{"id":4631,"date":"2010-09-10T11:42:11","date_gmt":"2010-09-10T10:42:11","guid":{"rendered":"http:\/\/catai.net\/blog\/\/?p=4631"},"modified":"2010-09-10T11:44:12","modified_gmt":"2010-09-10T10:44:12","slug":"criterio-calidad-sofware","status":"publish","type":"post","link":"https:\/\/catai.net\/blog\/2010\/09\/criterio-calidad-sofware\/","title":{"rendered":"Criterio calidad sofware"},"content":{"rendered":"<p>De acuerdo con <a href=\"http:\/\/www.scientificcomputing.com\/Version-5-of-Good-Automated-Manufacturing-Practice-GAMP-Released-to-Public.aspx\">GAMP<\/a>&#8211; Good automated manufacturing Practice , las principales modificaciones de su version 4 a la version 5 de Marzo del 2008 estan especificadas en la tabla siguiente:<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone\" src=\"http:\/\/www.scientificcomputing.com\/uploadedImages\/Images\/newsletter\/sc8n601b_lrg.jpg\" alt=\"\" width=\"713\" height=\"416\" \/><\/p>\n<p><strong>La CATEGORIA-1<\/strong> sufrio un gran cambio pasando de sistemas operativos a infraestructura de software separada en varias areas:<\/p>\n<p>\u2022 <strong>Sofware comercial por capas:<\/strong> Que incluye la antigua categoria 1, pero tambien las bases de datos, los lenguajes de programacion, el middleware, los interpretes, los programas estadisticos y las hojas de calculo. Estos son productos basicos sobre los que corren las aplicaciones. Esto hace que por ejemplo las macros o los &#8220;templates&#8221; de Excel requieren VALIDACION previa. Cualquier\u00a0aplicaci\u00f3n\u00a0desarrollada con estos paquetes se excluyen de la categoria 1 y se convierten en Categoria 4 o 5.<br \/>\n\u2022 <strong>Herramientas de Infraestructura de Software:<\/strong> Incluye el software de gestion de red, anti-virus y herramientas de configuracion o cualquier software de red. Esencialmente todas estas aplicaciones se controlan (qualifican) en el momento de la instalacion ( \u00bfFunciona o no funciona?)<\/p>\n<p>La CATEGORIA-3 se define como &#8220;Software estandar&#8221; o no configurable para diferenciarlo claramente de la CATEGORIA-4. \u00a0De hecho el mismo software puede ser de Categoria 3 o 4 segun si se use con la configuracion de fabrica o se re-configure.<\/p>\n<p>Esta version en mas flexible para las CSV o computerized  system validation. Por ejemplo cada categoria de software 3,4 o 5 tiene su propio modelo de ciclo de vida y su\u00a0documentaci\u00f3n.<\/p>\n<p>Cuando se genere la version\u00a0GAMP 6 habra muy probablemente una introduccion general a los principios de validacion CSV y se separaran las aplicaciones y los procesos ya que no todas pueden tratarse por igual. En resumen, debera haber una revolucion en los sistemas de validacion de software que logicamente incidiran muy directamente en el control de calidad de las aplicaciones de telemedicina y salud electronica como puede analizarse en el <a href=\"https:\/\/catai.net\/blog\/\/2010\/05\/cmm-sw-en-aparatos-medicos\/\">CMM<\/a> o Capability Maturity Model.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>De acuerdo con GAMP&#8211; Good automated manufacturing Practice , las principales modificaciones de su version 4 a la version 5 de Marzo del 2008 estan especificadas en la tabla siguiente: La CATEGORIA-1 sufrio un gran cambio pasando de sistemas operativos a infraestructura de software separada en varias areas: \u2022 Sofware comercial por capas: Que incluye [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"give_campaign_id":0,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_hide_featured_image":false,"_jetpack_featured_image_duplicate_dismissed":0,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[3,38,28,29,32],"tags":[],"class_list":["post-4631","post","type-post","status-publish","format-standard","hentry","category-informes","category-contratacion-externa","category-sanidad","category-seguridad","category-sociedad_red"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Criterio calidad sofware | Telemedicina<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/catai.net\/blog\/2010\/09\/criterio-calidad-sofware\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Criterio calidad sofware | Telemedicina\" \/>\n<meta property=\"og:description\" content=\"De acuerdo con GAMP&#8211; Good automated manufacturing Practice , las principales modificaciones de su version 4 a la version 5 de Marzo del 2008 estan especificadas en la tabla siguiente: La CATEGORIA-1 sufrio un gran cambio pasando de sistemas operativos a infraestructura de software separada en varias areas: \u2022 Sofware comercial por capas: Que incluye [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/catai.net\/blog\/2010\/09\/criterio-calidad-sofware\/\" \/>\n<meta property=\"og:site_name\" content=\"Telemedicina\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/unesco.telemedicine\" \/>\n<meta property=\"article:published_time\" content=\"2010-09-10T10:42:11+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2010-09-10T10:44:12+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/www.scientificcomputing.com\/uploadedImages\/Images\/newsletter\/sc8n601b_lrg.jpg\" \/>\n<meta name=\"author\" content=\"Catai Blog Telemedicina\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@UnescoTeleMed\" \/>\n<meta name=\"twitter:site\" content=\"@UnescoTeleMed\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Catai Blog Telemedicina\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/catai.net\\\/blog\\\/2010\\\/09\\\/criterio-calidad-sofware\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/catai.net\\\/blog\\\/2010\\\/09\\\/criterio-calidad-sofware\\\/\"},\"author\":{\"name\":\"Catai Blog Telemedicina\",\"@id\":\"https:\\\/\\\/catai.net\\\/blog\\\/#\\\/schema\\\/person\\\/b30eb34cb987e56fbcab4d73f43176b9\"},\"headline\":\"Criterio calidad sofware\",\"datePublished\":\"2010-09-10T10:42:11+00:00\",\"dateModified\":\"2010-09-10T10:44:12+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/catai.net\\\/blog\\\/2010\\\/09\\\/criterio-calidad-sofware\\\/\"},\"wordCount\":304,\"commentCount\":0,\"image\":{\"@id\":\"https:\\\/\\\/catai.net\\\/blog\\\/2010\\\/09\\\/criterio-calidad-sofware\\\/#primaryimage\"},\"thumbnailUrl\":\"http:\\\/\\\/www.scientificcomputing.com\\\/uploadedImages\\\/Images\\\/newsletter\\\/sc8n601b_lrg.jpg\",\"articleSection\":[\"Informes\",\"Outsourcing\",\"Sanidad\",\"Seguridad\",\"Sociedad Red\"],\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/catai.net\\\/blog\\\/2010\\\/09\\\/criterio-calidad-sofware\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/catai.net\\\/blog\\\/2010\\\/09\\\/criterio-calidad-sofware\\\/\",\"url\":\"https:\\\/\\\/catai.net\\\/blog\\\/2010\\\/09\\\/criterio-calidad-sofware\\\/\",\"name\":\"Criterio calidad sofware | Telemedicina\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/catai.net\\\/blog\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/catai.net\\\/blog\\\/2010\\\/09\\\/criterio-calidad-sofware\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/catai.net\\\/blog\\\/2010\\\/09\\\/criterio-calidad-sofware\\\/#primaryimage\"},\"thumbnailUrl\":\"http:\\\/\\\/www.scientificcomputing.com\\\/uploadedImages\\\/Images\\\/newsletter\\\/sc8n601b_lrg.jpg\",\"datePublished\":\"2010-09-10T10:42:11+00:00\",\"dateModified\":\"2010-09-10T10:44:12+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/catai.net\\\/blog\\\/#\\\/schema\\\/person\\\/b30eb34cb987e56fbcab4d73f43176b9\"},\"breadcrumb\":{\"@id\":\"https:\\\/\\\/catai.net\\\/blog\\\/2010\\\/09\\\/criterio-calidad-sofware\\\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/catai.net\\\/blog\\\/2010\\\/09\\\/criterio-calidad-sofware\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/catai.net\\\/blog\\\/2010\\\/09\\\/criterio-calidad-sofware\\\/#primaryimage\",\"url\":\"http:\\\/\\\/www.scientificcomputing.com\\\/uploadedImages\\\/Images\\\/newsletter\\\/sc8n601b_lrg.jpg\",\"contentUrl\":\"http:\\\/\\\/www.scientificcomputing.com\\\/uploadedImages\\\/Images\\\/newsletter\\\/sc8n601b_lrg.jpg\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/catai.net\\\/blog\\\/2010\\\/09\\\/criterio-calidad-sofware\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Portada\",\"item\":\"https:\\\/\\\/catai.net\\\/blog\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Criterio calidad sofware\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/catai.net\\\/blog\\\/#website\",\"url\":\"https:\\\/\\\/catai.net\\\/blog\\\/\",\"name\":\"Telemedicina\",\"description\":\"Catedra UNESCO 1999-2017. 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