agile software development case studies
FDA de verificación y validación de software
Tema principal de hoy es el uso ágil en un contexto regulado por la FDA de dispositivos médicos. Suena como un imposible lo sé, pero la gente de Agiletek y Abbott presenta un caso de estudio muy interesante sobre cómo lo hicieron. Comenzaron con la presentación "la forma en que solía trabajar", destacando un ciclo de desarrollo de más edad de la Década de 1990 que había muy estrictamente definidas las fases dev, incluyendo un ciclo de 10-12 semanas de integración – ¡Menuda gracia! Cuando se decidió implementar ágiles en un proyecto más reciente que se separaron de su ciclo de 3-5 años dev en 6 iteraciones semana. Aquí eran los mayores obstáculos que encuentran para lograr lo siguiente:
- Documentación – que abordó este tema por adelantado. Hay la percepción de que la FDA quiere camiones de documentos de los fabricantes de dispositivos médicos. La realidad es que, de acuerdo con los presentadores, que no es el caso … la FDA quiere "suficiente" documentación que demuestre su proceso ("menos gravosa" de la FDA hablar). El área más grande, por supuesto, la documentación de los requisitos que se hizo a través de una matriz de capacidades.
- Requisitos – Esto requiere un cambio cultural importante. Se habló de los proyectos anteriores, con 14 fases de definición de requisitos meses … que aún no captura todo! Ahora, se dan cuenta de que es un mito que todos los req'ts se puede definir por adelantado, y como el caballero de Abbott declaró: "Sus requisitos son finales cuando el producto es retirado del mercado."
- href = "http://www.klocwork.com/solutions/fdaSoftwareValidation.asp"> Software de verificación y validación (V & V) – hicieron hincapié en un enfoque basado en riesgos. Ejecutar las inspecciones de código y revisiones en las áreas más críticas del código. Mantenga a sus necesidades y centrado de alto nivel para testers están poniendo a prueba las cosas importantes.
De todos modos, aquí están los resultados que encontraron en la modernización de su desarrollo con Agile: mayor visibilidad, menores costos (calendario previsto y la reducción del tamaño del equipo del 20-30%), producto de mayor calidad (disponibilidad de software de trabajo permite la continua V & V), y en general el proyecto tuvo un ritmo constante a lo más que codifica la integración loco o backend V & V caos.
La un aspecto importante de ágil que no fueron capaces de implementar es el componente de los usuarios. Esto se debe principalmente a las compañías de dispositivos limitaciones med tiene alrededor de "pre-comercialización" de sus productos.
En definitiva, un caso de estudio muy interesante. Interesaría saber donde nadie ha visto este hecho en un entorno altamente regulado. Firmando desde 2009 … Ágil se seguro que nos siguen en Twitter
About the Author
Todd Landry, a Senior Product Manager at Klocwork, he is a leading developer software quality tools and expert in peer code review.
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