Best enterprise quality management software

Every organization or enterprise is responsible for ensuring quality, compliance, customer experiences, among the industry regulations are fulfilled in their production and service delivery processes. Thus, to ensure compliance with the set industry standards and regulations, organizations adopt various quality management systems and solutions.

With the rapid growth empowered by deep benefits of digital quality management, enterprise quality management system or electronic quality management system (eQMS) is quickly becoming an indispensable solution for modern, quality-conscious enterprises and organizations.

In this post, we have assembled a list of Top 15 best enterprise quality management software available in the market. So, you can choose the suitable and best eQMS Software for your organizational demands and utilize it to transform the quality management process.

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What is enterprise quality management software?

An enterprise quality management software (eQMS), also referred to as eQMS (Electronic Quality Management System), is a category of software that documents and runs processes and responsibilities for achieving quality goals and policies. An eQMS is considered as a modern and digitized method for structuring and running a quality management system (QMS).

An effective and reliable eQMS system helps you to collect, organize, and store data on every relevant information such as accuracies, speed of production, maintenance frequencies, profits/losses, and so on. It also helps you to centralize and automate the key, traditionally manual business processes connected to quality, compliance and product development.

Typical eQMS features include:

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

Cap: What is enterprise quality management software

Top 15 enterprise quality management software in 2022

If you are really aware of the importance of adopting enterprises quality management software (EQMS), dive into our recommendations of the top 15 enterprises quality management software (eQMS) providers on the market in 2022:

#1. MasterControl

This eQMS is a well-known brand in the life sciences industry and also one of the most widely adopted eQMS systems in the vertical. This software is used by 1,000 enterprises in several major regulatory agencies over 30 countries in the world.

MasterControl allows you to manage information documentation, information flows, address compliance and quality management in product development, clinical trials, supplier management, regulatory risk management…

MasterControl is especially suitable for global enterprises with a large portfolio that spans the product development lifecycle. This eQMS is an ideal solution for your organization if you need a complex and highly configurable QMS which can dedicate significant resources toward implementation and customization.

#2 SmartSolve by Pilgrim

SmartSolve is an eQMS software platform by Pilgrim, an IQVIA company that is marketed as the leader in quality and compliance management software and services for the life sciences industry.

This software is built under the ISO 9001 standard for quality management systems and provides document management, workflows, and process management.

SmartSolve can be cloud-based or installed on-premise. Additional capabilities may include features and tools for electronic signatures, analytics, audits, and validation.

This enterprise quality management software is suitable for enterprise organizations that can commit significant budget towards product configuration and don’t need rapid implementation.

#3 TrackWise

TrackWise is an eQMS software platform of Sparta Systems is an industry-leading, cloud-based QMS with integrated modules that work together to support quality, compliance and more efficient and effective decision making in a competitive market.

Innovation built for quality management of TrackWise are based on quality process accelerators, AI enabled quality and world-class technology platform.

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

TrackWise is especially suitable for enterprises who is seeking a robust solution for enterprise quality management.

#4 QPR Metrics

QPR Metrics (previously known as QPR Suite, QPR Software QPR Suite) is a comprehensive system for quality management, environmental management, occupational health and safety as well as for the management of industry-specific regulations and standards.

This eQMS software allows enterprises to integrate multiple initiatives such as ISO9000, ISO14000, OHSAS, BSC, Lean Six Sigma, COSO ERM, etc. into one system focused at supporting employees in their daily activities.

For performance management, QPR Metrics provides an ideal platform for consolidating your portfolio of different management-level performance reporting tools into one scalable, user-friendly and easy-to-maintain business performance solution.

#5 Qualityze

Qualityze is known as a good solution in class quality, compliance and process management system. This eQMS software is built on cloud platform with industry best practices and is easily configurable and scalable. This solution helps organizations to solve quality & compliance issues, develop and maintain good quality policies, procedures and programs to optimize your day-to-day quality operations.

Qualityze 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.

Some pros of this software is: out-of-the-box functionality, intuitive user experience and supports the roll-out of modules based on need. Qualityze is recommended to use for organizations using Salesforce or that have on-site Salesforce experts.

#6 Qualio

This cloud-based eQMS software is designed to help small- to medium-sized life science companies scale and bring their products to market.

Qualio is designed specifically for start-ups, scale-ups and SMBs in life sciences industry, incorporating FDA, cGMP and ISO requirements as standard for pharma, biologic and medical device manufacturers.

Some Pros of this eQMS software comprise: simple, powerful UX and usability, high customer satisfaction, high-touch customer success support, Extra Qualio+ quality and regulatory for businesses with limited quality resource, rapid set-up and validation timeframes and integration with other business tools like Jira and Salesforce.

#7 Arena PLM & QMS

Arena PLM & QMS is designed to help enterprises to design, produce, and deliver innovative products quickly with a unified cloud-based PLM and QMS platform. This eQMS software also helps the companies to ensure regulatory compliance for FDA, ISO, ITAR, EAR, and environmental compliance.

Currently, Arena PLM & QMS supports more than 1,300 complex high-tech electronics and medical device customers around the world to bring electrical, mechanical, and software designs together into a single solution.

With the help of Arena’s proven cloud solutions, your internal teams and external partners can leverage the most comprehensive product development platform to accelerate product launches while reducing expenses, increasing profitability, as well as speeding the time to market.

#8 Greenlight Guru

Greenlight Guru is a reliable quality management platform designed specifically for medical device enterprises. This platform helps enterprises get safer products to market faster, with less risk as well as simplifies FDA and ISO regulatory compliance.

Greenlight Guru also provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits, document control, training, design control and more.

This Medical Device QMS helps implementing best ISO 14985 practices and audit preparations as well. Greenlight Guru is perfect for remote work due to it automatically captures electronic signatures and time stamps, and has already set up to ping users by email when it’s time for them to complete a task.


EASE is estimated as one of the easiest-to-use in Quality Management (QMS) software.

This eQMS software is one of the leading mobile platform manufacturers rely on to administer, conduct and analyze plant floor audits and inspections. From Layered Process Audits (LPAs) to safety, Gemba Walks, 5S… EASE combines simplicity and efficiency with powerful insights to reveal the full picture.

Some pros of EASE comprise: innovative mobile app (iOS and Android) with robust offline support, significant reduction in audit labor time and cost, early risk identification leading to reduced scrap, rework, returns and increased safety…

#10 uniPoint

uniPoint, an ERP-Integrated Quality Management Software system designed by uniPoint is designed to help companies automate their journey toward excellence.

With twenty-five integrated software modules for quality and compliance management, this eQMS software has transformed the quality management systems of 2,000+ Enterprises into a collaborative and paperless environment for continual improvement, while tracking the total administrative cost of quality at every stage.

This solution manages the life-cycle of all key quality events, including: NC’s CA’s, Document Control, Maintenance & Calibration, Auditing, Health & Safety, Education & Training, Surveys, Customer Complaints, Supplier Mgmt, Risk Management, and Validation & the complete Inspection function.

uniPoint is especially suitable for small, mid-size and large enterprise customers with all types of manufactures such as Medical device, Food & Beverage, Life Sciences…


TRACKMEDIUM is a cloud-based QMS system designed to helps enterprises perform internal or supplier audits, track corrective and preventive actions, streamline customer communications, define plans for emergency response as well as ensure compliance with various regulatory standards.

TRACKMEDIUM provides modules including Audit Management, CAPA, Document Control, Management of Change, Nonconformance Management (NCM), and Training Management.

This eQMS enables enterprises to create better and safer products, improve efficiency as well as achieve compliance with industry standards including ISO 9001, 14001 & OSHA while lowering costs and risks. TRACKMEDIUM is ideal for small to medium businesses.

#12 Qualcy eQMS

Qualcy eQMS a friendly, simple and effective solution designed especially for for Bio-Med and Life Science industry requirements. This eQMS software complies with 21 CFR Part11 requirements, 21 CFR820, 21 CFR 210 and 211 requirements and also helps enterprises maintain ISO13485 standard.

Main features of Qualcy eQMS comprise: Document management and design control, Training Record Management, CAPA, NCMR and Supplier Quality and Equipment management.


AIMSCO is considered as the leading cloud-based provider of quality management and production operations applications for manufacturers and industrial companies over the world.  

AIMSCO enables organizations to easily achieve digital transformation and quickly migrate from paper checksheets and spreadsheets. With AIMSCO’s no-code platform, manufacturers may easily build and deploy QMS, MES, Supply Chain and Warehouse Logistics applications.

The AIMSCO eChecksheet platform integrates securely and easily with IoT, equipment, enterprise applications and Office 365. Also, AIMSCO has a powerful self-service analytics, which helps users to drive rapid root cause analysis, alternatives evaluation, process optimization, and machine learning.

#14 IQS

With 30+ years of experience, IQS is proving as a modern, enterprise-grade market-leading quality and compliance management software system. The addition of Software as a Service (SaaS) web delivery model has helped IQS provide the availability and security demanded by today’s enterprises and stay on the leading edge of what manufacturers need to compete in the global market.

Integrated modules in IQS comprise: Audit management, Change management/ECN, Customer complaint tracking, Document management, Equipment maintenance, Employee training, Gauge calibration, FMEA/control pans, Inspections/SPC, Supplier performance…

#15 GlobalSuite

This solution is a pioneering GRC solution that automates risk management, ensures regulatory compliance and streamlines processes. GlobalSuite also includes other specialized services – professional advice on the regulations of each sector, support with software, training, external DPO and other management systems.

GlobalSuite makes it easy for you to comply with industry frameworks and ensure you work with best practices from a broad repository of international standards controls and specific regulations.

This software provides you with a risk analysis adaptable to any methodology with the possibility of carrying out an assessment of them with risk maps and automatic dashboards. It also allows you to make an automatic adequacy plan with workflows that offer you a comparison between periods, in addition to the history of compliance.


At current, effective and reliable enterprise quality management (eQMS) systems are flexible, cloud-based platforms and designed for highly specific business scenarios. Thus, there are many valuable choices for your enterprise which meet your demands on extensive configuration, without exceeding your budget.  

Hopefully, Top 15 best enterprise quality management systems we recommended above will most closely align with your needs and growth goals.

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