Comentarios (2)

1 bobnadler ha hecho un comentario el Enlace permanente

21 CFR Part 11 deals with authentication and auditing of electronic records and is mostly used in the pharma industry. It is not a "life-critical regulation". You're thinking of medical device development which is regulated by the FDA QSRs (Part 820). For more information see: <div>&nbsp;</div> <a href="http://rdn-consulting.com/blog/2007/07/22/agile-development-in-a-fda-regulated-setting/">Agile development in a FDA regulated setting</a>

2 ScottAmbler ha hecho un comentario el Enlace permanente

Thanks. I just updated accordingly.

Añadir un comentario Añadir un comentario