The 7 Best FDA Compliance Software of 2025

Why use SafetyCulture?

SafetyCulture is a great option for any organization in need of FDA compliance software. The program offers various features, all of which can help streamline your compliance processes. To start, you can use SafetyCulture’s various inspection checklists to make sure your audits cover all bases for FDA compliance. On top of that, the app allows you to easily communicate with team members and keep everyone organized. That way, it takes much time and effort to comply with relevant FDA regulations.

Features:

• Conduct inspections and audits with the use of FDA compliance checklists

• Report compliance issues right away and assign actions to correct them

• Communicate updates from the FDA with the entire organization through Heads Up

• Build workflows that comply with FDA regulations

• Train employees in FDA-compliant practices to create a solid compliance culture in the organization

Why use MasterControl?

MasterControl gives you complete control of your documents. Document management is an essential part of maintaining compliance in your organization. With MasterControl, the entire process is easier as you can quickly store and access all the documents you need on the software.

Features:

• Document management

• Risk management

• Training management

Why use Qualio?

Qualio is great for FDA compliance as it’s a software solution specifically designed for eQMS. While designed for life science companies, the software is very useful for just about any company that complies with FDA regulations. The app allows you to control documents, train employees in your practices, and streamline the entire compliance process for the team.

Features:

• Training management

• Audit management

• E-signatures and approvals

Why use Greenlight Guru?

Greenlight Guru is a software program specifically designed for companies that sell medical devices. If you sell medical devices, you must comply with all the relevant FDA regulations. With Greenlight Guru, compliance management is much easier as the app gives you full control of all your processes, from risk management to CAPAs.

Features:

• CAPA management

• Change management

• FDA and ISO compliance

Why use TrackWise?

Sparta Systems offers a wide range of different solutions for businesses in the medical industry. So, it comes with some solutions specifically for FDA compliance. For example, their TrackWise solution allows you to manage complaints, documents, and even training, making FDA compliance a breeze.

Features:

• Training management

• Audit management

• Complaint management

Why use ComplianceQuest?

As the name suggests, this software was specifically made for quality management. This is why you can expect a range of great features that can help you maintain your FDA compliance. The app can help you track events, defects, suppliers, and even documents. So, if you’re looking to streamline FDA compliance in your organization, this is a great pick.

Features:

• Defect management

• Supplier management

• Document management

Why use SmartSolve?

SmartSolve offers a wide range of EHS solutions for modern companies. This includes various tools for FDA compliance. There are many SmartSolve features that can make FDA compliance much easier, from CAPA management and audit management all the way to risk and supplier management.

Features:

• Risk management

• Audit management

• CAPA management