul Baluyot<\/span>, <\/span>Directeur principal de la technologie, Amici Pharmaceuticals<\/span><\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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D\u00e9fi<\/h2><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\u00c9volutif<\/span> s\u00e9rialisation<\/span> pour un<\/span> virtuel <\/span>fabricant<\/span><\/span>\u00a0<\/span><\/strong><\/p>

Lors du lancement d'Amici Pharmaceuticals, la s\u00e9rialisation \u00e9tait int\u00e9gr\u00e9e dans le syst\u00e8me. <\/span>initial<\/span> plan. La loi sur la s\u00e9curit\u00e9 de la cha\u00eene d'approvisionnement en m\u00e9dicaments (DSCSA)<\/a> venait d'\u00eatre promulgu\u00e9e. En tant que petit acteur entrant sur le march\u00e9 des produits pharmaceutiques g\u00e9n\u00e9riques, Amici a \u00e9t\u00e9 confront\u00e9 \u00e0 la d\u00e9cision de mettre en place un syst\u00e8me de s\u00e9rialisation interne ou de rechercher une solution externe.<\/span> Amanda <\/span>Samojedny<\/span>Vice-pr\u00e9sident des op\u00e9rations chez Amici, explique : \"Nous \u00e9tions une si petite entreprise, et nous \u00e9tions si nouveaux, que nous n'avons pas eu le temps de nous concentrer sur notre travail. <\/span>n'a pas<\/span> Nous n'avions pas vraiment le fardeau de la mise \u00e0 niveau d'un grand portefeuille. Cependant, nos ressources internes \u00e9taient limit\u00e9es et il y avait beaucoup d'incertitude quant \u00e0 l'\u00e9volution des exigences r\u00e9glementaires.<\/span><\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\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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Systech's<\/span> UniTrace - Suivi et tra\u00e7abilit\u00e9 de la cha\u00eene d'approvisionnement<\/span>\u00a0plateforme<\/span><\/span><\/strong><\/p>

Apr\u00e8s avoir \u00e9valu\u00e9 des partenaires potentiels, Amici a choisi Systech pour les guider dans leur d\u00e9marche de mise en conformit\u00e9. La suite UniTrace\u00ae de Systech<\/a> offre une \u00e9volutivit\u00e9, une mise en \u0153uvre rapide et une solution de conformit\u00e9 compl\u00e8te. De plus, la r\u00e9putation de Systech et ses relations \u00e9troites avec les organisations de fabrication sous contrat (CMO) ont \u00e9t\u00e9 des facteurs cl\u00e9s dans la d\u00e9cision.<\/span>\u00a0<\/span><\/p>

\"Systech a \u00e9t\u00e9 le choix \u00e9vident pour nous parce qu'ils ont offert une approche plus personnalis\u00e9e pour le d\u00e9ploiement d'un syst\u00e8me de gestion de l'information. s\u00e9rialisation<\/a> Ce qui \u00e9tait essentiel pour nous en tant que petite entreprise\", a d\u00e9clar\u00e9 M. Samojedny. \"Ils sont devenus une extension de notre \u00e9quipe, nous apportant l'expertise et le soutien dont nous avions besoin sans avoir \u00e0 mettre en place une vaste infrastructure interne.<\/span>\u00a0<\/span><\/p>

Au fur et \u00e0 mesure que les activit\u00e9s d'Amici se sont d\u00e9velopp\u00e9es, le service de v\u00e9rification des routeurs de Systech a \u00e9t\u00e9 mis en place. (VRS)<\/a> est entr\u00e9e en jeu pour permettre la v\u00e9rification des retours vendables. La mise en \u0153uvre s'est d\u00e9roul\u00e9e sans probl\u00e8me, gr\u00e2ce \u00e0 une \u00e9troite collaboration avec l'\u00e9quipe d'ing\u00e9nieurs de Systech. VRS a encore am\u00e9lior\u00e9 les capacit\u00e9s de conformit\u00e9 DSCSA, permettant \u00e0 Amici de g\u00e9rer efficacement les retours de produits conform\u00e9ment aux exigences r\u00e9glementaires.<\/span>\u00a0<\/span><\/p>

Les relations \u00e9troites que Systech entretient avec les CMO garantissent une mise en \u0153uvre et un \u00e9change de donn\u00e9es sans faille. Comme le dit Paul Baluyot, directeur principal de la technologie chez Amici, \"vous faites confiance \u00e0 vos CMO et ils font confiance \u00e0 Systech\". Ce r\u00e9seau de confiance simplifie le r\u00e9seau complexe de relations dans la cha\u00eene d'approvisionnement pharmaceutique.<\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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R\u00e9sultats<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Mise en conformit\u00e9 pr\u00e9coce avec la DSCSA et rationalisation des op\u00e9rations<\/span><\/span>\u00a0<\/span><\/strong><\/p>

Amici a adopt\u00e9 tr\u00e8s t\u00f4t les lignes directrices de la DSCSA, en s\u00e9rialisant les produits et en \u00e9changeant des donn\u00e9es bien avant les \u00e9ch\u00e9ances r\u00e9glementaires. Cette pr\u00e9paration a fait de l'entreprise un partenaire id\u00e9al pour les programmes pilotes avec d'autres entreprises qui en sont encore \u00e0 la phase de mise en \u0153uvre.<\/span>\u00a0<\/span><\/p>

L'approche proactive de l'entreprise a permis d'am\u00e9liorer les relations avec les partenaires commerciaux. Baluyot explique : \"Nous avons \u00e9t\u00e9 les premiers McKesson 3PL<\/a> Le client de Systech a b\u00e9n\u00e9fici\u00e9 des services de l'entrep\u00f4t de Mason, dans l'Ohio, ce qui a renforc\u00e9 notre relation avec lui. Notre collaboration avec Systech nous a permis non seulement d'approfondir notre compr\u00e9hension des complexit\u00e9s de la DSCSA, mais aussi d'am\u00e9liorer nos processus communs\".<\/span>\u00a0<\/span><\/p>

La mise en \u0153uvre des alertes UniTrace de Systech a permis d'am\u00e9liorer consid\u00e9rablement la gestion des stocks et la distribution. \"Gr\u00e2ce \u00e0 Systech, nos produits sont trait\u00e9s et distribu\u00e9s plus rapidement, ce qui nous permet de minimiser les p\u00e9nalit\u00e9s de retard d'approvisionnement, ce qui est crucial dans notre secteur\", a ajout\u00e9 M. Baluyot.<\/span>\u00a0<\/span><\/p>

La solution de tra\u00e7abilit\u00e9 de Systech a non seulement soutenu la conformit\u00e9 initiale d'Amici, mais a \u00e9galement \u00e9tabli un cadre pour une conformit\u00e9 continue au fur et \u00e0 mesure de l'\u00e9volution des r\u00e9glementations. L'approche de la validation bas\u00e9e sur le risque du syst\u00e8me s'aligne sur les meilleures pratiques de l'industrie pharmaceutique, permettant \u00e0 Amici de g\u00e9rer efficacement la conformit\u00e9 sans surcharger les ressources internes. Une documentation compl\u00e8te, comprenant des plans de validation, des cas de test et des rapports de synth\u00e8se, a permis de rationaliser les efforts de mise en conformit\u00e9 d'Amici.<\/span>\u00a0<\/span><\/p>

Au fur et \u00e0 mesure qu'Amici d\u00e9veloppait ses activit\u00e9s, l'\u00e9volutivit\u00e9 d'UniTrace s'est av\u00e9r\u00e9e inestimable. La solution compl\u00e8te de Systech a fourni \u00e0 Amici des capacit\u00e9s de conformit\u00e9, de gestion des exceptions et de reprise, ce qui a permis de gagner du temps et de r\u00e9duire les ressources. Cette approche globale a permis de r\u00e9duire le co\u00fbt total de possession. (TCO)<\/a> pour les Amici, et la possibilit\u00e9 de se concentrer sur l'activit\u00e9 principale tout en maintenant la conformit\u00e9 \u00e0 la DSCSA.<\/span>\u00a0<\/span><\/p>

L'avantage Amici, c'est Systech : Un partenariat inestimable<\/span><\/b>\u00a0<\/span><\/p>

Pour Amici Pharmaceuticals, le partenariat avec Systech a \u00e9t\u00e9 transformateur. L'expertise, la technologie et le soutien de Systech ont \u00e9t\u00e9 essentiels pour permettre \u00e0 Amici d'atteindre la conformit\u00e9 DSCSA, d'am\u00e9liorer ses op\u00e9rations, de renforcer ses partenariats et de se positionner en tant que leader de l'industrie.<\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Vous \u00eates \u00e0 la recherche du bon partenaire en mati\u00e8re de conformit\u00e9 pharmaceutique ? <\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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D\u00e9couvrez comment la solution de conformit\u00e9 DSCSA de Systech et la plateforme UniTrace peuvent transformer vos op\u00e9rations pharmaceutiques.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\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\tEN SAVOIR PLUS<\/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<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

\u00c9tude de cas | Le fabricant virtuel minimise le risque de retards d'exp\u00e9dition avec Systech UniTrace\u00ae pour la conformit\u00e9, la gestion des exceptions et la reprise \"Systech a \u00e9t\u00e9 le choix \u00e9vident pour nous parce qu'ils ont offert une approche plus personnalis\u00e9e pour d\u00e9ployer une solution de s\u00e9rialisation, ce qui \u00e9tait critique pour nous en tant que petite entreprise.\" - Amanda Samojedny, VP des op\u00e9rations, Amici Pharmaceuticals Client [...]<\/p>","protected":false},"author":34,"featured_media":29006,"parent":20962,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-28858","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"\nVirtual manufacturer minimizes shipping delays and prevents revenue loss<\/title>\n<meta name=\"description\" content=\"Learn how Amici Pharmaceuticals achieved DSCSA compliance with Systech's pharma traceability solution in this traceability case study.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/staging.systech.ssdev.ca\/fr\/case-studies\/virtual-manufacturer-unitrace-compliance-exceptions-management-rework\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Virtual manufacturer minimizes shipping delays and prevents revenue loss\" \/>\n<meta property=\"og:description\" content=\"Learn how Amici Pharmaceuticals achieved DSCSA compliance with Systech's pharma traceability solution in this traceability case study.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/staging.systech.ssdev.ca\/fr\/case-studies\/virtual-manufacturer-unitrace-compliance-exceptions-management-rework\/\" \/>\n<meta property=\"og:site_name\" content=\"Systech\" 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