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Industry 4.0 has further amplified the importance of horizontal and vertical integration, making them the very backbone on which the Smart Factory is built. The terms “horizontal integration” and “vertical integration” are familiar from a number of contexts. From the operational perspective, a horizontally integrated company focuses its activities around its core competencies and establishes partnerships to build out an end-to-end value chain. A vertically integrated company, on the other hand, keeps as much of its value chain in-house as it can—from product development to manufacturing, marketing, sales, and distribution. In the world of  business growth  strategy, horizontal integration refers to the acquisition of companies that address the same customer base with different but complementary products or services. In this way, the acquiring company can increase market share, diversify their product offerings, and so on. A vertical growth strategy, on the other hand, involves...

2. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your firm lacked controls necessary to assure the integrity of electronic test data. Specifically, you failed to implement sufficient controls to support the integrity of your data and to ensure that only appropriate individuals had administrative rights. Notably, a demonstration performed during the inspection revealed that the computer operating the  (b)(4)  spectrophotometer (ID: L-563) was not secured such that data files could be deleted without the knowledge of your quality unit . This instrument was used for finished product release and stability testing for several drug products. Your response was inadequate because it failed to include a comprehensive review of all laboratory instruments to determine whether all user roles are appropriate . You ack...

1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). You manufacture topical analgesic drug products, including “After Bite,” for the treatment of insect bite-related itching and burning in adults and children. Analytical records at your firm did not accurately represent the testing performed . For example, you injected samples on your high performance liquid chromatography (HPLC) system and did not include them in the laboratory records that were used by your Quality Unit (QU) for batch disposition decisions, including finished product release. Your laboratory management could not provide an adequate explanation for these unofficial injections to our investigator. In addition, you failed to have the proper controls in place to prevent the unauthorized manipulation of laboratory raw electronic data. For example, your Infrared Spectrophotomete...

Transformation digitale :  La crise de la Covid-19 a servi de rampe de lancement à la pratique de la téléconsultation. Mais médecins comme patients sont-ils prêts à passer à l'étape supérieure de la santé connectée ? Même si les objets connectés font de plus en plus partie de notre quotidien, la transition pourrait prendre encore quelques années. Par  Clarisse Treilles   | Modifié le  jeudi 30 juil. 2020 à 12:21 0 Réactions Tweet Partager plus + Compter le nombre de pas réalisés dans sa journée, calculer son IMC, prévenir les risques de diabète, contrôler sa fréquence cardiaque après un effort physique... les objets connectés dédiés au bien-être et à la santé font désormais partie du quotidien de bon nombre d'utilisateurs. De simples gadgets ludiques, aux montres connectées et autres appareils sophistiqués à usage médical, il existe souvent un gap entre tous ces dispositifs, qui de facto ne sont pas à la portée de toutes les bourses. Pourtant, la crise de la Cov...

Automation, artificial intelligence, augmented reality and robotics are among the tools manufacturers can deploy to benefit from radical digital transformation. As the world awaits a Covid-19 vaccine, the cold truth is that finding an effective vaccine is only the first step. Even if one is approved for use, however, a distinct manufacturing and supply chain challenge lies ahead. “Seven billion of us are going to need this vaccine and it’ll be challenging to do it in a production & wider supply chain environment that isn’t designed to increase its output at that rate in such a short space of time,” says Mark Purcell, President and COO of digital manufacturing specialists CXV Global... Link to article - CLICK HERE

Volkswagen, qui s'est associé à AWS et son partenaire d'intégration Siemens pour son cloud industriel, annonce son intention d'intégrer de nouveaux partenaires technologiques à ce vaste projet en faveur d'une industrie 4.0. « Les nouvelles entreprises partenaires pourront se connecter aux usines de Volkswagen et apporter leurs propres applications logicielles pour l'optimisation des processus de production dans le cloud industriel »,  indique  le constructeur allemand dans un communiqué. La plateforme IoT déployée avec AWS réunit à la fois les données des machines, des usines et de tous les systèmes sur l'ensemble des sites du groupe. Ce  grand plan de Volkswagen , qui s'appuie sur le cloud computing et les technologies de l'IoT, prévoit de connecter et gérer ses 122 usines de fabrication et sa chaîne logistique. A terme, Volkswagen Industrial Cloud connectera  plus de 30 000 installations et 1 500 fournisseurs  et...

2. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your firm lacked controls necessary to assure the integrity of electronic test data. Specifically, you failed to implement sufficient controls to support the integrity of your data and to ensure that only appropriate individuals had administrative rights. Notably, a demonstration performed during the inspection revealed that the computer operating the  (b)(4)  spectrophotometer (ID: L-563) was not secured such that data files could be deleted without the knowledge of your quality unit . This instrument was used for finished product release and stability testing for several drug products. Your response was inadequate because it failed to include a comprehensive review of all laboratory instruments to determine whether all user roles are appropriate...