Ympronta Bloghttps://www.ympronta.it/blog/12024-03-14T17:30:20ZCome gestire il rischio in un mondo interconnessohttps://www.ympronta.it/blog/ympronta-blog-1/come-gestire-il-rischio-in-un-mondo-interconnesso-29Info YmprontaSIAMO PRONTI A FRONTEGGIARE I RISCHI IN UN MONDO COSI’ INTERCONNESSO? Oggi siamo sempre più interconnessi ed è sempre più complesso difenderci dai numerosi “cyber attack”. Siamo di fronte a una vera e...2024-03-14T17:30:20ZLe novità della guida GAMP 5 Second Editionhttps://www.ympronta.it/blog/ympronta-blog-1/le-novita-della-guida-gamp-5-second-edition-28Info YmprontaA partire dalla fine di luglio 2022, è stata resa disponibile la seconda edizione della guida GAMP 5: pur mantenendo invariati i principi di base rispetto all’edizione del 2008, sono presenti aggiorna...2024-01-16T16:33:03ZLa serializzazione dei farmacihttps://www.ympronta.it/blog/ympronta-blog-1/la-serializzazione-dei-farmaci-26Ympronta srlIl settore farmaceutico è sicuramente quello in cui la serializzazione dei prodotti è più avanzata. I motivi sono diversi: il primo, banalmente, è che in tale settore la serializzazione è resa obbliga...2024-01-11T10:59:18ZImpatti Negativi di Data Integrity sulle aziende Pharmahttps://www.ympronta.it/blog/ympronta-blog-1/impatti-negativi-di-data-integrity-sulle-aziende-pharma-25Info YmprontaAbbiamo sempre affrontato il tema Data Integrity dal punto di vista degli obblighi imposti dagli enti regolatori, da una parte, e dei benefici che si potranno ottenere, dall’altra. Ma come qualsiasi p...2021-07-17T12:43:23ZQualità 4.0: Perché la cultura digitale deve essere di massima priorità per i QA Manager?https://www.ympronta.it/blog/ympronta-blog-1/qualita-4-0-perche-la-cultura-digitale-deve-essere-di-massima-priorita-per-i-qa-manager-24Info YmprontaLe forme della tecnologia avanzata sono ormai illimitate: Intelligenza Artificiale, Blockchain, IoT, Cloud, solo per citarne alcune. E sta cambiando rapidamente il modo in cui le aziende farmaceutiche...2021-07-04T16:25:05ZApplicazioni di IA nel farmaceuticohttps://www.ympronta.it/blog/ympronta-blog-1/applicazioni-di-ia-nel-farmaceutico-23Info YmprontaNell'articolo precedente " Quello che le macchine apprendono " abbiamo conosciuto i concetti fondamentali dell'intelligenza artificiale. Abbiamo visto che l'intelligenza artificiale, o meglio, Machine...2021-06-20T23:32:56ZWhat machines learnhttps://www.ympronta.it/blog/ympronta-blog-1/what-machines-learn-22Info YmprontaArtificial Intelligence has been part of our reality for several years now. Each of us comes into contact with it every day, in a more or less conscious way. Movies suggested by Netflix, the most appr...2021-05-30T12:45:26ZAre "Best Practices" still the best criteria for selecting and implementing an eQMS?https://www.ympronta.it/blog/ympronta-blog-1/are-best-practices-still-the-best-criteria-for-selecting-and-implementing-an-eqms-21Info YmprontaThe first Best Practices on Quality Management in Pharmaceutical Organizations date back almost 100 years. The book " The Principles of Scientific Management " by engineer Frederick Winslow Taylor, wh...2021-04-25T13:30:57ZThe essential components of a modern eQMS software for pharmaceutical companieshttps://www.ympronta.it/blog/ympronta-blog-1/the-essential-components-of-a-modern-eqms-software-for-pharmaceutical-companies-20Info Ympronta"The quality and production volumes are incompatible... if quality improves, volumes decrease, and vice versa... How much can we reduce quality without losing customers?" Thus begins the famous book "...2021-03-25T16:53:51ZThe main trends in Quality Assurance to keep an eye on in 2021https://www.ympronta.it/blog/ympronta-blog-1/the-main-trends-in-quality-assurance-to-keep-an-eye-on-in-2021-19Info YmprontaThe pharmaceutical industry is among the most conservative from the point of view of technological innovations. Even in digitization, the Life Science sector has always been the "tail-end". The FDA wa...2021-03-12T10:02:59ZHow much does a paper-based QMS really cost?https://www.ympronta.it/blog/ympronta-blog-1/how-much-does-a-paper-based-qms-really-cost-18Info YmprontaPaper might seem like a convenient option for managing production data, batch records, SOPs, trainings, CAPAs, change controls, validations, etc. Paper management is still widespread among many pharma...2021-02-25T18:22:55ZComplying with FDA regulations may be easier than you thinkhttps://www.ympronta.it/blog/ympronta-blog-1/complying-with-fda-regulations-may-be-easier-than-you-think-17Info YmprontaComplying with FDA guidelines on Data Integrity may be easier than you think The official data integrity guidelines have been in full force for more than 5 years now. There is no Life Sciences profess...2021-02-09T11:48:55ZThe hospitals rebelion against serializationhttps://www.ympronta.it/blog/ympronta-blog-1/the-hospitals-rebelion-against-serialization-14Info YmprontaThe hospitals rebelion against serialization The current Falsified Medicines Directive (FMD) begins its history in 2011 and wants to replace the previous directive, issued in 2001. The culmination too...2021-01-11T13:39:03ZTell me what you think about Data Integrity and I'll tell you who you arehttps://www.ympronta.it/blog/ympronta-blog-1/tell-me-what-you-think-about-data-integrity-and-i-ll-tell-you-who-you-are-13Info YmprontaTell me what you think about Data Integrity and I'll tell you who you are Many companies in the pharmaceutical sector see Data Integrity legislation as just an obligation to be respected. Indeed, as t...2020-05-29T09:21:04ZThe greatest obstacle to Data Integrityhttps://www.ympronta.it/blog/ympronta-blog-1/the-greatest-obstacle-to-data-integrity-11Info YmprontaThe greatest obstacle to Data Integrity Have you ever wanted to literally observe a datum along its journey through business processes? Do you think it is impossible? Since the Data Integrity requires...2020-05-13T17:58:49Z