What's the best eQMS software in 2023? [Top 5 options]

    An electronic quality management system (eQMS) doesn’t just make life easier for quality teams. As the life science world gets increasingly competitive, regulated and scrutinized, the right QMS software can make the difference between success and failure.

    QMS software is an investment in your life sciences company's innovation, supporting the design of compliant products that exceed customer expectations. So how do you determine the right eQMS for you you?

    Selecting an eQMS requires careful consideration - not only the features, but also the user experience, training and the platform’s ability to grow with your business.

    To help your search, we've compiled a list of the top 5 eQMS systems available to life sciences companies in 2023.

    Table of Contents

    1. What is an eQMS?
    2. Best eQMS options
      1. Qualio
      2. MasterControl
      3. Pilgrim
      4. Qualityze
      5. Trackwise
    3. Choosing the best eQMS for you

    What is an eQMS?

    An eQMS is an electronic quality management system that enables quality teams to centrally manage and monitor their compliance processes. It helps life science companies create, maintain and report on key quality data elements throughout the product lifecycle. Features like document management, training management and non-conformance tracking are just a few of the capabilities offered in an eQMS system.

    Quality management software is the modern, digitized method for structuring and running a quality management system (QMS).

    The primary benefit of an effective eQMS it that it assists you in automating the key, traditionally manual business processes connected to quality, compliance and product development.


    In particular, businesses turn from a QMS to an eQMS to:

    • Move away from paper and spreadsheets
    • Connect employees to a single source of quality truth
    • Save money with efficient digital quality practices

    eqms software benefits
    Choosing quality management software

    Most eQMS software is designed with a particular business type, size or shape in mind. Some offer specific value for life science companies, while others are favored by food and manufacturing businesses. A global pharmaceutical brand with an extensive product portfolio will have different eQMS needs than a medical device startup focused on getting to market. 

    Choosing software designed specifically for organizations like your own will translate to faster implementation, stronger adoption, and swifter time to value. For highly regulated companies in sectors like life science, choosing an eQMS comes with a lot of functionality considerationsTypical eQMS features include:

    • Document management
    • Design controls (for medical device companies)
    • Risk management
    • Training management
    • Audit management
    • Corrective and preventive action (CAPA) management
    • Supplier management

    On top of this core functionality, you should consider niche features and services that could be critical to your business, such as:

    • Compliance with industry standards, like ALCOA+ or the FDA's 21 CFR Part 11 e-signature requirements
    • Customer support that fits your needs
    • Cloud-based access for a remote post-COVID world
    • Validation: how quick and easy is it with each vendor?

    12 questions to ask before you buy an eQMS

    Your eQMS should be targeted appropriately to your organization’s growth stage, budget, structure and industry. Choosing an eQMS that doesn't streamline efficiently or fit your use case can lead to wasted cost, non-compliance, or costly software bloat from overly extensive configurations. 

    We don't want that to happen to you. Dive into our recommendations of the top 5 eQMS providers on the market:

    5 best eQMS options

    1. Qualio


    Qualio eqms

    Our eQMS is designed to help small- to medium-sized life science companies scale and bring their products to market.

    Qualio is ideal for startups facing the world's tightest regulatory requirements, from FDA and ISO demands to GxP, and is built to do 3 things especially well: 

    1. Increase revenue through improved velocity to market
    2. To slice the total cost of quality
    3. To mitigate risk with improved quality processes

    Qualio's eQMS features include:

    Best for: Small- to mid-market organizations with aggressive growth goals that want an affordable eQMS system for comprehensive quality management and compliance.

    Qualio is the only eQMS designed specifically for startups, small to mid-size business, and life sciences companies in the scale phase, incorporating FDA, cGMP and ISO requirements as standard for pharma, biotech and medical device manufacturers.

    And we're proud of our diverse customer base stretching from America to Europe including the UK, Ireland, Sweden, Denmark, Switzerland, Norway, Belgium, Israel, Australia, New Zealand, USA and Canada.


    Vendor hunting tip

    You may be thinking: this is Qualio's website, of course they'd put themselves #1! This kind of caution and awareness of bias is important as you hunt for an eQMS vendor. To remedy bias, always look at customer reviews to see if a prospective vendor is really doing what they say they can do.



    • High customer satisfaction 
    • High-touch customer success support
    • Extra Qualio+ quality and regulatory for businesses with limited quality resource 
    • Simple, powerful UX and usability
    • Only eQMS with complete in-app document editing, powered by an intuitive document editor - no more flitting between Office and your quality system!
    • Cloud-based 
    • Rapid set-up and validation timeframes
    • Integration with other business tools like Jira and Salesforce


    • One user reported challenges importing complex database schema
    • No ERP integrations yet
    • Not designed for extensive lengthy customization 
    • US and EMEA footprint, limited presence elsewhere


    2. MasterControl

    Mastercontrol eQMSImage source: g2.com

    This eQMS is a well-known brand in the life sciences industry and among the most widely adopted eQMS systems in the vertical. Current users include several major regulatory agencies and 1,000 enterprises in 30 countries.

    MasterControl's eQMS functionality is designed to address compliance and quality management in product development, clinical trials, supplier management, regulatory risk management, manufacturing and post-market use cases.

    Best for: MasterControl is positioned as an enterprise eQMS for global enterprises with a large portfolio that spans the product development lifecycle. It may be right for your organization if you need a complex, highly configurable QMS software and can dedicate significant resources toward implementation and customization.


    • High connectivity between modules and processes
    • Robust features for collaboration and administration
    • Users report satisfaction with efficient document management features
    • The newly designed user interface is accessible and intuitive


    • Pricing is described as expensive and inflexible by adopters
    • Reported issues with system and search speed
    • Only offers exact match search functionality
    • The web app is only compatible with Internet Explorer
    • Challenging usability


    3. Pilgrim


    SmartSolve eqms

    SmartSolve is an eQMS software by Pilgrim, an IQVIA company that is marketed as a comprehensive solution for managing compliance, risk, quality and the supplier chain in the life sciences sector. Their QMS software is built under the ISO 9001 standard for quality management systems and provides workflows, document management, and process management.

    Their quality management system software can be cloud-based or installed on-premise. Additional capabilities include features and tools for electronic signatures, audits, analytics, and validation.

    Best for: Enterprise organizations that can commit significant budget towards product configuration and don't need rapid implementation of their eQMS.

    According to the vendor, current clients include some of the largest enterprises in the life sciences sector. Cited industries of focus include pharma, medical devices, combination products, and blood and tissue service organizations.


    • Varied functionality applications
    • Change management support and efficient document updates
    • Clear and organized documentation management
    • Administrative dashboards and project management features


    • Limited customer reviews available
    • Lacks built-in support for SMB organizational structures and workflows
    • Adopters report limited vendor resources for client education
    • Slow response to bug reports and client support requests
    • Some users say the solution is cumbersome or not very intuitive
    • Implementations exceeded the expected delivery time for some adopters


    4. Qualityze


    Qualityze eqms
    This vendor offers two distinct eQMS products with the same name, designed for the life science and manufacturing industries respectively.

    This closed-loop software includes a full range of eQMS features for managing documents, non-conformances, customer complaints, suppliers, audits and other activities required to comply with FDA cGMP, ISO 13485, Pharmaceuticals and Medical Devices Agency (PMDA), and Therapeutic Goods Administration (TGA) demands.

    Best for: Organizations using Salesforce or that have on-site Salesforce experts. It’s also relatively unique in support of PMDA and TGA requirements. User-provided data on software review source G2 indicates Qualityze’s customer base comprises primarily mid-sized and enterprise organizations.


    • eQMS Built on Salesforce
    • Out-of-the-box functionality
    • Intuitive user experience
    • Supports the roll-out of modules based on need


    • Limited user reviews compared to other solutions
    • One user reported they’d like to see more customization
    • Not compatible with Google Drive
    • Users report a high cost to performance ratio


    5. TrackWise


    TrackWise eqms

    Sparta Systems’ TrackWise product is an eQMS software platform designed for organizations subject to GMP requirements. The vendor positions the product as a comprehensive eQMS solution designed to increase visibility and improve organizational efficiency in a competitive market.

    The system offers the potential to integrate into a complex software ecosystem at enterprise organizations, including real-time integration with ERP, CRM, laboratory information management (LIMS), and manufacturing execution system (MES) applications. 

    Best for: Organizations seeking a robust solution for enterprise quality management should consider TrackWise. G2 user-reported data indicates the majority of TrackWise adopters are very large organizations. TrackWise’s potential for integration is a significant strength, but also a necessity for highly regulated businesses: the software’s features are not sufficient on their own to embed compliance with ISO 13485 and other life science standards.


    • Wide range of workflows and modules
    • Scalable and designed for multi-site implementations
    • Extremely flexible system supports extensive customization


    • Does not include archiving or retention features
    • Does not include controls testing
    • High training barrier, confusion, and functionality issues reported by users
    • User experience is not very intuitive


    Choosing the best eQMS 

    Thanks to the growing life sciences industry, eQMS options are growing rapidly. Don't settle for an eQMS that’s not purpose-built for your industry, exceeds your budget, or demands extensive configuration.

    When it comes to finally choosing the best eQMS for you, double and triple check the key factors of user-friendliness, scalability, industry compliance and cost. Additionally, make sure you understand what type of support the system offers and how often it's updated.

    By doing your research and making an informed decision, you can make sure that you choose an eQMS system that best fits your company’s needs for the long-term.

    Today, the market offers eQMS systems that are flexible, cloud-based, and more cost effective. The best eQMS for your company is the one that most closely aligns with your product and team specific goals and help you reach your next phase of growth.

    Want to start your search right now? We can show you around Qualio ASAP.