5 industry-leading eQMS vendors in 2022

Finding the right eQMS vendor for your growing life sciences organization is easier said than done. With so many different solutions out there, it can be difficult to know which solution provider will deliver the most value for your unique startup.

While it's technically possible to meet regulatory requirements using paper-based methods, it's a difficult undertaking, to say the least. Paper-based systems sap productivity and force quality professionals to dedicate their time to non-value-add admin and upkeep tasks.

We've seen businesses make this mistake over and over again.

As an industry-leading eQMS vendor for growing life science organizations, thousands of companies have found a solutions partner in Qualio.

Of course, we're not the only eQMS vendor out there. While we think we're the perfect solution for many life science organizations, we aren't the best fit for everyone.

With that in mind, let's take a look at the best eQMS software options for your medical device, pharmaceutical, or biotech company to help you figure out which solution is best for your organization.

The 5 best eQMS vendors in 2022

Before selecting an eQMS partner, we recommend defining system requirements.

Aside from compliance and functionality, an ideal eQMS should be tailored to your company's size, including users and stakeholders to administer the software.

Additionally, the eQMS should align with your organization's unique goals.

1. SmartSolve

SmartSolve is an eQMS solution designed by Pilgrim, an IQVIA company. The company markets its solution as a comprehensive tool purpose-built for managing compliance, risk, quality, and the supply chain in the life sciences sector.

SmartSolve is built behind the ISO 9001 standard for quality management systems. As such, the software provides high-value workflows, document management procedures, and powerful process management tools.

This solution is designed for enterprise organizations that can commit significant budget toward product configuration and are prepared for a potentially lengthy implementation phase. Unfortunately, some users say that the solution is "cumbersome" or "not very intuitive" as some implementations exceeded the expected delivery time.

RELATED READING: How Much Does eQMS Software Cost?

2. Qualityze

This vendor offers two distinct eQMS products with the same name, designed for the life sciences industry and the manufacturing industry. This closed-loop quality system is unique in that it is built on the Salesforce platform.

Qualityze includes a full range of QMS features for managing documents, nonconformance issues, 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).

This solution is a viable option for organizations currently utilizing Salesforce. It's also relatively unique in that it supports PMDA and TGA requirements.

Moreover, user data indicates that Qualityze primarily serves mid-sized and enterprise organizations.

RELATED READING: The 8 Essential Functions of CAPA Quality Management Software

3. MasterControl

MasterControl's eQMS is well-known around the life sciences industry and it is among the most widely adopted solution in the vertical. Today, several major regulatory agencies and more than 1,000 enterprises partner with MasterControl.

This solution is designed to address compliance and quality management in product development, clinical trials, supplier management, regulatory risk management, manufacturing, and post-market surveillance.

MasterControl is suited for enterprises with large product portfolios. It may be right for your organization if you need a complex, highly configurable eQMS and can dedicate significant resources toward implementation and customization.

4. TrackWise

Sparta Systems' TrackWise platform is an eQMS software designed for those subject to GMP requirements.

TrackWise is a comprehensive eQMS solution designed to increase visibility and improve organizational efficiency in the marketplace. The solution integrates easily with complex software ecosystems, including integration with ER, CRM, laboratory information management (LIMS), and manufacturing execution systems (MES).

Organizations that seek a robust eQMS solution might consider partnering with TrackWise. The platform's potential for integration is a significant strength and a requirement, since TrackWise's features are not inherently sufficient to comply with ISO 13485 and other major regulatory requirements.

5. Qualio

Qualio serves the entire life sciences industry and is built with the specific needs of quality management teams in mind. An industry-leading eQMS, Qualio enables organizations to grow through all pillars of quality, including document control, training, design controls, risk management, change control, internal audit, and more.

Qualio offers closed-loop insight for continuous improvement and risk management, as well as robust features for automation to bring products to market quickly. Software features include document control, training, non-conformances, CAPA, audits, suppliers, complaints, and more.

Customers can access flexible, transparent pricing models designed to accommodate the needs of all organizations, from startup to enterprise.

Qualio customers enjoy the following features and benefits:

  • “Swift and positive response” from the Qualio staff and support team
  • Simple, powerful administration and metrics
  • Provides a “good overview” for quality leaders
  • Offers a comprehensive system for QMS, LMS, and EDMS
  • Strong user adoption and satisfaction reported by customers

To get started, we recommend requesting a free product demo.


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Qualio scales as your business grows

Take the pain out of your quality management, regulatory compliance and corrective and preventative actions with Qualio's cloud-based eQMS, which is highly flexible and designed for a variety of use cases.

However, there are several great solutions for life sciences organizations. The best eQMS for your company is one that's sized for your unique needs and goals.


As an immediate next step, we recommend downloading our free guide to learn about the questions you need to ask as you evaluate your eQMS options.

With this guide, you'll be able to confidently select the eQMS option that is tailored to your company's growth stage, fits your current budget and delivers the tools to help you comply with your industry-specific rules and regulations.