8.9
Editor’s Rating:
Best Overall
EtQ Reliance: Charts
EtQ Reliance
  • Provides in-depth audit trails
  • High configurability and customization options
  • Provides in-depth audit trails
8.8
Editor’s Rating:
Best Lifecycle Quality Management
MasterControl Qx: Version Management
MasterControl Qx
  • Automated notification system
  • Completes validation quickly
  • Responsive customer support
8.8
Editor’s Rating:
Best for Collaboration
Unifize: Data Dashboard
Unifize
  • Built for mid-size to enterprise-level companies
  • Drag and drop interface
  • Integrations with existing ERP

Using our advanced review methodology, our team has carefully evaluated the best QMS software to find the top options for manufacturers across various industries. We ranked our picks based on value for money, customization options, data analysis and reporting, and compliance with standards like ISO or FDA.

1 ETQ Reliance - Best Overall

Why We Chose It: ETQ Reliance is a quality management system that enhances critical business processes and elevates overall quality standards. We found that its user-friendly and adaptable nature sets this software apart, making it a good fit for businesses with diverse and unique requirements. The web-based platform allows rapid implementation and regular updates to align with evolving quality management needs.

Industries: Healthcare, electronics and appliances, food and beverage, manufacturing, life sciences

Best Overall:
EtQ Reliance

EtQ Reliance: Charts
EtQ Reliance: Applications
EtQ Reliance: Document Control
What We Like
Provides in-depth audit trails
High configurability and customization options
What We Don’t Like
Might be a challenge for less tech-savvy users
Requires consult call for pricing
Overview
Client OS: Web
Deployment: Cloud Hosted

2 MasterControl Qx - Best Lifecycle Quality Management

Why We Chose It: MasterControl Qx is a QMS focusing on quality from conception through manufacturing to delivery. This empowers businesses to maintain quality throughout the product life cycle. And we found that features like electronic document access and automatic notification systems improve efficiency.

Finally, the secure cloud-based nature of MasterControl ensures accessibility to the latest updates and features, making it a practical and future-proof choice. The responsive support also makes it a top choice for those manufacturers in regulated industries.

Industries: Pharmaceuticals, medical devices, biotechnology

Best Lifecycle Quality Management:
MasterControl Qx

MasterControl Qx: Version Management
MasterControl Qx: Tasks
MasterControl Qx: CAPA
What We Like
Completes validation quickly
Extremely responsive support
Includes automated notification system
What We Don’t Like
High learning curve
Requires consult call for pricing
User interface can be slow at times
Overview
Client OS: Web
Deployment: Cloud Hosted

3 Unifize - Best for Collaboration

Why We Chose It: Unifize is an eQMS software built for easy collaboration from the shop floor to all departments of a manufacturing business. Integrations with email and existing ERP and PLM systems make Unifize an excellent add-on software for quality management. Enterprise-grade security and management of roles will help meet compliance needs.

Industries: Automotive, medical devices, manufacturing, food production, aerospace, cosmetics

Best for Collaboration:
Unifize

Unifize: Data Dashboard
Unifize: Track Conversations
Unifize: Internal Messages
Unifize: Traceability Details
What We Like
User-friendly interface
Customizable with drop and drag features
Effective customer support and easy implementation
What We Don’t Like
Limited sorting functions
Reporting to PDF can be cumbersome
Overview
Price Range: $$
Starting Price: $50/user/month
Client OS: Windows, macOS, iOS, Android, Web
Deployment: Cloud Hosted

4 Greenlight Guru - Best for Medical Device Industry

Why We Chose It: We picked Greenlight Guru because it’s specifically designed for the medical device industry. It facilitates quicker market entry of safer products while simplifying FDA and ISO compliance. The platform uniquely combines document control with design traceability, providing tools for managing standard operating procedures, policies, and work instructions. Finally, Greenlight Guru ensures that suppliers adhere to essential quality standards, enhancing overall product reliability.


Greenlight Guru: Risk Management
Greenlight Guru: Document Management
Greenlight Guru: Quality Events
Greenlight Guru: Design Control
What We Like
Responsive customer support
Intuitive, user-friendly interface
Automated document routing and revision control
What We Don’t Like
Tedious mass document input
Detailed, specialized modules can pose a learning curve
Overview
Price Range: $$$
Starting Price: $600/user/month
Client OS: Web
Deployment: Cloud Hosted

5 Qualio - Best for Life Sciences Sector

Why We Chose It: Qualio is an eQMS tailor-made for life-science industries, making it an ideal solution for medical device companies, biotech/therapeutic firms, and pharmaceutical contractors. One top feature we found is its ability to simplify complex processes and help businesses meet industry standards such as ISO 14971 and ICH Q9.

A Qualio subscription includes all software in the package for up to 10 users, with the option to add additional users for a nominal annual fee. While there is no free trial, the pricing can accommodate various business sizes.

Best for Life Sciences Sector:
Qualio

Qualio: Create a New Corrective Action Preventive Action
Qualio: Open Corrective Action Preventive Action
What We Like
Good size program for the price
Meets FDA standards
Good fit for first-time QMS
What We Don’t Like
Potentially complex setup
Limited non-life science use
Requires regular updates for best performance
Overview
Price Range: $$$
Starting Price: $12,000
Client OS: Web
Deployment: Cloud Hosted

6 TrackWise - Strong Reporting Capabilities

Why We Chose It: TrackWise delivers strong reporting capabilities for industries that demand rigorous quality and compliance monitoring. Its strength lies in providing granular tracking of quality incidents, deviations, and CAPAs, enabling businesses to capture and analyze detailed data at every stage.

TrackWise’s sophisticated reporting tools allow for in-depth analysis and insights. These include compliance, audit, supplier quality, and training and competency reports. TrackWise is a decent choice for organizations prioritizing detail-oriented quality management practices.

Industries: Pharmaceuticals, information technology and services, biotechnology, medical devices

Strong Reporting Capabilities:
Qualio

Qualio: Create a New Corrective Action Preventive Action
Qualio: Open Corrective Action Preventive Action
What We Like
Good size program for the price
Meets FDA standards
Good fit for first-time QMS
What We Don’t Like
Potentially complex setup
Limited non-life science use
Requires regular updates for best performance
Overview
Price Range: $$$
Starting Price: $12,000
Client OS: Web
Deployment: Cloud Hosted

7 uniPoint - Best for Growing Companies

Why We Chose It: uniPoint made our list because it’s highly scalable. It’s suited for startups with as few as ten users and designed to efficiently support businesses with 50 to 100 employees. uniPoint offers concurrent user access rather than named seats, enabling businesses to expand their user base without limitations.

Its flexible, modular structure means companies pay only for the features they need. The software’s comprehensive core modules address various quality management aspects, including non-conformance and corrective actions, making it a versatile tool for growth-oriented companies.

Industries: Aerospace, automotive, manufacturing, job shops, life sciences, oil and gas, food and beverage

Best for Growing Companies:
uniPoint

uniPoint: Key Indicators Dashboard
uniPoint: Inspection Bubble Drawing
uniPoint: Inspection Mobile
uniPoint: Cost of Quality Trend Analysis
uniPoint: Health and Safety
uniPoint: Key Indicators
uniPoint: Inspection Records
uniPoint: Equipment Maintenance Schedule
uniPoint: Document Control
What We Like
Configurable, modular design with a variety of add-on modules
Mobile-first design on uniPoint Web version
Allows concurrent users rather than named seats
What We Don’t Like
No set pricing due to configurable design
Certain industries may require add-ons to meet compliance or certification
Not a fit for businesses looking for a LMS system
Overview
Price Range: $$$
Starting Price: $225/user/month
Client OS: Windows, Web
Deployment: Cloud or On-Premises

8 DELMIAworks - Best End-to-End Solution

Why We Chose It: DELMIAworks is an advanced Enterprise Resource Planning (ERP) system designed to amplify quality management operations. It bolsters defect prevention and continuous improvement efforts, integrating effortlessly with methodologies like Six Sigma DMAIC. This synergy allows for a precise, scalable quality management system that ensures reliability and consistency.

The system is instrumental in the execution, planning, and evaluation of all customer interactions, from the initial order through to product delivery. Moreover, DELMIAWorks is pivotal in helping companies maintain compliance with a wide range of quality and regulatory standards, including ISO 9001, ISO 13485, and FDA medical device registration. And it supports advanced manufacturing capabilities, such as low-particulate production, statistical process control, and cutting-edge vision inspection.

Industries: Aerospace, automotive, food and beverage, plastics, rubber, general manufacturing

Best End-to-End Solution:
DELMIAWorks

DELMIAWorks: Overall Equipment Efficiency Dashboard
DELMIAWorks: Real-time Plant Floor Dashboard
DELMIAWorks: VIN Generator
DELMIAWorks: Manufacturing Scheduling and Production Planning
DELMIAWorks: Customizable BI Dashboard
DELMIAWorks: Open Order Report
What We Like
Streamlines manufacturing operations
Real-time visibility into the manufacturing process
Integration with other systems for improved efficiency and productivity
What We Don’t Like
Not all modules are accessible via mobile app
Pricing details are unavailable from the developer
No web interface
Overview
Client OS: Windows
Deployment: Cloud or On-Premises

9 Intellect QMS - Most Adaptable Pick

Why We Chose It: Intellect QMS made our list due to its adaptability. Businesses across various sectors will appreciate its out-of-the-box solutions that align with industry best practices and are fully customizable. This ensures that the software can be tailored to fit seamlessly into any existing workflow.

A highlight of Intellect is its no-code compliance platform. This feature allows users without a technical background to modify or create apps, workflows, and reports. All this is a testament to Intellect’s commitment to user-friendly design and functionality. However, default workflows might not always align with specific industry standards, necessitating user configuration. Additionally, while the software’s customization is a strength, it can sometimes require a deeper understanding than some users might expect.

Industries: Chemical manufacturing, electronics, medical devices, automotive, energy

Most Adaptable Pick:
Intellect QMS

Intellect QMS: Dashboard
Intellect QMS: Audit Management
Intellect QMS: Console
Intellect QMS: CAPA
Intellect QMS: Change Management
Intellect QMS: Complaint Management
Intellect QMS: Deviation Management
Intellect QMS: Document Control
Intellect QMS: Employee Training
Intellect QMS: Feedback Management
Intellect QMS: Nonconformance
Intellect QMS: Risk Management
Intellect QMS: Supplier Management
Intellect QMS: Validations
What We Like
Easy to implement
On-premise and Cloud
Support for ISO standards and FDA regulations
What We Don’t Like
Requires a quote for pricing details
Initial training can be complex
Overview
Deployment: Cloud or On-Premises

10 Ideagen - Best for Food and Beverage

Why We Chose It: Ideagen is a top choice for its specialized food and beverage edition, offering supply chain visibility and traceability. The software transforms food management systems by digitizing the tracking of raw materials and products. It also enhances data collection to pinpoint potential risks and weaknesses.

With features geared towards CAPA, quality control, and management reporting, it streamlines operations and prevents costly recalls. Additionally, Ideagen covers compliance management, document control, and audit management to ensure a comprehensive approach to food safety and quality.

Best for Food and Beverage:
Ideagen Quality Management

Ideagen Quality Management: Document History
Ideagen Quality Management: Workflow
Ideagen Quality Management: Document Lists
Ideagen Quality Management: Test Instance
Ideagen Quality Management: Report Designer
Ideagen Quality Management: Dashboard
Ideagen Quality Management: Document Tree
Ideagen Quality Management: Custom Workflow Reports
Ideagen Quality Management: Groups Administration
What We Like
Provides a centralized repository for information
Gap analysis streamlines audit preparation
What We Don’t Like
Price information not provided by the developer
Some customization limitations
Overview
Client OS: Web
Deployment: Cloud Hosted

11 QT9 QMS - Best for SMBs

Why We Chose It: We picked QT9 QMS because it suits small and medium-sized businesses. This is due to its scalability and affordability. It offers a comprehensive suite of QMS features without the complexity or high costs typically associated with such systems. QT9 QMS simplifies compliance, audit management, and document control, making it accessible for smaller teams without extensive IT support.

The software’s modular design allows SMBs to choose and scale features according to their specific needs, avoiding unnecessary functionalities that larger enterprises might require. This tailored approach, combined with its intuitive design, makes QT9 QMS an excellent fit for SMBs seeking to enhance their quality management processes without overextending their resources.

Industries: Life sciences, manufacturing, pharmaceuticals, medical devices, food and beverage, plastics, aerospace

Best for SMBs:
QT9 QMS

QT9 QMS: To Do List
QT9 QMS: Corrective Actions
QT9 QMS: Document Control
QT9 QMS: Risk Categories
QT9 QMS: Portals
QT9 QMS: Document Control
What We Like
Has 23+ pre-installed modules for advanced functionality.
Flexible deployment options with access on all devices.
Syncs with QuickBooks.
What We Don’t Like
Pre-included modules may be overwhelming for smaller businesses.
Slightly dated user interface.
Implementation and training are required plus an additional fee.
Overview
Price Range: $$
Starting Price: $2,200/user/year
Client OS: Windows, macOS, Linux, iOS, Android, Web
Deployment: Cloud or On-Premises

12 Qualcy - Transparent Pricing Model

Why We Chose It: We went with Qualcy because it has a transparent pricing model. Typically, pricing begins at approximately $799 per month. The minimum requirement for each plan is five users for a $495 subtotal, plus the $299 monthly fee for backup and maintenance support.

The basic plan from Qualcy includes 500 GB of storage, comprehensive reporting features, phone support, online training, and access to six key modules. This makes it a solid choice for small to mid-sized biomedical firms aiming to enhance their security measures and uphold ISO 13485 standards.

Industries: Medical devices, pharmaceutical, biomedical

Transparent Pricing Model:
Qualcy eQMS

Qualcy eQMS: Document Management
Qualcy eQMS: CAPA
Qualcy eQMS: Training
Qualcy eQMS: Process Overview
What We Like
Transparent pricing and free trial
Role-based access control
Scalable, modular architecture
What We Don’t Like
Not a great fit for oil and gas
Limited in-app support
Lengthy setup process
Overview
Price Range: $$$
Starting Price: $799/month
Client OS: Web
Deployment: Cloud or On-Premises

13 Intelex - Best for EHSQ Management

Why We Chose It: Intelex made our list because of its comprehensive EHSQ (Environment, Health & Safety, and Quality) management capabilities. Its suite of applications covers document control, audits and inspections, and sustainability performance tracking. Intelex can also handle risk, compliance, and incident management.

Additionally, the platform supports organizations in managing their environmental impact by tracking emissions, waste management, water usage, and other sustainability indicators. Intelex’s data analysis and reporting capabilities help organizations track KPIs, identify trends, and make data-driven decisions to to improve their EHSQ outcomes.

Industries: Aerospace, automotive, consumer goods, construction, food and beverage, healthcare, manufacturing, pharmaceuticals, oil and gas

Best for EHSQ Management:
Ideagen Quality Management

Ideagen Quality Management: Document History
Ideagen Quality Management: Workflow
Ideagen Quality Management: Document Lists
Ideagen Quality Management: Test Instance
Ideagen Quality Management: Report Designer
Ideagen Quality Management: Dashboard
Ideagen Quality Management: Document Tree
Ideagen Quality Management: Custom Workflow Reports
Ideagen Quality Management: Groups Administration
What We Like
Provides a centralized repository for information
Gap analysis streamlines audit preparation
What We Don’t Like
Price information not provided by the developer
Some customization limitations
Overview
Client OS: Web
Deployment: Cloud Hosted

What is Quality Management System (QMS) Software?

Quality Management System (QMS) software is a digital tool that helps improve quality processes, ensuring compliance with regulatory ISO standards and FDA requirements.

The main functions of QMS software include: Analyzing business risks Setting quality objectives on product development Implementing workflows to achieve standards Auditing the product lifecycle

This integrated approach allows companies to craft standard operating procedures (SOPs) to optimize their business processes.

Read more: What is a Quality Management System (QMS)? - ISO 9001 Processes

What is EQMS?

EQMS, or Enterprise Quality Management Software, is a digital system that helps improve quality processes, compliance, and performance across all operations. Though the terms EQMS and QMS are used interchangeably, EQMS is specifically tailored to:

  • Integrate quality management into all facets of enterprise operations.
  • Offer a broader, more holistic approach to quality across various functions, like manufacturing, supply chain management, and regulatory compliance.
  • Leverage AI, machine learning, and IoT to enhance quality processes organization-wide.

Read more: What is EQMS?

uniPoint Key Indicators Dashboard
Key indicators on the uniPoint dashboard.

QMS Key Features

Quality management systems offer a wide variety of functionality. Modules often include the following core functions:

  • Quality Control: Set objectives on quality processes related to cycle times, scrap/waste percentages, defect rates, measurement deviations, durability metrics, and more.
  • Risk Management and Analysis: Create what-if scenarios to reliably analyze potential costs related to quality exceptions. Predict failure and service rates, as well as their financial implications.
  • Workflow Management: Define all processes involved in manufacturing an end-product. Includes reminders, timers, and alerts. Determine corrective action assignments.
  • Corrective Action/Preventative Action (CAPA): Includes task assignments, reporting, and monitoring to ensure the right response is implemented when quality has deviated outside pre-identified standards.
  • Parts Non-conformance: Define the dimension parts are measured upon for non-conformance. Track a database of standardized parts metrics. May include more sophisticated monitoring controls that integrate with operational equipment.
  • Customer Complaint Management: Assist service personnel in quickly resolving customer issues.
  • Audits and Inspections: Define, schedule, and execute regular audits and inspections to ensure continuous improvement of business processes.
  • Document Management: Coordinate the data management challenge, facilitate collaboration, and ensure easy access to important quality management documentation.
  • Training Management: Ensure employees are trained and certified in key areas to meet compliance standards.
  • Reporting and Business Intelligence: Reference key performance indicators and performance dashboards to turn quality management data into actionable business intelligence.
Corrective Action Charts TRACKMEDIUM QMS Software
A corrective actions chart in TRACKMEDIUM.

Industry-Specific Types of QMS Software

Industry-Agnostic QMS Software

Designed to be applicable across industries rather than tailored to a single sector’s specific needs. This software provides a framework for managing quality processes, compliance, and performance within an organization, regardless of its field of operation.

Medical QMS Software

Ensures that medical devices are designed and manufactured in compliance with regulations set by the U.S. Food and Drug Administration (FDA), the European Union’s Medical Device Regulation (MDR), and other international standards like ISO 13485.

Food and Beverage QMS Software

Ensures the safety and quality of food products from production to distribution. It facilitates compliance with HACCP (Hazard Analysis and Critical Control Points), FDA regulations (including FSMA - Food Safety Modernization Act), and GFSI (Global Food Safety Initiative) benchmarks.

Pharmaceutical QMS Software

Helps manage the quality of pharmaceutical products, including prescription drugs, over-the-counter medications, generics, vaccines, and biopharmaceuticals. It adheres to pharmaceutical regulations like FDA 21 CFR Part 210/211, Part 11 (for electronic records), and Good Manufacturing Practices (GMP).

Automotive QMS Software

Helps design, develop, test, and manufacture vehicles and their components. It enhances engine management, safety systems, infotainment, and autonomous driving technologies. Automotive QMS aligns with automotive quality standards like IATF 16949.

Aerospace QMS Software

Utilized in designing, simulating, testing, and maintaining aircraft and spacecraft, including commercial airplanes, military jets, drones, and satellites. It aids in managing complex systems and components, ensuring they meet rigorous safety and performance standards. Aerospace QMS ensures compliance with aerospace standards like AS9100.

Quality Management Software Benefits

QMS Benefit #1: Ensure Regulatory Compliance

Managing the product lifecycle for regulatory compliance is complex work. Manufacturers are often subject to an alphabet soup of regulatory standards (FDA, ISO 9001, Title 21 CFR Part 11, NERC, SSOP, HAACP, and more). Compliance can be required for permitting, an eligibility condition for bid consideration, or a business necessity to avoid penalties or other legal action. A quality system provides the monitoring and reporting tools to simplify the complexity.

Different types of manufacturers need to comply with different regulations. For instance, manufacturers of medical devices, food, cosmetics, and chemicals all have unique, strict regulations to abide by. Selecting an industry-specific QMS system can help control compliance for specific industries.

Waypoint Global Suite Reports QMS Systems
Create quality management reports in Waypoint Global Suite.

QMS Benefit #2: Analyze and Reduce Risk

Every business faces risk: production errors, product defects, unexpected service work, and more pose a threat to the financial health of companies. Improved quality management offers a chance to mitigate these business risks and smooth out the variance in financial projections. QMS, with quality standards and audit management tools, provides an effective way to identify the root cause of any issues, allowing manufacturers to provide corrective action and enjoy higher-quality results.

Analysis tools can quantify the financial risks related to quality exceptions. Identifying the cost of quality management improvements versus the likely impact of reduced financial liability is one of the more challenging business issues facing manufacturers.

QT9 QMS Document Control QMS Solutions
Manage documents in QT9 QMS.

QMS Benefit #3: Increase Customer Satisfaction

Customer satisfaction is key to the success of every business model. Customers continually evaluate products for quality, reliability, and whether or not they do what they should do. Quality assurance modules provide ways to review products for defects before they get sent to retailers or consumers, allowing manufacturers to make corrections. Fewer defective products on the market mean happier customers.

CAPA Reporting The Lean Machine Quality Management Software
CAPA Reporting in The Lean Machine.

Common Certifications, Standards, and Compliance with QMS

ISO standards include:

ISO Standard Meaning
ISO 9001 Sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity
ISO 13485 Similar to ISO 9001 but for medical devices. Has a specific requirement for software validation and requires validation reports to verify for the auditor that it will work as intended. Includes requirement for CFR 21 specific electronic signatures
ISO 50001 Energy management standard for addressing the energy consumption and use of an organization
ISO 27001 Information security, similar to ISO 9001 but with a change in focus to data security and integrity vs product quality
ISO 45001 Health and safety, similar to ISO 9001 but with a change in focus to employee safety vs product quality
ISO 14001 Health and safety, similar to ISO 9001 but with a change in focus to environment concerns vs product quality
ISO 17025 Laboratory testing and calibration

FDA certifications include:

FDA Meaning
FDA 21 CFR Part 11 Electronic records and electronic signatures
FDA 21 CFR Part 211 Drug and pharmaceutical manufacturing
FDA 21 CFR Part 820 Medical device manufacturing and distribution

Other common QMS standards include:

  • API Q1/Q2: Standards specific to the oil and gas industry that are similar in nature to ISO 9001. API W2 has the explicit requirement for contingency planning. Both API Q1/Q2 make the distinction between corrective and preventive action (something ISO 9001 does not)
  • ASME: Highly focused on product specifications and work instructions. Little emphasis on standard QMS requirements such as nonconformities and corrective action
  • API Design Stamps: Similar to ASME. Components have specific technical requirements to be met. Generally coupled with API Q1/Q2
  • IATF 16949: Automotive quality management standard similar to ISO 9001 with additional requirements
  • AS 9100: Aerospace quality management standard similar to ISO 9001 with additional requirements
  • HACCP: Food safety preventative maintenance
  • SQF: Food quality management

Non ISO Standards

  • Statistical Process Control (SPC): Identify product quality issues and process variations in order to take corrective action before extensive issues occur, as well as improve process performance. May pair well with a QMS but is better used to report on the output of the production process.
  • Production Design Lifecycle System (PDLC): Mainly used for showing verification and validation of a product design requirements. Focus on the interaction between suppliers, engineering, and test data. Includes production part approval processes (PPaP).
Intellect QMS Software Dashboard
The dashboard of Intellect QMS showing activities.

How Much Does QMS Software Cost?

QMS software ranges from $5,000 to $150,000 a year. Pricing of quality management systems depends on several factors:

  • Number of users
  • Required functionality
  • Additional integrations

Another variable to consider is whether to choose an on-premise or cloud-based system. Generally, an on-premise software will have a one-time perpetual licensing fee while a cloud platform will be part of a monthly or annual subscription. The one-time fee and setup often results in a higher cost of entry while SaaS QMS can be more expensive over time.

Integrating QMS and ERP

Quality management software incorporates information from across the enterprise. QMS systems are often found within larger ERP software.

Because QMS systems typically operate best when they are taking a holistic approach to the enterprise challenge of optimizing quality, companies may need to manage integrations with other information systems, such as:

  • Supply chain management systems manage the provisioning of goods from suppliers through to the customer. Relaying information regarding quality issues stemming from certain suppliers is an important piece of the quality management puzzle.
  • Customer relationship management software programs provide a coordinated approach to capturing customer-specific information. Order histories and other customer interactions are logged to CRM programs. The ability to flow quality issue information from CRM software to QMS programs is important. It can assist in ensuring that quality issues addressed post-sale are being addressed both in terms of service work and process improvement.
  • Material resource planning and production scheduling software manages the materials required for production and the processes that go into the manufacturing operations. Importing quality-related information from the QMS to the MRP system will help create more accurate manufacturing plans and forecasts.
TrackWise Events QMS Software
Create tasks and events for employees in TrackWise.

Further Reading

All Products

No products found
uniPoint Screenshot

uniPoint

★★★★★
★★★★★
(3)
uniPoint is a configure-to-order QMS solution designed to help your company automate its journey toward excellence.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$225/user/month
Client OS
Windows, Web
Deployment
Cloud or On-Premises
EtQ Reliance Screenshot

EtQ Reliance

★★★★★
★★★★★
(1)
EtQ Reliance is a quality management system (QMS) known for its adaptability and ease of use, catering to various business needs. It’s particularly recognized for its ability to automate processes, enhance decision-making through analytics and AI, and maintain regulatory compliance, thus contributing to overall business excellence. The software stands out for its robustness in managing document control, non-conformance handling, corrective action, and various other quality processes​.
Client OS
Web
Deployment
Cloud Hosted
MasterControl Qx Screenshot

MasterControl Qx

★★★★★
★★★★★
(1)
MasterControl is a QMS software system designed to streamline quality processes and ensure regulatory compliance across various industries. Its standout features include document control, training management, and the integration of quality event management, which collectively contribute to enhancing organizational compliance and efficiency. It is a top-rated QMS system in the Life Sciences space.
Client OS
Web
Deployment
Cloud Hosted
Unifize Screenshot

Unifize

★★★★★
★★★★★
(4)
Unifize is a quality management software designed to enhance organizational collaboration and communication. It stands out for its highly customizable and adaptable platform, which allows companies to tailor the system to fit their specific processes, fostering real-time process improvements and operational efficiencies. The software is known for its intuitive interface and user-friendly design, making integrating and optimizing various processes easy.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$50/user/month
Client OS
Windows, macOS, iOS, Android, Web
Deployment
Cloud Hosted
Greenlight Guru Screenshot
Greenlight Guru is a cloud-based quality management software tailored for the medical device industry. It excels in managing both premarket and post-market phases, offering features like risk management, design control, and audit management. It maintains traceability in design control and automates document routing and revision control.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$600/user/month
Client OS
Web
Deployment
Cloud Hosted
Qualio Screenshot

Qualio

★★★★★
★★★★★
(11)
Qualio, a cloud-based eQMS, helps companies in the life sciences sector replace traditional paper-based quality management processes with digital solutions. The platform hosts a wide range of tools for effective supplier management and risk mitigation. It supports robust product development processes from a single source of truth to ensure compliance and audit readiness. Additionally, Qualio provides pre-configured templates for FDA and ISO compliance, and access to quality experts, making it a valuable tool for organizations aiming to meet and exceed quality assurance goals.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$12,000
Client OS
Web
Deployment
Cloud Hosted
QT9 QMS Screenshot

QT9 QMS

★★★★★
★★★★★
(1)
QT9 QMS is a cloud-based quality management system that helps business teams integrate data from multiple systems into one flexible and intuitive platform.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$2,200/user/year
Client OS
Windows, macOS, Linux, iOS, Android, Web
Deployment
Cloud or On-Premises
DELMIAWorks Screenshot

DELMIAWorks

★★★★★
★★★★★
(1)
DELMIAWorks, [formerly IQMS EnterpriseIQ](https://blogs.solidworks.com/delmiaworks/what-is-iqms/) before being acquired by Dassault Systèmes, is an end-to-end manufacturing ERP. Top features include real-time shop floor control, materials management, and quality compliance. Catering to the needs of small to mid-market companies in industries such as aerospace, automotive, and plastics, DELMIAWorks offers real-time insights into manufacturing operations. The software supports various languages like English, Czech, Dutch, French, German, Irish, Italian, Spanish, and Chinese (simplified and traditional). Mobile apps are available for several modules to provide remote access.
Client OS
Windows
Deployment
Cloud or On-Premises
Qualcy eQMS Screenshot

Qualcy eQMS

★★★★★
★★★★★
(2)
Qualcy is a web-based QMS software supports document, training, supplier quality, and equipment management. It also offers non-conformance, CAPA, and auditing features. Qualcy meets 21 CFR 820, 210, 211 and ISO 13485 standards.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$799/month
Client OS
Web
Deployment
Cloud or On-Premises
Intellect QMS Screenshot
Intellect QMS is a quality management software that helps leaders meet FDA, ISO, and other global GxP regulatory compliance requirements. It provides onsite and remote workforce with virtual auditing, online approvals, 21 CFR Part 11 electronic signatures. It ensures teams can access only approved and up-to-date quality documents, data, reports and analytics anytime, on any device. The no-code platform allows users to create and configure applications without needing specialized programming skills.
Deployment
Cloud or On-Premises
Ideagen Quality Management Screenshot

Ideagen Quality Management

★★★★★
★★★★★
(10)
Ideagen Quality Management Software, formerly known as Qualtrax, is a modular SaaS solution designed to integrate seamlessly with existing organizational processes. It focuses on digitalizing quality management processes and achieving compliance with industry standards. The software features document management, workflow automations, and helps teams in identifying and rectifying issues proactively.
Client OS
Web
Deployment
Cloud Hosted
TRACKMEDIUM Screenshot

TRACKMEDIUM

★★★★★
★★★★★
(2)
Trackmedium QMS is a quality management system software. It provides advanced modules for audit management, CAPA, document control, and training management. Its user-friendly drag-and-drop designers allow for easy customization of applications to meet specific company requirements. By facilitating better product safety, efficiency improvements, and compliance with industry standards like ISO 9001, ISO 14001, and OSHA, Trackmedium QMS helps businesses mitigate risks.
Price Range
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   $     $     $     $     $   
Starting Price
$299/month
Client OS
iOS, Android, Web
Deployment
Cloud Hosted
Waypoint Global Suite Screenshot
Waypoint Global Suite is a quality and document management system. Designed by Waypoint Global, this solution was formerly known as Powerway.
Client OS
Windows
Deployment
On-Premises
AssurX Screenshot

AssurX

★★★★★
★★★★★
(3)
AssurX is a quality management software featuring audit management, corrective action, preventive action (CAPA), and compliance handling. The platform also includes change control and risk management. Additionally, AssurX supports training, customer quality, and supplier quality management. This low-code platform enables easy customization, allowing businesses to adapt the software to their specific needs.
Client OS
Web
Deployment
Cloud or On-Premises
HQMS Screenshot

HQMS

★★★★★
★★★★★
(3)
Harrington Quality Management Software (HQMS) is the flagship world-class software of Harrington Group International. The quality management system provides tools for process improvement, compliance and online quality management. It includes modules for document control, audits, corrective action, calibration, training, and risk management. HQMS’s customization capabilities are significant, allowing businesses to tailor it to their unique requirements. It addresses the needs of manufacturing, aerospace, medical device, pharmaceutical, healthcare, government and other service industries. EQMS was designed to manage five key drivers of shareholder value: customers, employees, supply chain, products, and services. It is an “all-in-one” solution.
Client OS
Windows, Web
Deployment
Cloud or On-Premises
Effivity Pro Screenshot

Effivity Pro

★★★★★
★★★★★
(2)
Effivity is a quality management software for monitoring a business’s health, safety, and environmental standards. The software’s ability to digitize and streamline QHSE functions makes it a good fit for companies seeking to enhance their compliance processes. Key features include a training module, document control, and design and development management. Users can tweak design input and output, controls, and changes to enhance efficiency in the development process.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Client OS
Android, Web
Deployment
Cloud or On-Premises
Qualityze EQMS Screenshot

Qualityze EQMS

★★★★★
★★★★★
(1)
Qualityze is a cloud-based Enterprise Quality Management System (EQMS) built on the Salesforce platform. It is designed to help organizations of various sizes ensure product safety, improve quality, and comply with regulatory standards. Its key features include complaint management, document management, workflow process management, and more, all aimed at enhancing quality processes across the organization. Qualityze EQMS offers compliance with ISO 9001, ISO 13485, 21 CFR Part 11, IATF 16949, 21 CFR 820, and AS 9100.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Client OS
Web
Deployment
Cloud Hosted
Quality Essentials Suite Screenshot

Quality Essentials Suite

The Quality Essentials Suite from Horizons International is designed to support manufacturers in collecting and measuring their quality performance data throughout their manufacturing operations so that it is accessible for analysis and reporting in a timely manner. Reduce compliance costs by quickly recording test values for environmental requirements (temperature, moisture content, etc.) or for products (height, weight, silicon %, etc.) during your manufacturing process.; Efficiently manage QA
Client OS
Windows
QMSC Screenshot

QMSC

QMSC is a SaaS based supplier management solution for corporations who find that Excel and access databases and spreadsheets are no longer tenable to managing their portfolio of suppliers. Supplier performance is at the core of the QMSC solution. Customers rely on this platform because they have hundreds, and often thousands of suppliers, typically located around the globe, and they need a way to ensure quality is maintained across their entire supply chain. The customers goal is to improve
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Client OS
Web
Deployment
Cloud Hosted
Total Lean Management Screenshot

Total Lean Management

★★★★★
★★★★★
(7)
Total Lean Management (TLM) software is the first QMS software to recognize both user groups found in every quality system—Upstream and Downstream. Upstream users include the quality professionals in your organization who are familiar with the full scope of MMS activities—responsible for the set up, administration, and the creation of workflows.; and Downstream users are anyone else who needs access to participate, approve, read procedures, sign off on training records, complete quizzes, enter
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$80/user/month
Client OS
Windows, Web
Deployment
Cloud or On-Premises

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