MasterControl

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Qualio

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What is the Best eQMS Software for 2024?

January 25, 2024

The best eQMS software for 2024 will make your business more efficient, saving you time and money by managing the details and letting you focus on the big picture. Choosing the best eQMS software will depend on the complexity of your operations, your budget and your immediate needs versus long-term goals.  You’ll also want to consider regulatory compatibility, customer care and ease of use.  

To make your search a bit easier, we’ve provided an overview of what to look for in an eQMS and highlighting a few solutions we think stand out from the crowd. 

What is eQMS software?

An eQMS is an electronic Quality Management System that automates your quality processes, centralizing, connecting and tracking your quality operations. eQMS software is typically cloud-based, making it accessible anytime, anywhere. Some companies offer an on-premise solution as well. 

In practice, eQMS software unites multiple quality processes that may have been originally created within several different applications. It easily connects data from multiple locations, departments and people to streamline quality control processes, from document control to corrective and preventive actions and employee training. 

Why would you need an eQMS?

If you’re striving to achieve ISO, FDA or other regulatory compliance, or if you just want to improve efficiency for overall performance and bottom-line success, an eQMS is the best way to automate compliance processes. In today’s day and age, an eQMS makes sense for a wide variety of reasons, even beyond operations. 

Some of the best arguments for an eQMS: 

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 via the software application. 

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.  

Stay ahead of competitors: 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 far 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 an individual user. Some eQMS software 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 licensing code. If a company purchases five concurrent licenses, then five of their employees can use the software at any given time. 

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 presented costs or if they will be additional charges. Find out what kind of services 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 software 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 2024

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. 

Regulatory/Audit Management

eQMS software in 2024 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. 

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. 

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 taken care of.