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QT9 Software Blog

Discover the Benefits of eQMS Software

Discover the benefits of eQMS software
Discover the Benefits of eQMS Software
7:27

If you’ve ever had to answer an auditor’s request for documentation that just cannot be found, then you know the frustration of a broken audit trail.

Modern eQMS software centralizes, connects and automates quality management processes, delivering real-time traceability and reducing compliance risks. Here we explore eQMS software and how it can impact your quality management operations and your business.

Contents

What is eQMS software?

How does eQMS software work?

How can eQMS software help you?

How does eQMS software help meet regulatory standards?

How much does eQMS software cost?

What is the best eQMS software for you?

What is eQMS software?

eQMS software is an electronic quality management system that helps organizations manage and maintain their quality management processes related to product development, documentation and regulatory compliance. The term "eQMS" stands for electronic Quality Management System software, often referred to simply as QMS software.

Unlike a quality management system that consists of paper-based binders, spreadsheets and file cabinets, eQMS software provides a single digital platform – a centralized “source of truth” – to unify and streamline workflows. Quality processes, such as document control, corrective actions, employee training and audit management, are digitized, automated and connected for improved efficiency.

What is eQMS enterprise quality management software?

You may have seen eQMS software referred to as enterprise quality management system software. Today’s eQMS platforms are scalable and flexible for small, mid-size and global enterprises alike. 

How does eQMS software work?

eQMS software works by integrating all quality processes, documentation and compliance requirements into a connected ecosystem designed to meet ISO, FDA and other regulatory standards.

Most eQMS software is cloud-based, providing secure, 24/7 access from anywhere in the world. Some vendors, like QT9, also offer on-premise solutions for businesses with localized infrastructure needs.

How can eQMS software help you?

If you’re aiming to achieve ISO, FDA or other regulatory compliance, or if you would like to improve operational efficiency, reduce risk and boost ROI, eQMS software can help. 

Some of the benefits of adopting eQMS software include:

Better, easier document control: Automating document control with eQMS software means no more paper logs or lost email approvals. Easily share controlled documents with specific teams, suppliers or customers while maintaining full version history and approval tracking. 

Automatic audit prep: Documentation needed for regulatory compliance is automatically generated, tracked and stored through its lifecycle. Many eQMS software solutions feature built-in audit management workflows to ensure readiness at all times.

Built-in efficiencies: eQMS software automatically generates next steps in your quality processes with interconnected applications, so tasks like risk assessments and supplier reviews are automatically generated. Features like email alerts, real-time dashboards and task automation eliminate bottlenecks. 

Real-time data: An eQMS serves as a repository for the most up-to-date data surrounding your quality operations – from the status of corrective actions to supplier evaluations. With a centralized, automated system, the latest data is always at your fingertips, ensuring decisions are made based on current information.

Competitive advantage: With streamlined workflows and faster time-to-market, an eQMS reduces costs, increases productivity and positions your business ahead of competitors. 
 

How does eQMS software help meet regulatory standards?

eQMS software helps multiple industries meet regulatory standards. In highly regulated industries, an eQMS enables you to meet and maintain compliance with ISO, FDA, GMP and other quality standards more efficiently. 

Key standards supported by eQMS software include:

  • Life Sciences: FDA 21 CFR Part 11 compliance for electronic signatures
  • Pharmaceutical Manufacturing: FDA 21 CFR Part 211 compliance for Current Good Manufacturing Practices (cGMP)
  • Medical Device Companies: FDA 21 CFR Part 820 compliance
  • General Manufacturing: ISO 9001 compliance
  • Medical Device Manufacturing: ISO 13485, EU MDR compliance
  • Environmental Management: ISO 14001 compliance
  • Laboratory Testing and Calibration: ISO 17025 compliance
  • Aerospace Companies: AS9100 compliance
  • Automotive Industry: IATF 16949 compliance
  • Food Storage and Handling: HACCP compliance
  • Food Safety: SQF compliance
  • Electronics Manufacturing: ISO compliance 

Software validation is a critical part of compliance for FDA-regulated companies, ensuring that all systems deliver consistent, documented results aligned with regulatory requirements. Many eQMS providers offer validation support, often at an additional cost. QT9 QMS is pre-validated at no extra cost.

How much does eQMS software cost?

eQMS software typically ranges from $2,000 per user annually to over $100,000 for enterprise-level, fully customized solutions. When evaluating platforms, consider: 

  • License costs (per-user vs. concurrent)
  • Scalability and modular add-ons
  • Implementation and onboarding fees
  • Training and support availability
  • Data storage and hosting limitations
  • Validation and maintenance costs

Licensing: The most common license types are per-user and concurrent. Per-user licensing is just as it sounds -- one license per individual user. Some eQMS software providers charge per user but offer pricing options based on functionality. For instance, if a user needs “read only” access, associated fees for that type of license will be lower.

Concurrent licensing allows companies to have multiple users on one licensing code. If a company purchases five concurrent licenses, then five of their employees can use the software at any given time.

Applications included: Many eQMS software providers offer pricing plans that start with a base of capabilities and increase in cost as extra capabilities are added. Make sure your non-negotiable functions are part of the core applications provided in the plan you’re considering and be aware of which applications are add-ons and at what cost.

Data limitations: You’ll also want to consider how much data the platform is able to store for you or if there are costs associated with different levels of data storage. Also note whether there are maximum data or document storage limitations.

Implementation and training: Be sure to find out if software implementation and training are included in presented costs or if there will be additional charges. Find out what kind of services are included in these services and at what cost. Sometimes training is free but limited, for instance, to on-line information libraries.

Additional fees: Be sure to ask about any other added fees, such as annual subscription fees or charges for software updates. Some eQMS software providers charge for customer support, for example. You’ll want to make sure you factor additional fees into your cost examination.

Scalability: Consider whether the eQMS software you’re considering offers applications that you can grow into as you either master other applications or as your business evolves and grows. Will there be an extra cost down the road when you need those capabilities? 

Tip: Look for solutions with transparent pricing and bundled modules to avoid unexpected fees as your business grows.

What is the best eQMS software for you?

The best eQMS software for you will depend on your organization's industry, compliance requirements and growth plans. Beyond core features, such as document control, risk management and corrective actions, advanced eQMS software also offers:

Electronic Signatures – Look for eQMS software that offers electronic approvals and signatures, for streamlined regulatory approvals and an automatic audit trail.

Audit Management – eQMS software should automatically schedule audits and notify you when due; should be able to audit against any regulatory standard; and should link directly to other quality processes, such as documents and corrective and preventive actions (CAPAs).

Scalability – Look for eQMS software that offers the ability to grow within the platform. While you’ll likely need document control from the start, other functions, such as automating supplier management, might be something you don’t currently need but can foresee being an asset as your business evolves.

Out-of-the-Box Capabilities -- Many eQMS software providers offer customization, which takes costs to a whole new level. Out-of-the-box eQMS software can provide robust capabilities for less and generally mean quicker implementation.

Comprehensive Support – As with any new software, there will likely be a learning curve. Look for an eQMS provider that will be there when you need help, whether its onboarding, software updates, over-the-phone support or a library of published instructions.

Full Validation – Software validation can be costly and time-consuming. Several eQMS software solutions, like QT9, include validation. Others offer it as an option. 

Summary

eQMS software is a powerful tool for businesses seeking efficiency, compliance and faster time-to-market. By automating workflows and providing real-time insights, it saves time, reduces errors and improves overall quality management. 

Explore QT9’s award-winning, cloud-based eQMS platform with over 25 built-in modules. Empower your team to work smarter by automating regulatory compliance, document control and other critical workflows with QT9 QMS. 

This article was originally published on January 25, 2024; updated July 25, 2025.

 
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FAQ: eQMS Software

What is eQMS software and why is it important?

eQMS software, or electronic Quality Management System software, digitizes and automates quality processes such as document control, audit management and CAPAs. It is important because it reduces errors, ensures compliance with ISO and FDA standards and improves operational efficiency. Businesses that adopt an eQMS can streamline workflows and bring products to market faster while maintaining compliance.

What industries benefit most from eQMS software?

eQMS software is ideal for highly regulated industries including life sciences, pharmaceuticals, medical devices, aerospace, automotive, food and beverage, and electronics manufacturing. It helps these industries comply with FDA 21 CFR Part 11, ISO 9001, ISO 13485, ISO 14001 and other regulatory requirements.

Is cloud-based eQMS software secure?

Yes. Cloud-based eQMS software uses advanced security protocols, data encryption and role-based access controls to ensure data privacy and compliance. Leading providers, such as QT9 QMS, offer secure hosting with 24/7 availability and regular system backups.

How does eQMS software help with FDA and ISO compliance?

eQMS software includes pre-configured workflows, electronic signatures, and automated audit trails that are specifically designed to meet FDA and ISO standards. For example, FDA 21 CFR Part 11 compliance for electronic signatures and ISO 9001 document control are built into many eQMS platforms.

Can small or mid-sized companies use eQMS software?

Absolutely. While eQMS platforms were once tailored for large enterprises, modern solutions like QT9 QMS are scalable and affordable for small to mid-sized businesses. You can start with core modules like document control and CAPA and expand with additional features as your business grows.

Why choose QT9 QMS over other eQMS software?

QT9 QMS is award-winning and trusted across multiple industries for its ease of use, cloud-based platform and 25+ built-in modules. It offers quick implementation, affordable pricing, FDA validation options and superior customer support, making it a top choice for organizations of all sizes.

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