In the early 1990s, the market was overwhelmed by an endless wave of quality systems. Since then, the need to implement them has only grown! 

It is not only a market demand to improve processes, reduce costs, and deliver the best product or service. It is vital to the existence of the company.  

In this post, we will discuss the importance of quality Management systems in the success of a business. Moreover, we have assembled a list of the Top 10 Quality Management Software available in the market. So, you can choose the suitable QMS for your organizational needs and utilize it to transform the quality management game. 

What is a QMS? 

An enterprise-wide Quality Management System (QMS) consists of an established set of policies, procedures, and practices. This system directs and controls critical business activities. In addition to continual improvement in effectiveness and efficiency, the QMS aims to provide optimal performance at all times. 

A quality management system helps businesses to lower costs, improve performance, reduce waste, and provide a training baseline for new and existing employees. 

What Can Quality Management Systems Do? 

QMS improves your business’ operations and enables it to meet customer demands. ISO 9000 defines quality management as documentation of all business processes followed closely by people. This is the basis for many types of quality management systems. In either case, you can ensure compliance with the latest standards and regulations without outsourcing all your processes. An ISO certification enables your company to improve efficiency and reduce waste by implementing Total Quality Management (TQM). All aspects of your business can benefit from TQM, from the front desk to the production line. 

Related Articles: Difference between Quality Management System and Total Quality Management

Nowadays, you can easily find powerful quality management software to assist you with total quality management. Some of the top-rated QMS are: 

1. Qualityze 
2. Qualio 
3. MasterControl 
4. ComplianceQuest 
5. ETQ 
6. Sparta Systems 
7. SmartSolve 
8. Intellect QMS 
9. IQS 
10. isoTracker 

1. Qualityze

Qualityze offers a suite of next-generation Quality Management Software Solutions to help businesses manage end-to-end quality from anywhere. It is built on the most powerful and secure cloud platform, i.e., Salesforce.com. It provides required flexibility, scalability, and security to manage business critical data and processes efficiently. It comes with amazing in-built capabilities to reduce overall process cycle time. The Solution provider also offers data migration and validation services. In addition, the solutions are specifically designed to meet FDA, ISO, and GxP regulations. 

Qualio is a cloud-based quality management solution that comes with robust tools and features to simplify the development, production, and distribution of quality products. It is specifically designed to meet the regulatory requirements with a flexible pricing model. It can accommodate growing needs of the business. Some of the cons with this solution is that it does not supports multi-user ownership for drafting the documents and its complex database schema that makes is challenging for users to import. 

What to Expect: 

1. Added security, powerful administration, and metrics with cloud-based platform. 
2. Integration challenges with third-party systems like ERP and CRM. 
3. Useful for companies working towards ISO certification. 
4. A versatile software with a higher cost. 
5. A little complex interface that may requires users to undergo training for smother user-adoption and limited document size. 

3. MasterControl

MasterControl’s software platform enables companies to improve quality management, such as employee training management, change control and audits, and more. It keeps quality in check from conception to delivery. MasterControl’s extensive portfolio spans the entire product development lifecycle and is a perfect enterprise solution for global organizations. In addition, you may be suitable for implementing and customizing it if you need a complex, highly configurable QMS. 

What to Expect: 

1. Good connectivity among different modules and processes. 
2. An issue with search speed since it supports exact match search. 
3. A challenging user interface with robust features. 
4. Some compatibility issues may arise, depending on the browser you use 
5. Better collaboration and administration. 

4. ComplianceQuest 

ComplianceQuest is a powerful EQMS solution, enabling life sciences and manufacturing firms to streamline product and process innovation, reduce risk, and drive continuous improvement. Our EQMS offers a wide range of solutions, including document, inspection, nonconformance, change management, and many more. Because of this, it is suitable for a wide variety of industries, from highly regulated ones like Life Sciences and Food and Beverage to general and specialized ones such as Automotive, A&D, Oil & Gas, Hi-Tech, and CPG. 

What to Expect: 

1. Advanced reporting capabilities. 
2. Automated and efficient workflows. 
3. Higher costs. 
4. You cannot conduct impact assessment for document or DCR changes. 
5. A delay in deployment because the out of the box setup did not meet FDA and ISO regulatory requirements. 

5. ETQ 

ETQ, a leader in quality, compliance, and health & safety software, is trusted by global brands across industries such as manufacturing and life sciences, food and beverage, and electronics. It features a wide range of features such as document control, supplier quality, audit management, risk management, advanced analytics, and non-compliance/corrective actions to drive business excellence. The software is suitable for quality-focused companies of all sizes and across dozens of industries, including manufacturing, life sciences, food and beverage, electronics, automotive, chemicals, and consumer goods. 

What to Expect: 

1. Great customer service and technical support. 
2. Flexible design for managing workflows. 
3. Some features are complex, and it often crashes. 
4. The interface is not so interactive. 
5. Unclear error messages that may confuse the non-IT users. 

6. Sparta Systems

The TrackWise eQMS product from Sparta Systems is designed for companies with strict GMP requirements. Vendors position their product as a comprehensive QMS solution that allows organizations to become more visible and efficient than ever. Enterprise organizations can use this solution to integrate with a complex ecosystem of systems including ERP, CRM, LIMS, and MES applications. 

What to Expect: 

1. Systematic way to track approval workflows. 
2. Possibility to generate KPIs. 
3. Improved efficiency when it comes to managing tasks. 
4. A little delay in customer service due to limited query manager (Reported by a user on Capterra). 
5. It is expensive and very extensive to train developers and administrators. 

7. SmartSolve

Pilgrim, an IQVIA company, offers SmartSolve, an EQMS software solution that manages compliance, risk, quality, and supply chain processes in the life sciences sector. It provides workflows, documents, and process management and is built under the ISO 9001 standard. Software is rated as pretty good. However, some people have experienced some inherent programming bugs while some reported that their implementation teams often create new bugs when fixing old bugs, in lieu of rushing things. 

What to Expect: 

1. A cumbersome interface with lots of different functionalities 
2. Administrative controls and advanced project management features. 
3. A comprehensive solution for managing risks and quality. 
4. A reliable EQMS to meet compliance requirements. 
5. Some inherent bugs and lengthy implementation cycle. 

8. Intellect QMS

Intellect QMS is designed to improve quality operations and reduce overall quality costs. With our no-code compliance platform, Intellect QMS’s easy-to-use, fast-to-implement, highly flexible, and best-in-class customer support is all available out-of-the-box. You can integrate it with additional business applications. Also, you can meet compliance, enhance audit metrics, improve throughput, reduce the turnaround time, lower quality costs, and reduce returns, defects, and more. Most Intellect’s customers are midmarket companies. It works with startups to Fortune 100 companies. 

What to Expect: 

1. Good in terms of configurability and customer service. 
2. Inconsistencies with the documentation package, execution, and documentation effort. 
3. Some of the FRS, URS, and Guides are not even accurate. (Reported by Capterra user) 
4. Smooth implementation. 
5. Heavy user configuration to configure OOB workflows and configurations to reflect typical QMS workflows for the pharma/med device industry. 

9. IQS 

IQS CAQ helps businesses meet quality requirements. A module is available for each task, as well as standalone usage. For example, a manufacturing company may use these deployments for shipping or receiving goods, planning tests, acquiring data, and planning feasibility. Companies with many suppliers will benefit from advanced quality planning, supplier evaluations, and supply chain quality center modules. High-quality manufacturers will benefit from this module. The several modules of software deal with quality assurance. 

What to Expect: 

1. Higher control of supply chain operations. 
2. Standalone modules for different tasks. 
3. Compatibility issues may arise due to lack of deployment and support options. 
4. Lower inspection costs. 
5. No user reviews on Capterra Yet. 

10. isoTracker

ISO Tracker is a cloud-based Quality Management System designed specifically for small to medium-sized businesses. It has modules for document control, complaints management, auditing, non-conformance management, risk management, and training. In addition, the software includes a capability for Corrective and Preventive action (CAPA). It enables you to demonstrate compliance with ISO 9001, ISO 14001, ISO 45001, ISO 22000, and other quality management standards. A wide range of industries can use it, including healthcare, manufacturing, logistics, engineering, food and beverage, medical products, manufacturing, electronics, chemical, packaging, technology, consulting, and biotechnology. 

What to Expect: 

1. Very good customer support. 
2. Robust user controls for accessibility.
3. Setting it up is quite intensive and confusing because of the category bundles in the solution (as per the Capterra Review). 
4. Lack of root cause investigations in the internal CAPAs. 
5. Incapability to copy folders. 

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