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IBCS Poland gotowe na UDI
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Już wymaga tego Amerykańska Agencja ds. Żywności i Leków, a wkrótce tym śladem pójdzie także Komisja Europejska. O czym mowa? O tzw. UDI, czyli o Unikalnej Identyfikacji Wyrobów Medycznych. I choć czasu na jej wdrożenie jeszcze trochę zostało, to my jesteśmy na to gotowi już teraz.
UDI to system służący do oznaczania i identyfikacji urządzeń medycznych w globalnym łańcuchu dostaw z zakresu opieki zdrowotnej. I choć decyzją Komisji Europejskiej UDI zacznie obowiązywać dopiero od 26 maja 2021 roku, to w przypadku IBCS Poland wszystko jest już dopięte na ostatni guzik.
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W USA to już norma, w UE niedługo też wejdzie to w życie
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Do tej pory z Unikalną Identyfikacją Wyrobów Medycznych mieli do czynienia ci, którzy eksportowali na przykład urządzenia medyczne na rynek amerykański. Ich zadaniem było znakowanie swoich wyrobów właśnie zgodnie z UDI.
Wkrótce będzie to dotyczyć znacznie większej grupy osób, bo taki sam system znakowania wprowadzą także kraje Unii Europejskiej. W przejściu przez meandry jednoznacznego znakowania wszystkich produktów medycznych pomaga GS1, czyli wiodąca organizacja opracowująca i wdrażająca globalne standardy łańcucha dostaw. To właśnie tę organizację Komisja Europejska obdarzyła zaufaniem w kwestii nadawania identyfikatorów UDI. I to właśnie z GS1 nasza współpraca funkcjonuje od wielu lat.
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IBCS Poland a GS1
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Nasza spółka jest partnerem organizacji GS1 w zakresie poprawy wydajności i zyskowności przedsiębiorstw w całym łańcuchu dostaw. Współpraca obejmuje m.in. uczestnictwo IBCS Poland w GS1 Polska. Daje nam także prawo do posługiwania się znakiem „Zgodny z GS1” dla swoich produktów.
Od lat dostarczamy rozwiązania oparte na standardach GS1, na co dzień wspierając przedsiębiorców w ich bieżących działaniach. W naszej ofercie znajdują się propozycje także dla handlowców, dostawców i serwisantów. Sam GS1 sprawdza się na wielu płaszczyznach w związku z tym, że jest standardem spójnym na skalę światową.
Wieloletnie doświadczenie na rzecz wdrażania globalnych standardów GS1 teraz możemy zastosować przy wprowadzaniu UDI na rynku europejskim. Zadania takie, jak umieszczanie kodów na różnego rodzaju materiałach, czy korzystanie chociażby z drukarek z aplikatorem etykiet nie stanowią dla nas żadnego problemu. Mało tego! Korzystamy z tego w wielu łańcuchach dostaw. Teraz czas na wykorzystanie tych umiejętności w branży obejmującej materiały medyczne.
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NiceLabel – projekt etykiet zgodny z UDI
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NiceLabel to oprogramowanie do projektowania i zarządzania etykietami. Za pomocą tego środowiska można w łatwy sposób tworzyć etykiety zgodne ze standardami UDI, jak i co najważniejsze mamy pełny wgląd w historię wykonanych działań na etykiecie (wprowadzanie zmian, ilość wydrukowanych itd.). Za pomocą NiceLabel możemy również synchronizować wymagane informacje z zewnętrznymi bazami danych. NiceLabel może być instalowany u klienta i działać lokalnie, może też być udostępniony po przez chmurę IBCS jako rozwiązanie SaaS.
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Oprogramowanie NiceLabel designer daje możliwość samodzielnego tworzenia etykiet zgodnych ze standardem UDI. Edytor etykiet wyposażony jest w funkcje projektowania graficznego, które umożliwiają przygotowanie etykiet zgodnych z UDI w ciągu kilku minut bez konieczności kodowania czy posiadania specjalistycznej wiedzy w zakresie wymaganego formatu danych.
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Za pomocą prostych formularzy drukowania, można projektować panele operatorskie, dzięki którym operator może wybrać etykietę i produkt zgodnie a aktualną partią na linii produkcyjnej. Taki panel może być udostępniony lokalnie lub też zdalnie za pomocą chmury IBCS.
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W środowisku NiceLabel Control Center możemy przechowywać w wirtualnym katalogu wszystkie projekty. Mamy dostęp do historii druku, czy wprowadzonych zmian w etykiecie
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W bardzo łatwo w sposób graficzny możemy porównać różne wersje tej samej etykiety. Bez tej funkcjonalności byłoby bardzo trudno szybko znaleźć różnice pomiędzy poszczególnymi wersjami
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Uruchom darmowego kreatora etykiet do znakowania wyrobów medycznych w NiceLabel Cloud, otrzymasz etykietę zgodną ze standardami UDI / GS1
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Znakowanie wyrobów medycznych, czyli wszystko co musisz wiedzieć o UDI
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Wysyłając formularz wyrażasz zgodę na przetwarzanie swoich danych osobowych
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Materiał opracowany przy współpracy z GS1 – oficjalną agencją akredytowaną przez FDA oraz przez KE, odpowiedzialną za nadawanie identyfikatorów UDI jak i wdrożenie standardów UDI na terenie naszego kraju.
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