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Sérialisation pharmaceutique : Ekium recommande la solution Adents

Ekium, acteur majeur de l’ingénierie et de l’intégration annonce l’obtention de la certification Solution Partners d’Adents, l’éditeur de logiciels d’identification unitaire et de traçabilité. Ekium commercialise et intègre en France l’offre clé main d’Adents comprenant sa solution logicielle de sérialisation et son réseau de partenaires machine qualifiés.

Pour renforcer la sécurité du circuit de distribution et lutter contre les médicaments contrefaits, une quarantaine de pays dans le monde se sont dotés de réglementations imposant l’identification de chaque boite de médicament par un numéro de série unique.

D'ici 2020, plus de 90% des médicaments prescrits dans le monde devront être sérialisés. L’enjeu pour les laboratoires pharmaceutiques et les façonniers est de se mettre en conformité dans les délais impartis. Pour le marché européen, et selon la directive EU 2016/161, la sérialisation sera obligatoire à partir du 9 février 2019.

La réglementation européenne qui impose aussi un dispositif anti-effraction, ajoutée aux spécificités inhérentes à chaque pays, implique d’importants changements de modes opératoires sur les lignes de production. Les industriels, soucieux de préserver le niveau de productivité de leurs sites, sont donc à la recherche d'experts techniques pour les accompagner.

Ekium a compris très tôt que la sérialisation n’était pas simplement une problématique «machine » mais qu’il fallait également s’attaquer à la gestion complexe des numéros de série impliquant le déploiement d’un logiciel flexible, capable d’évoluer dans un environnement réglementaire en constante évolution. C’est la raison pour laquelle Ekium a été parmi les premiers intégrateurs à rejoindre le programme de certification Adents Solution Partners.

Ce programme permet aux intégrateurs de monter en compétence sur la commercialisation et le déploiement de la solution logicielle Adents.

Selon Laurent Perrin, Directeur Général Ekium :

« La mise en œuvre de la sérialisation dans les délais impartis nécessite une solution rapide et facile à installer. La solution logicielle Adents nous a convaincus par sa rapidité de paramétrage au niveau du site et sa capacité à s’adapter facilement aux règlementations. Les réactions positives de nos clients dans les projets en cours nous confortent dans ce choix. »

Cyril Chantrier, Directeur Solution Partners Adents, ajoute :

« Nous sommes très heureux de compter Ekium, membre du réseau d’intégrateurs Siemens, parmi nos tous premiers partenaires certifiés. Ekium dispose d’une grande expérience en matière d’ingénierie dans l’industrie pharmaceutique grâce à des projets menés pour Galderma, BioMérieux, Ipsen, Sanofi, Virbac ou encore Valdepharm. De plus, sa couverture nationale lui permet d’être réactif dans la gestion, la réalisation et la maintenance de projets de sérialisation multi-sites.».

A propos d’Adents :

Editeur référent de solutions logicielles d’identification et de traçabilité unitaires, Adents permet aux laboratoires pharmaceutiques et aux façonniers de s’adapter aux évolutions de leurs marchés et de se conformer aux réglementations en vigueur en matière de traçabilité.

Adents Seriza est la solution de sérialisation pour les sites de production retenue par Siemens pour ses clients.

Adents Prodigi est la solution co-développée avec Microsoft qui s’appuie sur les dernières technologies Azure pour échanger et valoriser les données de sérialisation en toute sécurité. La société Adents est présente dans le monde entier à travers un large réseau de partenaires experts et ses filiales en Europe et aux Etats-Unis. www.adents.com - @Adentsinfo

A propos de Ekium :

Ekium est une société d’ingénierie et d’intégration en informatique industrielle et en automation, reconnue comme acteur précurseur de la "smart industrie". Ekium est un groupe de 750 personnes, pour un chiffre d'affaire de 70 M €. Il est représenté par 16 implantations en France et mène plus de 150 projets à l'International

Nous avons trois activités principales :

- L’Ingénierie globale « Tout corps d’état » en Industrielle et Tertiaire: Process, Installation générale, Tuyauterie, Structure, Electricité, Instrumentation, …

- L’intégration Automation : Automatisme, Sérialisation, M.E.S / M.O.M, IoT, Machine Spéciale, Robotique de laboratoire, …

- La Maintenance : Ingénierie de Maintenance, MCO, TMA, Infogérance Industrielle, Gestion des Astreintes, ...

Notre vocation est d'accompagner les industriels sur le cycle de vie de leur projet et sur toutes les activités et d'aborder avec eux les enjeux majeurs qui se présentent à nous.

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