Is 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:

1. It’s Impossible for Any Software to Claim to Be Part 11 Compliant Right Out of the Box

Part 11 demands that companies that fall under FDA regulations use audits, audit trails, system validations, electronic signatures, and documentation for any software that helps them collect and process data for the FDA. There is no turnkey solution that can automatically do all of this. It’s up to each company to set up the necessary procedural and administrative controls to be Part 11 compliant. All a software provider can claim is that it offers a solution containing the necessary technical features required to set up a compliant system.

2. It’s Up to Businesses to Properly Implement and Use the Software

The responsibility for making sure any software adheres to Part 11 requirements falls on the shoulders of the company using that software. As stated above, a vendor can offer all the features a company needs to be compliant, but it can’t force that company to do it, nor can it plan for every eventuality or customization that could be required to make it work precisely the way different kinds of businesses need it to work.

So the question “Is Fishbowl FDA compliant?” is actually a misnomer. The answer is neither yes nor no, but: Fishbowl has all of the appropriate technical controls in place to enable a company to become FDA compliant.

I’ll go into more detail on the technical controls Fishbowl offers to help with FDA compliance in next week’s blog post.