Choosing the best eQMS software for 2025

January 2, 2025

Managing product and system quality in 2025 amid the promise of emerging technologies can feel a bit overwhelming. This can be especially true when faced with a tightening budget. Thankfully, the reality is that automating quality processes alone enables you to save you time and money, eliminating the need to maintain binders and the constant updating of spreadsheets. An eQMS solution improves operational efficiency and ultimately enables your company to, not only produce higher quality products, but also enjoy higher profit margins.

The right quality management system software (eQMS) provides a single, centralized framework that enables your business to efficiently address all of the tasks that go into maintaining quality standards and regulatory compliance - from document management to product design to seamless handling of quality events.

Choosing the best eQMS software in 2025 will depend on the complexity of your organization's operations, your budget and your immediate needs versus long-term goals. Other factors to consider include ease of use, regulatory compatibility and available customer support. 

In this article, we provide an overview of pertinent features to look for in eQMS software in 2025 and highlight some systems that get high marks. But first, let’s make sure you understand the basics of eQMS software.

eQMS software basics

An eQMS is an electronic quality management system that automates a business’ quality processes -- centralizing, connecting and tracking all quality operations. eQMS software is typically cloud-based, making it accessible anytime, anywhere. Some providers offer an on-premise solution as well. 

In practice, eQMS software unites multiple quality processes, even if they were originally created within several unconnected applications. It can integrate data from multiple locations, departments and people to streamline quality processes, ranging from document control to corrective and preventive actions to audit prep. 

Benefits of using eQMS software

Any organization striving to achieve ISO, FDA or other regulatory compliance, or simply wanting to improve efficiency for bottom-line success, will benefit from using eQMS software. It is amazing how many binders and spreadsheets contain quality and compliance information that could be centralized with real-time reporting capabilities.

In today’s highly regulated environment, eQMS software makes sense for many reasons, even beyond operations. An eQMS provides: 

Automatic audit prep

Documentation needed for regulatory compliance is automatically generated, tracked and stored throughout its lifecycle. Many eQMS software solutions have embedded processes for meeting regulatory standards. 

Better, easier document control 

Automating document control with eQMS software means no more paper logs or lost email approvals. Documents are centrally stored in one place, while changes and approvals are tracked by the software. 

Real-time data

An eQMS serves as a repository for the most up-to-date data surrounding your quality operations – from the status of corrective actions to supplier evaluations. With a centralized, automated system, the latest data is always at your fingertips, ensuring decisions are made based on current information.  

Competitive edge

With an eQMS, quality becomes ingrained in your operations and efficiencies are reached throughout your organization, allowing you to bring your products to market more quickly. Saving time and money can put you ahead of your competitors. 

How much does eQMS software cost?

eQMS software typically ranges from $2,000 per user, per year to hundreds of thousands of dollars per year for a highly customized solution. When choosing an eQMS, pay especially close attention to the following factors: 

• Cost per license 
• The number and type of licenses your organization requires  
• Scalability of the platform  
• The number of modules/applications included  
• The cost to add modules or features 
• Data limitations and costs 
• Implementation timing and costs 
• Training and support costs for current and future employees 
• Validation costs 
• Maintenance, subscription or other added fees 

Licensing: The most common license types are per-user and concurrent. Per-user licensing is just as it sounds -- one license per individual user. Some eQMS providers charge per user but offer pricing options based on functionality. For instance, if a user needs “read only” access, associated fees for that type of license will be lower. 

Concurrent licensing allows companies to have multiple users on one shared license. If a company purchases five concurrent licenses, then five of their employees can use the software at any given time. This pricing model minimizes costs and makes it easier to scale up quickly.

Applications included: Many eQMS software providers offer pricing plans that start with a base of capabilities and increase in cost as extra capabilities are added. Make sure your non-negotiable functions are part of the core applications provided in the plan you’re considering, and be aware of which applications are add-ons and at what cost.  

Data limitations: You’ll also want to consider how much data the platform is able to store for you or if there are costs associated with different levels of data storage. A platform with unlimited data storage is ideal, but many companies have maximum data or document limitations. 

Implementation and training: Be sure to find out if software implementation and training are included in costs or if they will be additional charges. Find out what kind of solutions are included in these services and at what cost. Sometimes training is free but limited, for instance, to on-line information libraries.  

Additional fees: Be sure to ask about any additional fees, such as annual subscription fees or charges for software updates. Some eQMS providers charge for customer support, for example. You’ll want to make sure you factor additional fees into your cost examination. 

Scalability: Consider whether the eQMS software you’re considering offers applications that you can grow into as you either master other applications or as your business evolves and grows. Will there be an extra cost down the road when you need those capabilities? 

Top things to look for in eQMS software in 2025

Common applications and features to look for in an eQMS: 

Document Control with Electronic Signatures

A document control system is a major component of any QMS. In the eQMS arena, look for a system that offers electronic approvals and signatures, auto archiving and built-in traceability. This is especially important for Life Sciences companies that are required to meet FDA 21 CFR Part 11 requirements.

Regulatory/Audit Management

eQMS software in 2025 should automatically schedule audits and notify you when due; should be able to audit against any regulatory standard; and should link directly to other quality processes, such as documents and corrective and preventive actions (CAPAs).  

Scalability

Look for an eQMS that offers the ability to grow within the platform. While you’ll likely need document control from the start, other functions, such as automating supplier management, might be something you don’t currently need but can foresee being an asset as your business evolves. Keeping your data centralized in one platform can have reporting benefits that make it easier to make calculated decisions.

Cost Effectiveness

There are many pricing models used by the various eQMS software providers. Make sure your non-negotiable functions are part of the core applications provided, and be aware of which applications are add-ons and at what cost. You’ll also need to consider number of users and type of access. 

Out-of-the-Box Capabilities

Many eQMS providers offer customization, which takes costs to a whole new level. Out-of-the-Box eQMS solutions can provide robust capabilities for less and generally mean quicker implementation.

Comprehensive Support

As with any new software, there will likely be a learning curve. Look for an eQMS provider that will be there when you need help, whether its onboarding, software updates, over-the-phone support or a library of published instructions. 

Automations

eQMS software saves an organization time and money through integrations that eliminate repetitive, manual tasks and help operations stay on track. eQMS capabilities, such as real-time data updates across applications, auto-assignment of tasks, compliance tracking and electronic notifications, enable companies to more easily share information for improved collaboration and more impactful business decisions.

Validation

Organizations focused on life sciences, medical devices and pharmaceutical products should consider using validated QMS. Validated systems ensure that the software is in line with requirements set forth in FDA 21 CFR Part 11 and Part 820. Using a pre-validated QMS gives life sciences companies upfront knowledge that this requirement is already complete.