Using Open Source Tools in a 21CFR11 Regulated Environment R. Mark Adams, Variagenics, Inc.
Track: Bioinformatics Overview Date: Tuesday, February 04 Time: 5:00pm - 5:45pm Location: California Ballroom A & B
Open source tools have always been popular in bioinformatics, and are currently in widespread use in that environment. As the research products developed by biotechnology companies proceed closer to clinical development, the role of regulations, such as 21CFR11, in software development become important. Variagenics participates in a wide variety of clinical trials, both internally-sponsored and through partnerships. Adams dissects how Variagenics has used open source tools as part of the software development process supporting clinical trials activity, and goes into detail on the specific procedures and development protocols used.
