The 7 Best FDA Compliance Software of 2024

|Qualio|Greenlight Guru|Sparta Systems|SmartSolve

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.


  • 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.


  • 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.


  • 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.


  • 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.


  • 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.


  • 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.


  • Risk management
  • Audit management
  • CAPA management

What is FDA Compliance Software?

Compliance with the regulations of the Food and Drug Administration (FDA) is crucial for various industries. As long as your business is regulated by the FDA, it’s important that you ensure your agency’s operations are FDA-compliant. FDA compliance software is a program specifically designed to make it easier for organizations to abide by FDA standards and regulations.


It’s very important for relevant companies to ensure FDA compliance. Failure to follow FDA regulations can result in some hefty consequences for your organization. So, if you’re looking to avoid these consequences, make sure that you have a team and apply certain processes to ensure compliance.

That said, FDA compliance is very complicated. In fact, it can take a lot of time and resources. This is why organizations usually have such a hard time ensuring FDA compliance. However, if you have the right toolset, you can bring your FDA compliance processes to the next level.

When you have FDA compliance software, you can digitize your compliance processes. That way, it’s much easier to track and ensure compliance. On top of that, the right software allows you to save time and resources, making it much better for you and the organization.

Key Features

Since FDA compliance is very complicated, you need to make sure your software has all the necessary features. Every company has different feature needs for FDA compliance. However, some of the basic features that all FDA compliance software needs include:

  • Auditing and checklists
  • Building workflows
  • CAPA management
  • Risk management
  • Documentation
  • Mobile access
  • Training
  • Communication

Choosing the Right FDA Compliance Software

Since you need to make sure to find the best software for your company’s needs, it’s always best to compare the different options on the market. So, to make things easier for you, here’s a quick comparison of the options mentioned above.

App Name Free Version Paid Plan Mobile App
SafetyCulture Yes $24/user/month* Yes
MasterControl No Custom pricing Yes
Qualio No Contact for pricing No
Greenlight Guru No Custom pricing No
TrackWise No Contact for pricing Yes
ComplianceQuest No $30/month Yes
SmartSolve No Contact for pricing No

*billed annually

Leon Altomonte
Article by
Leon Altomonte
Leon Altomonte is a content contributor for SafetyCulture. He got into content writing while taking up a language degree and has written copy for various web pages and blogs. Aside from working as a freelance writer, Leon is also a musician who spends most of his free time playing gigs and at the studio.