Design software for a spectrophotometer for 21 CFR Part 11 compliance



Hi Folks,

We build a spectroscopy instrument that has a software on a computer component to it. Recently Pharmaceutical companies have been interested in our instrument and would like to know if we can make it 21 CFR 11. I have read through the FDA website and comments on this website. However, I am unsure of what is general acceptable practices. We would like to work with a software developer (Java) that could provide us with some guidance or do the work of getting the necessary features and hooks into application.

Does anyone have recommendations of folks they have worked with before on something similar?

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