{"id":14101,"date":"2023-05-20T08:31:08","date_gmt":"2023-05-20T08:31:08","guid":{"rendered":"https:\/\/www.siveco.com\/norma-21cfrpart11-e-cmms\/"},"modified":"2025-07-15T07:45:08","modified_gmt":"2025-07-15T07:45:08","slug":"norma-21cfrpart11-e-cmms","status":"publish","type":"post","link":"https:\/\/www.siveco.com\/pt-br\/blog-gmao\/norma-21cfrpart11-e-cmms\/","title":{"rendered":"Norma 21CFRPART11 e CMMS"},"content":{"rendered":"\t\t
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A FDA (Foods and Drugs Administration) exige que todos os fabricantes de produtos farmac\u00eauticos e aliment\u00edcios que desejam comercializar seus produtos nos Estados Unidos e, por extens\u00e3o, na Europa, cumpram a norma 21 CFR parte 11. As empresas dos setores mencionados acima que se equipam com uma solu\u00e7\u00e3o CMMS (Computer Aided Maintenance Management, gerenciamento de manuten\u00e7\u00e3o auxiliado por computador) precisam verificar se a solu\u00e7\u00e3o \u00e9 compat\u00edvel com a norma 21 CFR parte 11. <\/strong><\/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

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Mas aten\u00e7\u00e3o: n\u00e3o basta ter uma solu\u00e7\u00e3o que atenda \u00e0s expectativas da norma. As regulamenta\u00e7\u00f5es dos EUA v\u00e3o muito al\u00e9m, impondo in\u00fameras garantias sobre a integra\u00e7\u00e3o da solu\u00e7\u00e3o para atender aos crit\u00e9rios exigidos pela FDA.
21 CFR part 11 estabelece as disposi\u00e7\u00f5es regulamentares que todos os fabricantes devem cumprir para atender \u00e0 legisla\u00e7\u00e3o dos EUA sobre reten\u00e7\u00e3o de dados e assinaturas eletr\u00f4nicas. Essa norma certifica que a empresa est\u00e1 em conformidade com os crit\u00e9rios de seguran\u00e7a muito altos exigidos pela norma, o que reduz muito o risco de produtos fora de conformidade serem colocados no mercado. <\/p>\t\t\t\t\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

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Um padr\u00e3o que exige rastreabilidade em v\u00e1rios n\u00edveis\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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A palavra-chave associada ao padr\u00e3o \u00e9 rastreabilidade exaustiva. Deixe-me explicar: a empresa deve saber o tempo todo o que foi feito e por quem, com um sistema de identifica\u00e7\u00e3o muito avan\u00e7ado. Esse \u00e9 um dos primeiros requisitos para a conformidade com o CFR 21, parte 11. Para isso, a solu\u00e7\u00e3o escolhida deve permitir que voc\u00ea registre os tra\u00e7os deixados no sistema e os torne utiliz\u00e1veis e selecion\u00e1veis com um valor antes\/depois nos dados modificados. Eles devem poder ser usados de forma intelig\u00edvel e simples. As altera\u00e7\u00f5es que s\u00e3o marcadas pela solu\u00e7\u00e3o e as opera\u00e7\u00f5es registradas devem ser facilmente acess\u00edveis, por exemplo, por meio de uma fun\u00e7\u00e3o integrada \u00e0 ferramenta que n\u00e3o exija nenhuma habilidade de consulta. <\/p>

Depois de dominarmos o uso de dados, precisamos lidar com os circuitos transacionais. Para isso, o CMMS ter\u00e1 de oferecer um sistema de assinatura eletr\u00f4nica que permita a rastreabilidade passo a passo, com base no sistema de identifica\u00e7\u00e3o. <\/p>

Esse sistema precisar\u00e1 ser refor\u00e7ado por um gerenciamento de usu\u00e1rios mais detalhado, at\u00e9 o item de dados individual. Cada usu\u00e1rio s\u00f3 poder\u00e1 trabalhar na parte do processo que lhe foi atribu\u00edda (rastreabilidade do acesso aos dados). Da mesma forma, dentro de um processo, apenas determinados campos podem ser acess\u00edveis, dependendo do usu\u00e1rio, e sua exibi\u00e7\u00e3o ou uso pode at\u00e9 ser restrito, dependendo do valor do campo. Um mecanismo de desconex\u00e3o autom\u00e1tica ap\u00f3s um determinado per\u00edodo de tempo sem a\u00e7\u00e3o \u00e9 essencial. Obviamente, tudo o que deve ser respeitado na ferramenta tamb\u00e9m deve ser respeitado em suas ferramentas m\u00f3veis. <\/p>\t\t\t\t\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

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Implementa\u00e7\u00e3o, uma fase cr\u00edtica para a conformidade com os padr\u00f5es\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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O est\u00e1gio mais cr\u00edtico diz respeito \u00e0 implementa\u00e7\u00e3o da solu\u00e7\u00e3o. Ela deve ser realizada na presen\u00e7a do cliente (instala\u00e7\u00e3o a quatro m\u00e3os), pois \u00e9 o cliente que garantir\u00e1 a conformidade da instala\u00e7\u00e3o da solu\u00e7\u00e3o no caso de uma auditoria. A norma 21 CFR parte 11 exige uma metodologia comprovada nesse est\u00e1gio para garantir a qualidade da integra\u00e7\u00e3o da solu\u00e7\u00e3o. <\/p>

Em primeiro lugar, em termos de documenta\u00e7\u00e3o, o editor ter\u00e1 que fornecer documenta\u00e7\u00e3o exaustiva e compreens\u00edvel para o cliente, incluindo as altera\u00e7\u00f5es feitas no software, para que o cliente possa entender o impacto dessas altera\u00e7\u00f5es e verificar a conformidade quando o software for instalado pela primeira vez, bem como para quaisquer atualiza\u00e7\u00f5es.<\/p>

O editor pode ent\u00e3o trabalhar com o cliente para definir o n\u00famero de ambientes necess\u00e1rios para implementar o software (teste, produ\u00e7\u00e3o etc.) e a metodologia adaptada a essa arquitetura.<\/p>

Mais uma vez, a rastreabilidade das opera\u00e7\u00f5es ser\u00e1 essencial para garantir que cada a\u00e7\u00e3o executada em um ambiente seja reproduzida de forma id\u00eantica nos outros, especialmente no ambiente de produ\u00e7\u00e3o.<\/p>

Duas fases s\u00e3o essenciais: a QI (Qualifica\u00e7\u00e3o de Instala\u00e7\u00e3o), que fornece detalhes precisos da instala\u00e7\u00e3o a ser realizada para os diferentes ambientes, e a QO (Qualifica\u00e7\u00e3o Operacional), que garante que o software est\u00e1 em conformidade com as especifica\u00e7\u00f5es esperadas pelo cliente e que elas ser\u00e3o reproduz\u00edveis na produ\u00e7\u00e3o.<\/p>\t\t\t\t\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

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Uma escolha que n\u00e3o deve ser feita levianamente\n\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Diante dessa restri\u00e7\u00e3o normativa, os editores e integradores de software precisam, acima de tudo, apoiar seus clientes na implementa\u00e7\u00e3o de um sistema seguro e de alto desempenho que lhes permita aprimorar o gerenciamento da manuten\u00e7\u00e3o e, ao mesmo tempo, fornecer naturalmente os elementos exigidos pela norma durante as auditorias.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Entrevista com especialista – Laurent Cr\u00e9tot, diretor de vendas e marketing do Siveco Group.<\/strong><\/p>\t\t\t\t\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>\n\t\t","protected":false},"excerpt":{"rendered":"

A FDA (Foods and Drugs Administration) exige que todos os fabricantes de produtos farmac\u00eauticos e aliment\u00edcios que desejam comercializar seus produtos nos Estados Unidos e, por extens\u00e3o, na Europa, cumpram a norma 21 CFR parte 11. As empresas dos setores mencionados acima que se equipam com uma solu\u00e7\u00e3o CMMS (Computer Aided Maintenance Management, gerenciamento de […]<\/p>\n","protected":false},"author":3,"featured_media":10804,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[124],"tags":[],"class_list":["post-14101","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-opiniao-de-especialistas"],"yoast_head":"\nNorma 21CFRPART11 e CMMS - Siveco<\/title>\n<meta name=\"description\" content=\"A norma americana 21 CFR parte 11 define as expectativas de rastreabilidade dos fabricantes com rela\u00e7\u00e3o \u00e0s solu\u00e7\u00f5es CMMS.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.siveco.com\/pt-br\/blog-gmao\/norma-21cfrpart11-e-cmms\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Norma 21CFRPART11 e CMMS - 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