One of the things that interested me while working at Helicos Biosciences was that there was a very controlled (and seemingly "non-agile") process for designing and documenting the hardware used in the Heliscope (DNA Sequencer). The Heliscope is a "research device" and not a "medical device" so it did not need FDA approval. Still, both hardware and software for medical devices needs to have a highly documented risk-analysis and risk reduction process put in place. Either you (as my reader) or I (in the future) may need to work under such regulations. I'm told agile processes can co-exist in such an environment but I haven't yet researched the details of how that might work. This section will be a place where I'll explore these areas as I learn them.
This webcast discusses the impact that
risk management will have on your Part 11 compliance program,
and on how you can develop strategies to “justify and document”
risk assessment. It also presents an overview of the FDA’s new
“cGMP for the 21st Century” Initiative and how it impacts regulatory compliance for GMP and GLP-compliant organizations.
The webcast above is about two years old and some things have changed since then. Victoria does a good job during the webcast telling you where else you can look for information. Victoria has also created a compliance resources website at www.21cfrpart11.com. The website appears to have been back when she worked at Waters Corporation so some of the links on this website may be broken. Still it looks like a great starting point for research on understanding compliance for the food, pharma, biotech, and medical devices industries.
