{"id":43,"date":"2014-06-26T13:01:30","date_gmt":"2014-06-26T18:01:30","guid":{"rendered":"http:\/\/grupodesisa.mx\/blog\/?p=43"},"modified":"2014-06-26T13:21:17","modified_gmt":"2014-06-26T18:21:17","slug":"software-para-la-industria-farmaceutica","status":"publish","type":"post","link":"https:\/\/grupodesisa.mx\/blog\/software-para-la-industria-farmaceutica\/","title":{"rendered":"Software para la industria farmac\u00e9utica"},"content":{"rendered":"

Hoy en d\u00eda, la industria farmac\u00e9utica M\u00e9xico, seg\u00fan Canifarma<\/a>, es uno de los principales mercados de insumos para la salud y por lo tanto, cada d\u00eda existe mayor competitividad entre las empresas farmac\u00e9uticas. Es por ello que contar con sistemas o software para la industria farmac\u00e9utica es de vital importancia. Sin embargo, es sabido que las farmac\u00e9uticas tienen est\u00e1ndares de calidad altos comparados contra otras industrias y el caso de los sistemas computarizados<\/strong>, no es la excepci\u00f3n.
\n<\/p>\n

As\u00ed que, sin duda, se deben automatizar la mayor cantidad de procesos que sea posible, pero hay algunos requisitos a considerar al momento de pensar en adquirir un sistema computarizado para farmac\u00e9uticas.<\/p>\n

\"Software<\/p>\n

La validaci\u00f3n de los sistemas computarizados<\/h2>\n

Los sistemas computarizados, no pueden comercializarse como sistemas “validados”, ya que de empresa a empresa, el tipo de informaci\u00f3n que se maneja y la infraestructura inform\u00e1tica varian ampliamente. Sin embargo, si se pude decir que un sistema computarizado es validable<\/strong>, si cumple con los requisitos inherentes al software, como lo son: tener un sistema de control de accesos a trav\u00e9s de firmas electr\u00f3nicas, un sistema de rastreabilidad de movimientos, entre otras cosas. La empresa farmac\u00e9utica que adquiera el software tendr\u00e1 que hacer su parte para que el sistema est\u00e9 validado.<\/p>\n

El CFR 21 parte 11 – Registros y firmas electr\u00f3nicas<\/h2>\n

Hay muchos tipos de registros electr\u00f3nicos en la industria farmac\u00e9utica. Desde los simples certificados generados, en ovaciones en Excel hasta datos provenientes del ERP. La NOM-059-SSA1-2013 en la secci\u00f3n 9.13 de la norma incluye los requisitos necesarios para validar sistemas computacionales que impacten la calidad de producto. El concepto de registros y firmas electr\u00f3nicas primeramente fue tomado del CFR 21 parte 11. Ahora es parte de la normatividad mexicana.<\/p>\n

En cuanto a las firmas electr\u00f3nicas, estas deben ser asignadas a una \u00fanica persona y no son transferibles. De ser as\u00ed, romper\u00edamos el esquema de la validaci\u00f3n. Se debe de definir documentalmente el alta de los usuarios en el sistema computarizado.<\/p>\n

Rastreabilidad de Movimientos (Audit Trail)<\/h2>\n

Como sabemos el seguimiento que se le da a la informaci\u00f3n es de vital importancia. Saber quien realiz\u00f3 la actividad, si est\u00e1 calificado para desempe\u00f1arla, el d\u00eda, la hora y lo que realiz\u00f3, debe ser registrado en cualquier software para la industria farmac\u00e9utica. Por lo tanto, esto debe ser revisado por el equipo que analice la adquisici\u00f3n del software.<\/p>\n

Respaldo y restauraci\u00f3n de la informaci\u00f3n<\/h2>\n

Otro punto importante a considerar es la oportunidad que brinde un software de respaldar la informaci\u00f3n que se est\u00e9 registrando. Esto debido a que si por alguna raz\u00f3n (virus inform\u00e1tico, da\u00f1o del hardware, incendio, etc.) la informaci\u00f3n se perdiera, es necesario tener una manera de recuperarla como si nada hubiese pasado.<\/p>\n

En conclusi\u00f3n. La adquisici\u00f3n de un software para la industria farmac\u00e9utica debe ser analizada cuidadosamente por un equipo calificado y se deben tomar en cuenta lo que la normatividad vigente indica.<\/p>\n","protected":false},"excerpt":{"rendered":"

Hoy en d\u00eda, la industria farmac\u00e9utica M\u00e9xico, seg\u00fan Canifarma, es uno de los principales mercados de insumos para la salud y por lo tanto, cada d\u00eda existe mayor competitividad entre las empresas farmac\u00e9uticas. Es por ello que contar con sistemas o software para la industria farmac\u00e9utica es de vital importancia. Sin embargo, es sabido que […]<\/p>\n","protected":false},"author":1,"featured_media":25,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-43","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-validacion-de-sistemas-computarizados"],"yoast_head":"\nSoftware para la industria farmac\u00e9utica<\/title>\n<meta name=\"description\" content=\"Cada d\u00eda existe mayor competitividad entre las farmac\u00e9uticas. 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