Nov 12, 2020 Robert Fenton

The Best QMS Software: The Pros and Cons of the 5 Top Options

A Quality Management System (QMS) is a critical investment life sciences companies cannot ignore.

Revenue-boosting benefits of QMS software include better consistency, minimized rework, happier customers, and better brand valuation and positioning.

Achieving a quality-driven culture enables your organization to reduce unnecessary quality costs and regulatory risks, which means bringing better products to market faster.

However, to save time, money, and resources with QMS software, you need to choose the solution that fits your organization's needs. An electronic QMS (eQMS) should be right-sized to your organization's growth stage, budget, structure, and industry. Trying to adopt a QMS that doesn't fit your use case can lead to wasted cost, non-compliance, or costly software bloat from overly extensive configurations.

How do you know which QMS software can quickly provide a return on investment?

Choosing The Best QMS Software For Your Life Sciences Organization

In years past, QMS solutions were primarily homegrown solutions designed specifically for the needs of an enterprise. "QMS adoption" was an incredibly costly and complicated venture which required years of effort to gather requirements, develop the software, and roll it out across the organization.

Today's organizations have the benefit of selecting from an extensive range of cloud-based solutions for quality management, including software-as-a-service (SaaS) solutions designed specifically for their industry. The best QMS software is designed to offer deep value for specific business scenarios, such as global enterprises with an extensive product portfolio or startups focused on research and development.

Yesterday’s homegrown QMS deployments are officially a thing of the past. Gartner predicts that by the end of 2019, the enterprise software landscape will “devolve into purpose-built cloud-based content solutions and solution services applications,” says research Vice President Craig Roth. Choosing a software designed specifically for organizations like your own can translate to faster implementations, stronger adoption, and faster time-to-value.

1. Pilgrim

SmartSolve is a QMS software solution by Pilgrim, an IQVIA company which is marketed as a comprehensive solution for managing compliance, risk, quality, and the supplier chain in the life sciences sector. The software is built under the ISO 9001 standard for quality management systems and provides workflows, document management, and process management. Additional capabilities include features and tools for electronic signatures, audits, analytics, and validation.

The Best Fit:

Pilgrim is designed for enterprise organizations who can commit significant budget towards product configuration and are prepared for a potentially lengthy implementation phase. According to the vendor, current clients of this software 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.


  • “Extreme” amount of functionality
  • Change management support and efficient document updates
  • “Clear and organized” documentation
  • Administrative dashboards and project management features


  • Lacks built-in support for SMB organizational structures and workflows
  • Adopters report limited vendor resources for client education
  • Reported slow vendor 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


Prospective customers are encouraged to complete a Pilgrim web form to request a call with a sales representative.

RELATED READING: How Much Does eQMS Software Cost?

2. Qualityze

This vendor offers two distinct QMS 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. Qualitize includes a full range of QMS features for managing documents, nonconformances, 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).

The Best Fit:

This solution may be a viable choice for organizations that are using Salesforce or have on-site Salesforce experts. It’s also relatively unique in support for PMDA and TGA requirements. User-provided data on software review source G2 Crowd indicates Qualityze’s customer base includes primarily mid-sized and enterprise organizations.


  • Built on Salesforce
  • Offers out-of-the-box functionality
  • Intuitive user experience
  • Supports the roll-out of modules based on need
  • Users report a high value for the cost



A web form is provided on the vendor website to schedule a demo and receive a 1-week free product trial. New call-to-action

3. Trackwise

Sparta Systems' TrackWise product is a QMS software designed for organizations that are subject to GMP requirements. The vendor positions the product as a comprehensive QMS solution designed to increase visibility and improve organizational efficiency in a competitive market. The solution offers the potential to integrate into a complex software ecosystem at enterprise organizations, including integration with ERP, CRM, laboratory information management (LIMS), and manufacturing execution system (MES) applications. TrackWise can integrate with your ERP, CRM, LIMS, and MES systems. Ensure real-time interoperability among all your enterprise systems.

The Best Fit:

Organizations who are seeking a robust solution for enterprise QMS may consider Trackwise. G2 Crowd user-reported data indicates the majority of Trackwise adopters are at very large organizations. Trackwise's potential for integration is a significant strength and a requirement since the software's features are not inherently sufficient to comply with ISO 13485 and other regulatory requirements.


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


  • Does not include archiving or retention features
  • Does not include controls testing
  • Is not ISO compliant
  • "High training barrier," confusion, and functionality issues reported by users


Demos are offered and can be requested by filling out a form on the Sparta Systems website.

RELATED READING: 6 Essential Qualities of the Best eQMS Systems

4. Mastercontrol

This QMS is a well-known brand in the life sciences industry, and among the most widely adopted solutions in the vertical. Current users include several major regulatory agencies and 1,000 enterprises in 30 countries. Solutions offered within MasterControl are designed to address compliance and quality management in product development, clinical trials, supplier management, regulatory risk management, manufacturing, and post-market use cases.

The Best Fit:

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


  • Superior 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 browser
  • Challenging user governance


Resources for prospective customers include several demo videos and a phone number to contact the sales team.

5. Qualio

This cloud-based eQMS is designed to help simplify comprehensive quality management at life sciences organizations involved in the development, production, and distribution of pharmaceuticals, medical devices, and biotechnology products. The solution includes all of the tools needed for fast-growing organizations to excel at audits, proactively eliminate defects, and achieve the business benefits of quality-driven growth. Qualio is designed specifically under regulatory requirements including FDA, ISO, and GxP.

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, nonconformances, CAPA, audits, suppliers, complaints, and more. Customers can access flexible, transparent pricing models designed to accommodate the needs of organizations from startup to enterprise.

The Best Fit:

Small to mid-market organizations with aggressive growth goals who want an affordable solution for comprehensive quality management and compliance. Qualio is the only eQMS designed specifically for startups, scaleups, and SMBs in the life sciences industry per FDA cGMP, and ISO requirements for pharma, biologics, and medical device manufacturers.


  • “Swift and positive response” from 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



Prospective customers are offered a form to request a demo and product trial opportunities.

Finding the Right QMS Software Fit

Your organization doesn't need to settle for a QMS that's designed for use at manufacturing organizations, a solution that exceeds budget, or an application which requires extensive configuration. Today's top eQMS are flexible, cloud-based solutions that are designed for highly specific business scenarios. There are several great solutions for life sciences organizations, but the best QMS for your company is the one that's right-sized to your needs and growth goals.

When you’ve compiled a list of software options which fit your budget and company’s needs as a customer, verify a prospective vendor’s compliance with FDA, ISO, and GxP requirements. Work to understand how solutions can create efficiency in your current organization and scale to meet your needs.

How does your organization stack up against best-of-class companies in the life sciences vertical for quality best practices, readiness to scale, and risk of adverse findings? Take a short, self-guided assessment to learn what you need to become quality driven.

Get your quality score now. 


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Published by Robert Fenton November 12, 2020