Tag: FDA

11 Ways Fishbowl Helps Companies Reach Strict FDA Compliance

Robert LockardApril 13, 2016Leave a Comment

Fishbowl gives companies the tools to become FDA compliant, Fishbowl BlogLast week I answered the question: Is Fishbowl FDA compliant? It turns out that that question is framed incorrectly because no software can claim to be FDA compliant. It’s up to businesses to use Fishbowl’s technical control features in a way that meets FDA compliance standards.

So the question becomes: What are the technical controls Fishbowl offers to allow companies to become FDA compliant? (more…)

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Is Fishbowl FDA Compliant?

Robert LockardApril 04, 2016Leave a Comment

Is Fishbowl FDA compliant? Fishbowl BlogIs Fishbowl FDA compliant? Or, more precisely, is Fishbowl compliant with Title 21 CFR Part 11 of the Code of Federal Regulations, which constitutes the Food and Drug Administration’s regulations over electronic records and signatures?

Quite a mouthful, I know.

This is a question we frequently hear from companies that manufacture medical devices, medicine, biotechnology, and other products that fall under the FDA’s influence.

While the question “Is Fishbowl FDA compliant?” is nice and simple, the answer is quite complex. The problem with trying to definitively answer yes or no is twofold: (more…)

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