What is eQMS Software and How Can It Help You?
January 30, 2024
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.
eQMS software can centralize and connect quality processes and automatically create traceability, eliminating misplaced documents and overlooked tasks. Here we explore eQMS software and how it can impact your quality management operations and your business.
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. eQMS is an acronym for electronic Quality Management System software, also called QMS software.
If your quality management system consists of paper-based binders, spreadsheets and file cabinets, eQMS software can unite those diverse methods into one, single source of truth. Quality processes, such as document control, corrective actions, employee training and audit management, are automated, connected and made more functional through eQMS software.
What is eQMS enterprise quality management software?
You may have seen eQMS software referred to as enterprise quality management system software. In the past, the term referred to quality management systems built for very large operations. Today, however, it has become synonymous with electronic quality management system. Solutions are available for any size organization.
How does eQMS software work?
eQMS software works by connecting quality processes and documents to meet the requirements of various ISO and ISO-derived quality standards.
eQMS software is typically cloud-based, meaning that it is stored, managed and available through the internet. Cloud-based eQMS software is accessible anytime, anywhere. Some eQMS software companies also offer an on-premise eQMS solution, where the software is installed and run on a local server and managed on site.
How can eQMS software help you?
If you’re striving to achieve ISO, FDA or other regulatory compliance, or if you would like to improve efficiency for overall performance and bottom-line success, 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. Improve accessibility by sharing controlled documents with specific locations, users, suppliers or customers. Approvals are tracked electronically with a timeline that enables you to gain full traceability.
Automatic audit prep: Documentation needed for regulatory compliance is automatically generated, tracked and stored through its lifecycle. Many eQMS software solutions have embedded processes for meeting strict regulatory standards.
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. Users can also take advantage of useful aids, such as to-do lists, email reminders and automatic scheduling.
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.
Stay ahead of competitors: With an eQMS, quality becomes ingrained in your operations and efficiencies are reached throughout your organization, allowing you to bring your products to market more quickly. Saving time and money can put you far ahead of your competitors.How does eQMS software help meet regulatory standards?
eQMS software helps multiple industries meet regulatory standards. For highly regulated industries, software can be the means to efficiency that puts you ahead in an extremely competitive arena. A good eQMS software solution enables organizations to easily achieve ISO and FDA compliance.
Software validation is a critical process for all companies that must comply with FDA regulations. FDA software validation occurs when an FDA-regulated company demonstrates and documents that its software can accurately and consistently produce results that meet predetermined guidelines for compliance and quality management. Validation via eQMS software is typically available at an extra cost.
A good eQMS software is tailored to help meet good manufacturing practices (GMP) and FDA and ISO standards, such as:
- Life Sciences: FDA 21 CFR Part 11 compliance for electronic signature approvals
- 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 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
How much does eQMS software cost?
eQMS software typically ranges from $2,000 per user, per year to hundreds of thousands of dollars per year for a highly customized solution. When choosing an eQMS, pay especially close attention to the following factors:
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Cost per license
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The number and type of licenses your organization requires
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Scalability of the platform
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The number of modules/applications included
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The cost to add modules or features
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Data limitations and costs
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Implementation timing and costs
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Training and support costs for current and future employees
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Validation costs
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Maintenance, subscription or other added fees
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?
What is the best eQMS software for you?
The best eQMS software for you will depend largely on your business needs. Beyond standard, core quality management features, such as document control, risk management and corrective actions, an advanced eQMS software also offers:
Electronic Signatures – Look for eQMS software that offers electronic approvals and signatures, easily satisfying regulatory standards and creating an automatic audit trail.
Regulatory / 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.
Validation – Organizations focused on life sciences, medical devices and pharmaceutical products should consider using a validated eQMS. Software validation can be costly, and several eQMS software solutions offer validation as an option.
Summary
eQMS software is a powerful tool for organizing, connecting and streamlining your quality processes. It can save you time and money by improving efficiency and reducing the amount of time it takes to bring your product to market.
Explore QT9’s award-winning, cloud-based eQMS solution that offers 25-plus modules standard. Empower your staff to be more productive by automating workflows and regulatory compliance across operations with eQMS software.
