Electronic Quality Management System (eQMS) Definition
An Electronic Quality Management System, or eQMS, for short, is a new digitalized approach to a Quality Management System (QMS). An eQMS is software that helps manage and document business processes for product development, quality, and compliance, across the organization in a paperless environment.
It is typically deployed on a cloud-based platform, accessible by all authorized users from anywhere, at any time.
The goal is simple: By automating quality management processes, businesses can improve product quality and ensure compliance while reducing costs and time to market.
QMS software solution helps businesses automate and streamline quality management processes such as document control, change control, employee training, supplier management, non-conformance/deviation management, CAPA management, customer complaint management, audit management, and more. An eQMS software solution can be used to manage quality and compliance across an entire organization spanning quality, regulatory, product development, and other departments.
We’ll expand on what eQMS exactly is, why organizations use such a tool and the elements of a good eQMS solution in more detail below.
Jump to sections:
- Electronic Quality Management System (eQMS) Definition
- What Is the Difference Between Electronic QMS and Enterprise QMS?
- Why Do Companies Use an eQMS System?
- How Does an eQMS Work?
- Essential Elements of a Good eQMS Software
- When Is the Right Time To Adopt an eQMS?
- How Much Does an eQMS Cost?
- Frequently Asked Questions
What Is the Difference Between Electronic QMS and Enterprise QMS?
When people talk about an eQMS, they usually refer to an electronic quality management system software, and this is how we will use the term throughout this article.
However, an acronym for EQMS can also stand for “enterprise quality management system”.
The latter is a broader term that encompasses an organization’s total approach to quality management, of which a typical eQMS software is just one part.
Since SimplerQMS provides broad QMS process support and follows the total QMS approach, we also consider ourselves as an Enterprise Quality Management System provider.
Why Do Companies Use an eQMS System?
Organizations use electronic quality management systems for many reasons, but the overall goal is to improve quality, reduce costs, increase efficiency, and ensure compliance with applicable regulatory requirements.
In the context of life science organizations, operating in industries like medical devices, pharmaceuticals, biotech, and others, the requirements of a Quality Management System (QMS) are defined by regulations, standards, and guidelines such as:
- ISO 9001:2015
- ISO 13485:2016
- FDA 21 CFR Part 820
- ISO 17025:2017
- ICH Q10
- EU MDR & EU IVDR
Here is an illustration of the main regulatory requirements that could apply to medical device and pharmaceutical organizations.
The goal of a QMS is to help organizations design and formalize a system that documents and controls their processes, so they can produce safe and effective products that meet customer requirements and regulatory standards.
Traditionally, Quality Management Systems have been implemented using paper-based methods, which are often inefficient and can lead to errors.
An eQMS system helps businesses overcome these challenges by automating quality management processes, making it easier to track and manage data, documents, and workflows.
A good way to determine if your organization would benefit from an eQMS is to ask yourself if you are struggling with any of the following challenges using a paper-based or hybrid QMS, which an eQMS system aims to solve:
- Limited traceability of documents and processes
- A high number of progress check meetings
- Lack of access to the paper archive
- The burdensome and challenging design transfer process
- Complicated risk management and risk analysis
- High risk of misfiled or lost documents
- Obsolete and out-of-sync records in circulation
- High risk of missing signatures
- Lack of accountability and visibility within teams
- Hard to keep up-to-date design documentation throughout the product lifecycle
- Ineffective and lengthy document authoring processes
- High costs connected to inefficiency, human error, and corrective measures
Do you find yourself facing one of these issues?
If so, an eQMS system might be the right solution for you.
It is easy to use, pre-configured, pre-validated, compliant out-of-the-box, and can be implemented quickly.
To learn more about how SimplerQMS can help your organization, request a personalized demo.
How Does an eQMS Work?
An eQMS systems start by connecting all the quality-related processes and data in an organization in a single system. It provides a centralized repository for all documents and data, making it easy to manage your business processes and workflows, so you can streamline quality and compliance.
Controlled document workflows, QMS process support, electronic signatures, automated notifications and reminders, and real-time visibility into the progress of the tasks are some of the core features of a digital QMS.
In practice, an eQMS should make it easy to do the following:
- Create, edit, review, approve, and archive documents
- Sign off documents using electronic signatures
- Control document versioning as well as access, based on user roles and permissions
- Track and manage quality events, such as non-conformances, customer complaints, audit findings, and CAPAs
- Streamline other QMS processes, such as employee training, change control, design control, risk management, equipment calibration, supplier management, and others
- Generate reports, and analyze quality data to identify trends and areas for continuous improvement
- Plan, schedule, conduct, and document quality audits
- Help ensure compliance with quality standards
A good eQMS should work with the way your organization already operates and be flexible enough to adapt as your needs change.
There are many eQMS solutions out there, but not all of them are created equal.
But there is likely an eQMS system that’s the right fit for your organization. SimplerQMS is an example of an eQMS software purposefully built for life science organizations. The system supports core processes relevant to the industries, such as document control, design control, change control, supplier management, training management, audit management, and many more.
Essential Elements of a Good eQMS Software
Now, let’s take a look at some of the essential elements of modern QMS software.
QMS Process Support
First, you will need to make sure that the eQMS software you choose supports all of the quality processes that are relevant to your organization, such as:
- Document Control
- Change Control
- Training Management
- Supplier Management
- Design Control
- Risk Management
- Audit Management
- Non-Conformance Management
- CAPA Management
- Support for other processes, that might be relevant to your business
The number of features and services offered by different QMS software providers is vast and it’s easy to get overwhelmed. So, we created a free eQMS software comparison template, which you can use to compare different software vendors and find the solution that best meets your needs.
Compliance With FDA 21 CFR Part 11
If you’re in the life sciences industry, then you need to make sure that the eQMS software you choose is compliant with FDA 21 CFR Part 11.
This regulation sets forth the requirements for electronic records and signatures, and establishes the criteria under which they are considered trustworthy, reliable, and generally equivalent to paper records.
To learn more about this regulation and its requirements, check this article on the FDA 21 CFR Part 11 requirements.
Another important element to look for in eQMS software is whether it is pre-validated.
If you’re in the life sciences industry, then you know that validation is a process that ensures that your computer systems and software meet FDA requirements and that they’re fit for their intended purpose.
Make sure to ask an eQMS vendor how validation is performed and who takes care of this task!
Ensuring that the system is continuously validated when the software changes can be a challenging, time-consuming, and expensive process.
One way to avoid this is to choose a pre-validated eQMS software that comes with a validation package and continuous validation services from the vendor, like SimplerQMS.
To learn more about this topic, check out this article on QMS software validation and when it is needed.
Avoid Digital Archives That Are Not Validated
If you currently have some type of a hybrid QMS system in place, with both paper and electronic records, then you might already be using some file server services like Dropbox, SharePoint, or Google Drive. The problem with these is that services are not necessarily meant for keeping and controlling digital records, especially for organizations in the life science industries.
They often lack the necessary certifications and validation.
Using non-validated software to handle your records and documentation is the quickest way toward non-conformances.
It’s tempting to use these alternatives instead of a purely paper-based QMS. They offer easier accessibility to your documentation but one of the main issues is that many services are not compliant with FDA CFR 21 Part 11 software requirements, which could lead to serious consequences for your business during audits and inspections.
So, if you’re using any of these file-sharing services in your life science organization for keeping and managing your quality documentation, we recommend that you switch to a software solution that is FDA 21 CFR Part 11 compliant.
The next thing you need to consider is whether an eQMS will help you assure regulatory compliance. So, you should check for compliance with the standards, regulations, and requirements applicable to your business, for example:
- ISO 27001:2013
- ISO 27018:2014
- ISO 9001:2015
- ISO 13485:2016
- FDA 21 CFR Part 820
- FDA 21 CFR Part 11
- ICH Q10
- GAMP 5
- EU Annex 11
- EU MDR and EU IVDR
These guidelines provide needed security and standardized regulatory requirements for Quality Management Systems.
To learn about Quality Management Systems and their requirements in various life science industries, explore the following articles:
- Pharmaceutical Quality Management System
- Medical Device Quality Management System
- ICH Q10 Pharmaceutical Quality System
- Clinical Quality Management System
- Laboratory Quality Management System
Lastly, you should also be mindful of how the eQMS will be deployed within your organization. In other words, you will need to find out what are the hosting options of the solution.
Non-cloud-based (on-premise) options will usually require you to set up your own servers and IT staff which might end up only increasing your costs.
On the other hand, cloud-based eQMS systems are often more affordable and easier to set up since they don’t require any special hardware and dedicated IT resources.
Such a deployment model allows users to access the system from any device and location. Cloud-based eQMS systems are often updated more frequently than on-premises solutions. So, you can be sure that you’re always using the latest software version and that your data is backed up and secure.
Plus, cloud-based solutions can be quickly deployed and scaled to meet the needs of a growing business, and are therefore often the preferred choice for smaller businesses and growing startups.
Apart from the factors we’ve already mentioned, you should also have in mind a few other considerations when choosing an eQMS, such as:
- How long does it usually take to implement the system?
- What support can I expect after the solution has been implemented?
- What kind of training material is available?
You can read more about this topic in our article about how to choose the right QMS software for your organization.
When Is the Right Time To Adopt an eQMS?
Before investing in an eQMS solution, you should first have developed a QMS or be in the process of implementing one.
Once you have a QMS in place (or are in the process of developing it), you can start thinking about streamlining and automating your processes with an eQMS when:
- You’re using multiple spreadsheets, paper documents, or various software solutions to manage your quality processes
- You need to improve communication and collaboration within your quality department
- You need to automate and streamline your QMS processes, to improve efficiency, and reduce costs
- You need to improve compliance with regulations and standards
- You need better visibility into your quality data
- You need a solution that is scalable and flexible to accommodate your company’s growth
If you can relate to any of the above, then it’s probably time to start looking for an eQMS solution that will help you take your quality management to the next level.
How Much Does an eQMS Cost?
The price of electronic quality management systems ranges. There’s not a one-size-fits-all answer. Therefore, many eQMS providers tailor their pricing models to the specific needs of each customer.
The main cost factors of an eQMS include:
- The number of users: Many eQMS providers charge based on the number of users that need access to the system. The price per user usually decreases as the number of users increases.
- The number of QMS processes, or modules, you need: Some eQMS solutions offer a variety of modules that support different QMS processes. Such vendors usually charge based on which modules you need.
While the factors of eQMS pricing can be complex, the good news is that the barriers to entry for eQMS software have never been lower.
The main reason we offer SimplerQMS as an all-in-one eQMS software solution for one subscription price (depending on the number of user licenses) is to ensure that quality management is accessible and affordable for businesses of all sizes.
This means that all QMS modules, implementation, training, ongoing support, updates, cloud-based hosting, and more are included in the QMS software pricing. There are no hidden costs or unexpected fees, which makes it much easier to budget for an eQMS solution.
Frequently Asked Questions
What Is an eQMS?
An electronic quality management system (eQMS) is a software solution that helps organizations manage and improve their quality management processes, increase efficiency, reduce costs and ensure complaince.
This system is accessed and maintained electronically, which allows for real-time collaboration and communication between quality managers, employees, and other stakeholders.
What Does an eQMS System Do?
An eQMS system streamlines and automates quality management processes like document control, change control, non-conformance, CAPA, audits, training, supplier management, and more.
Typically, an eQMS will store quality-related documents and data in a central repository, which can be accessed and updated by authorized users from anywhere in the world. Different departments within an organization can use an eQMS to collaborate on quality-related tasks, ensuring that everyone is on the same page and working towards the same goal.
What Are the Benefits of an eQMS?
There are many benefits to using an electronic quality management system, including improved communication and collaboration across the entire organization, automation and streamlining of QMS processes, improved compliance with regulations and standards, better visibility into quality data, reduced costs, and improved efficiency.
How Do You Validate an eQMS?
You validate an eQMS by executing test scripts and ensuring it is working as intended. The entire process is documented according to the process for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
By choosing SimplerQMS as your eQMS vendor your organization won’t need to validate the system to comply with ISO and FDA regulations concerning system validation. We provide the system in a pre-validated state and perform continuous re-validation.
An electronic quality management system is a powerful tool that can help organizations to improve quality and compliance, increase efficiency, and reduce costs.
It outperforms traditional paper-based quality management systems in many ways and is quickly becoming the new standard for quality management across all industries.
If you’re looking for a way to take your quality management to the next level, an eQMS may be the right solution for you.
SimplerQMS offers a cloud-based eQMS software solution designed specifically for the life science industries. Request a demo today to learn more.