FDA‑Compliant in hours, not weeks Document Control Built for Innovators
QualiVault manages all aspects of FDA regulated document controls, allowing you to focus on what really matters - building your new technology.
Get Started!Everything You Need for FDA Compliance
Powerful features designed for modern life sciences companies
21 CFR Part 11 Compliant
Built-in compliance with FDA's electronic records and signatures regulation from day one.
Drag & Drop Upload
Intuitive document management with simple drag-and-drop functionality for easy file organization.
Smart Notifications
Automated alerts for approvals, deadlines, and compliance requirements to keep your team on track.
No Setup Fees
Transparent pricing with zero hidden costs - start using QualiVault immediately without upfront fees.
Pay-as-you-grow
Scalable pricing that grows with your business - only pay for what you need, when you need it.
Free Migration Support
Expert assistance to seamlessly migrate your existing documents and workflows to QualiVault.
The Problem with Legacy Tools
Complex Deployments
Most systems take weeks or even months to fully roll out, creating significant delays and inefficiencies.
Innovation-Stifling Processes
Validation is mandatory for any software tool used to comply with 21 CFR. Yet, most solutions offer minimal or no support.
High Setup Costs
Legacy solutions are designed for legacy businesses, with ambiguous pricing, partial solutions, and 5-figure contracts.
Frequently Asked Questions
What does the automated validation suite do?
Our automated validation suite handles the heavy lifting of ensuring your system meets FDA requirements. It performs checks and balances on document configurations, approvals, and workflows—giving you peace of mind while saving you valuable time and effort.
How secure is QualiVault in storing my sensitive documents?
Security is our top priority. QualiVault uses industry-leading encryption, secure data centers, and strict access controls to protect your files. You can rest assured that your documents remain safe and compliant at all times.
How often do you release updates to the software?
We regularly update QualiVault to improve performance, add new features, and stay aligned with regulatory requirements. Because of our innovation validation automation, we can roll out these updates to all users in real time, so you'll always have the latest and most secure version without any extra effort on your part.
Can QualiVault integrate with other tools and systems?
Yes! Just let us know what integration would benefit your team, and we will take care of the rest!