Is Your Web Survey Tool Compliant with FDA Standards?

When collecting data for clinical trials, pharmaceuticals, or healthcare-related studies, compliance with regulatory standards is essential. One often overlooked area is how survey tools handle sensitive or regulated information. If your organization gathers data electronically, especially in research or FDA-regulated environments, it’s crucial to ensure your software aligns with the appropriate legal requirements.

One such regulation is web survey software FDA 21 CFR Part 11, which outlines how electronic records and signatures must be managed to be considered trustworthy and equivalent to paper records. This includes audit trails, secure user access, data integrity, and proper validation of systems. Using a web survey platform that lacks these features can put your data — and your organization — at risk.

It's not just about ticking a compliance checkbox. It’s about protecting participant data, ensuring reproducibility of results, and building trust with regulatory bodies. From login security to time-stamped audit logs, every technical and procedural control matters.

Before launching your next digital survey in a regulated context, ask yourself: does your tool support role-based access control? Can it verify data has not been tampered with? Are electronic signatures securely linked to their records?

These questions can make the difference between a smooth approval process and regulatory delays. Choosing the right software isn’t just a technical decision — it’s a compliance strategy.