{"id":20411,"date":"2023-10-17T09:30:00","date_gmt":"2023-10-17T13:30:00","guid":{"rendered":"https:\/\/www.systechone.com\/systech-showcases-solutions-to-eliminate-supply-chain-risks-at-pack-expo-las-vegas-2023-2\/"},"modified":"2025-08-19T12:21:12","modified_gmt":"2025-08-19T16:21:12","slug":"systech-advises-that-stabilization-period-is-no-excuse-for-delayed-compliance","status":"publish","type":"post","link":"https:\/\/www.systechone.com\/pt\/systech-advises-that-stabilization-period-is-no-excuse-for-delayed-compliance\/","title":{"rendered":"DSCSA 2023: A Systech informa que o per\u00edodo de estabiliza\u00e7\u00e3o n\u00e3o \u00e9 desculpa para atrasos na conformidade\u00a0"},"content":{"rendered":"
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DSCSA 2023: A Systech informa que o per\u00edodo de estabiliza\u00e7\u00e3o n\u00e3o \u00e9 desculpa para atrasos na conformidade <\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\u00a0<\/em><\/p>

A Systech aconselha o setor farmac\u00eautico a manter o ritmo em meio ao per\u00edodo de estabiliza\u00e7\u00e3o da DSCSA e aos prazos iminentes<\/em>\u00a0<\/p>

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Princeton, NJ, 17 de outubro de 2023 -<\/strong> Em vista do recente an\u00fancio da FDA sobre um atraso na aplica\u00e7\u00e3o da Lei de Seguran\u00e7a da Cadeia de Suprimentos de Medicamentos (DSCSA), Systech<\/a>A Markem-Imaje Inc., parte da Markem-Imaje e da Dover, e fornecedora l\u00edder de solu\u00e7\u00f5es de software de identifica\u00e7\u00e3o digital e rastreabilidade, adverte o setor contra a complac\u00eancia.\u00a0<\/p>

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\"Embora a decis\u00e3o da FDA de oferecer essa pausa possa proporcionar um al\u00edvio tempor\u00e1rio das repercuss\u00f5es da aplica\u00e7\u00e3o da lei, esse per\u00edodo deve ser visto como uma oportunidade de ouro para testar e refinar as estrat\u00e9gias e os processos de conformidade com a DSCSA\", disse Sreedhar Patnala, vice-presidente de produtos. \"Os riscos na constru\u00e7\u00e3o de uma cadeia de suprimentos farmac\u00eautica interoper\u00e1vel s\u00e3o altos demais para serem ignorados, e os benef\u00edcios da conformidade total com a DSCSA v\u00e3o al\u00e9m da mera ades\u00e3o \u00e0 regulamenta\u00e7\u00e3o.\"\u00a0<\/p>

<\/p>

As exig\u00eancias da DSCSA ainda est\u00e3o definidas para entrar em vigor em 27 de novembro de 2023, com o per\u00edodo de estabiliza\u00e7\u00e3o se estendendo at\u00e9 27 de novembro de 2024. \u00c9 imprescind\u00edvel que as entidades de toda a cadeia de suprimentos farmac\u00eautica tenham tecnologias avan\u00e7adas implementadas neste outono e ajustem seus processos para garantir uma transi\u00e7\u00e3o perfeita quando a aplica\u00e7\u00e3o come\u00e7ar. A FDA fornece uma vis\u00e3o geral do Principais requisitos de seguran\u00e7a da cadeia de suprimentos<\/a>.\u00a0<\/p>

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Para fabricantes, atacadistas e distribuidores, o per\u00edodo de estabiliza\u00e7\u00e3o \u00e9 crucial para garantir que as tecnologias para conex\u00f5es de dados e verifica\u00e7\u00f5es de produtos estejam em vigor. Para farm\u00e1cias e hospitais, em particular, esse per\u00edodo \u00e9 fundamental para refinar os sistemas de conformidade e resolver problemas de desalinhamento de dados e produtos.\u00a0<\/p>

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\"O sistema geral precisa lidar com bilh\u00f5es de transa\u00e7\u00f5es por ano. Uma coisa \u00e9 fazer um teste de desempenho em um ambiente de teste. Mas durante a produ\u00e7\u00e3o real, tudo precisa funcionar de ponta a ponta\", disse Gregg Gorniak, vice-presidente de opera\u00e7\u00f5es de fabricantes e servi\u00e7os de dados da Cencora (antiga AmerisourceBergen). \"Para chegar onde precisamos estar durante o per\u00edodo de estabiliza\u00e7\u00e3o, temos que ver mais dados.\"\u00a0<\/p>

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Benef\u00edcios do neg\u00f3cio global de embalagens com as solu\u00e7\u00f5es da Systech<\/strong>\u00a0<\/p>

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A Nutra-Med Packaging, uma empresa de embalagem por contrato que atende aos setores farmac\u00eautico, de sa\u00fade e de dispositivos m\u00e9dicos, escolheu a Systech para ajudar a obter e manter a conformidade com a DSCSA e a rastreabilidade da cadeia de suprimentos.\u00a0\u00a0<\/p>

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\"O atraso na aplica\u00e7\u00e3o da DSCSA certamente ter\u00e1 s\u00e9rias repercuss\u00f5es daqui a um ano. Ao adiar as fun\u00e7\u00f5es necess\u00e1rias, como a agrega\u00e7\u00e3o, as organiza\u00e7\u00f5es adiar\u00e3o as vantagens das solu\u00e7\u00f5es de rastreamento e monitoramento da DSCSA\", disse Kunal Gupta, CEO da Nutra-Med. \"A experi\u00eancia da Systech em serializa\u00e7\u00e3o e rastreabilidade farmac\u00eautica possibilitou essas vantagens para nossos neg\u00f3cios, al\u00e9m de garantir que nossa opera\u00e7\u00e3o esteja em conformidade.\"\u00a0<\/p>

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O setor farmac\u00eautico e o alinhamento de dados<\/strong>\u00a0<\/p>

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As farm\u00e1cias est\u00e3o na jun\u00e7\u00e3o cr\u00edtica entre a cadeia de suprimentos de medicamentos e o consumidor, servindo como o ponto de contato final. O per\u00edodo de estabiliza\u00e7\u00e3o oferece uma oportunidade de refinar a conex\u00e3o de dados e os processos de verifica\u00e7\u00e3o de produtos, que s\u00e3o elementos fundamentais para a conformidade.\u00a0<\/p>

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\"A NABP ap\u00f3ia a decis\u00e3o da FDA de oferecer um per\u00edodo de estabiliza\u00e7\u00e3o para a DSCSA\", disse o Diretor Executivo\/Secret\u00e1rio da NABP, Lemrey \"Al\" Carter, PharmD, MS, RPh. \"Toda a cadeia de suprimentos deve continuar progredindo em dire\u00e7\u00e3o \u00e0 conformidade. As farm\u00e1cias, em particular, devem aproveitar o tempo adicional para garantir que tenham sistemas e processos em vigor para cumprir a norma. A ado\u00e7\u00e3o antecipada do VRS pela Systech e o desejo de se tornar um parceiro de interoperabilidade da Pulse demonstram seu compromisso com as farm\u00e1cias de todo o pa\u00eds e est\u00e3o alinhados com nosso objetivo de proteger ainda mais a cadeia de suprimentos de medicamentos para proteger a sa\u00fade p\u00fablica.\"\u00a0\u00a0<\/p>

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O desalinhamento de dados e produtos n\u00e3o pode ser considerado levianamente, dado o volume de prescri\u00e7\u00f5es preenchidas anualmente nos EUA. O ano extra oferece uma chance de estabelecer processos tranquilos que garantam a transi\u00e7\u00e3o para o novo cen\u00e1rio regulat\u00f3rio.\u00a0<\/p>

<\/p>

UniTrace: Uma solu\u00e7\u00e3o abrangente para a conformidade com a DSCSA<\/strong>\u00a0<\/p>

<\/p>

A su\u00edte UniTrace da Systech oferece uma solu\u00e7\u00e3o completa, baseada em nuvem, para as conex\u00f5es de dados necess\u00e1rias para a conformidade com a DSCSA. Essa plataforma integra sistemas internos e externos de informa\u00e7\u00f5es de itens serializados, permitindo a rastreabilidade de ponta a ponta na cadeia de suprimentos. O UniTrace for Pharmacy permite que esse setor tamb\u00e9m esteja em conformidade, com conex\u00f5es e verifica\u00e7\u00f5es. A Systech pode ajudar as empresas a transformar a complexidade da cadeia de suprimentos em conectividade com rastreabilidade verdadeira e global.\u00a0<\/p>

<\/p>

\"Nossa tecnologia e experi\u00eancia visam garantir que as empresas n\u00e3o apenas atendam, mas tamb\u00e9m superem os requisitos da DSCSA, protegendo seus neg\u00f3cios, seus parceiros e os pacientes que todos trabalham para atender\", acrescenta Patnala.\u00a0\u00a0<\/p>

<\/p>

\u00c9 importante lembrar que os prazos n\u00e3o foram alterados e que o pr\u00f3ximo per\u00edodo de estabiliza\u00e7\u00e3o deve ser usado com sabedoria. Os fabricantes, atacadistas e distribuidores precisam verificar as conex\u00f5es de dados e garantir que seus processos de tratamento de exce\u00e7\u00f5es tenham sido testados adequadamente.\u00a0\u00a0<\/p>

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Contato com a m\u00eddia<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Systech PR<\/p>\n

(609) 395-8400<\/p>\n

pr@systechone.com<\/a><\/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\t\t<\/div>","protected":false},"excerpt":{"rendered":"

\u00c0 luz do recente an\u00fancio da FDA sobre um atraso na aplica\u00e7\u00e3o da Lei de Seguran\u00e7a da Cadeia de Suprimentos de Medicamentos (DSCSA), a Systech, parte da Markem-Imaje e da Dover, e fornecedora l\u00edder de solu\u00e7\u00f5es de software de identifica\u00e7\u00e3o digital e rastreabilidade, adverte o setor contra a complac\u00eancia.<\/p>","protected":false},"author":26,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[6],"tags":[],"class_list":["post-20411","post","type-post","status-publish","format-standard","hentry","category-announcements"],"acf":[],"yoast_head":"\nDSCSA compliance for pharma<\/title>\n<meta name=\"description\" content=\"DSCSA 2023 stabilization period is no excuse.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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