What is EDMS software?
Any regulated company looking to optimize its data and information processes will eventually encounter EDMS software.
In fact, an EDMS investment is among the handful of key software decisions a growing company will have to make.
But what is EDMS? How can one benefit your operation? And could other digital systems be a potentially better choice?
Let's dive in and take a look.
Table of Contents
EDMS meaning
There are enough acronyms to deal with in the business world, so let's start with the obvious: what is the meaning of EDMS?
What does EDMS stand for? It simply means 'electronic document management system'.
EDMS systems, also known as EDMS software, are digital platforms for the storage, maintenance and distribution of business documents.
In today’s digital age, businesses can be overwhelmed by an ever-growing volume of documents: SOPs, policies, work instructions, records.
Managing your documents efficiently, securely, and in compliance with your industry-specific regulations has become crucial.
This is where EDMS software, or electronic document management system software, can play a transformative role. From centralizing document storage to 'going paperless', enabling seamless collaboration and ensuring information security, a EDMS can be essential for modern operations — particularly in regulated industries like life sciences.
EDMS document management
Why manage your documentation in an EDMS system?
If you're using paper or adapted digital tools like SharePoint or OneDrive, you probably know the answer already.
Paper is easily lost and scattered, can't be properly controlled or scaled, and is unsuitable for companies operating a remote or multi-site set-up. In short, it's antiquated and old-fashioned.
And there are costs to consider, too. AIIM estimates that organizations with a heavily paper-oriented operation spend between $25,000 and a whopping $175,000 every single year just on paper production and usage costs.
Adapted digital tools, meanwhile, can't offer the levels of document and data integrity that highly regulated companies require. While they could be useful for a small, unregulated company like, say, a clothing manufacturer, they're inadequate for medical device or biotech businesses.
Consider, for instance, the typical document stack that a modern pharmaceutical company needs in order to meet its quality and regulatory demands:
Trying to manage these high levels of documents, with full traceability and version control, becomes almost impossible without a dedicated, purpose-built software platform.
Particularly when you consider these eye-opening stats about legacy document management systems:
It's here that EDMS document management comes into play — adding the all-important 'electronic' to your analog paper document management system, and transforming DMS into EDMS.
Key aspects of EDMS software
Because EDMS software is a type of platform specifically designed to manage the creation, storage, organization, retrieval and sharing of digital documents, EDMS document management allows for faster access, better security and improved collaboration among users.
Typical features include:
Digital storage: Most obviously, all your documents are stored in electronic format, reducing physical storage demands. Many EDMS platforms used to be on-premise, but nowadays it's far more common to encounter a cloud-based system that lets you access your documents from anywhere with an Internet connection
Indexing & searchability: Your documents are indexed with metadata, making them easy to find quickly using search functions
Access control: Permissions can be customized for individuals or groups to protect sensitive information, like employee records or senior leadership plans
Workflow automation: Repetitive document-related tasks such as approvals, reviews and archiving are partly automated with prompts, reminders and configurable workflows which cascade tasks among designated users
When selecting an EDMS, as with any business software investment, it's important to consider factors like:
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Industry-specific compliance needs
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Number of users and scalability
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Budget
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Any required integrations (e.g., CRM, ERP)
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On-premise vs. cloud preferences
Now let's look at the key features of a typical EDMS system in more detail.
EDMS software features
Looking to buy an EDMS for your company? It's helpful to understand the key features and functionality you can expect from any reputable platform. These features are what differentiate EDMS software from basic file storage tools like Dropbox or Google Drive.
Let’s break down some of the most essential EDMS features.
Version control
Version control ensures that document revisions are tracked and that your users always access the latest version. It logs every change made to a document, including who made it and when. This eliminates the confusion caused by multiple document versions being circulated via email or local storage.
Benefits of version control in your EDMS document management system:
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Staff only follow the latest and greatest versions of SOPs and operational documents: a vital element of modern regulatory compliance
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Allows point-in-time traceability of a document's evolution, showing how previous versions have changed as the documents moves towards its current form
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Ensures accountability for changes
Permission control
Permission control allows administrators to define who can view, edit, delete or share specific documents. This is crucial for protecting sensitive information and maintaining compliance with industry regulations like HIPAA, GDPR or FINRA.
Common use cases:
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HR documents accessible only by HR staff
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Legal contracts limited to authorized legal team members
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Client files restricted to account managers
With robust permission control, businesses reduce the risk of data leaks and unauthorized access, and ensure their information security has a solid foundation.
Audit trails
Traceable histories of document activity are vital for regulatory audits.
If you're in a regulated industry, your auditor will expect to see the full 'story' of a document, from drafting and collaboration to distribution and archiving. Any reputable EDMS software platform should contain audit trails to provide this information.
Collated automatically and easily accessible, EDMS audit trails are useful for:
- Tracking previous changes to a document
- Proving control and compliance
- Meeting regulatory standards - which all place strong emphasis on high-integrity document and data
Cloud-based access
Modern EDMS solutions are often cloud-based, providing anytime, anywhere access to documents via a secure web interface. This is particularly valuable for remote teams and organizations with multiple office locations.
Advantages of cloud-based EDMS systems:
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Supports remote work and mobile productivity
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No on-premise infrastructure or upkeep needed
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Offers scalable storage options
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Ensures automatic updates and security patches
Additionally, cloud EDMS platforms typically come with built-in disaster recovery and data encryption, giving your organization an extra layer of business continuity and information security maturity.
E-signatures
E-signature integration enables users to sign documents digitally within the EDMS environment. This accelerates approval workflows and eliminates the need for printing, scanning, or mailing physical documents.
Key benefits:
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If set up properly, compliant with electronic record regulations like FDA 21 CFR Part 11 and EU Annex 11
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Allows document actions to be attributed to individual users: important for meeting ALCOA+ requirements
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Gateposts key activities like signing off on documents, completing training on a document, or approving a document update
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Eliminates the need to invest in dedicated signature tools such as DocuSign (though not all EDMS systems have it - so it's best to check!)
E-signature functionality is especially useful in regulated industries where traceable, attributable action histories are critical for documents.
FURTHER READING: Why your life science business needs electronic document management
EDMS software FAQs
It's time for a quick recap.
Let's look at some frequently asked questions about EDMS software.
What is an EDMS?
As we've seen, an Electronic Document Management System (EDMS) is software that helps organizations store, manage, distribute and maintain electronic documents. It facilitates version control, access control, collaboration and regulatory compliance in a dedicated digital platform.
Why would my business need an EDMS?
If your organization struggles with lost documents, version confusion or slow document retrieval, an EDMS can help by centralizing document storage, automating workflows, improving your information security and data integrity, and simplifying compliance with industry regulations.
Does an EDMS improve productivity?
Usually, yes. AIIM estimates that in a paper-based DMS, your employees lose an average of 30 minutes every single day just searching for the documents they need to do their jobs. By eliminating time-consuming manual processes like searching through file cabinets or emailing documents back and forth, an EDMS enables teams to find what they need quickly and collaborate more efficiently — even remotely.
Is EDMS software secure?
Any reputable EDMS provider should have security at the core of their product. Modern EDMS platforms typically offer robust security features such as encryption, access logs, multi-factor authentication and permission management.
How does an EDMS help with compliance?
A good EDMS provides audit trails, document retention functionality and version histories that support compliance with standards like ALCOA+, HIPAA, ISO 27001 or the GDPR, depending on your industry and area of operation.
Leading document software providers, like Qualio, also offer pre-built, industry-specific document and workflow templates to accelerate your compliance maturity and get you audit-ready at speed.
Can an EDMS integrate with my existing systems?
As you'd expect, integrations are usually limited to other document tools.
EDMS solutions typically offer integrations with common platforms like SharePoint, OneDrive, Salesforce and cloud storage solutions to connect your information streams.
What's the difference between cloud-based and on-premise EDMS software?
Cloud-based EDMS software is hosted online, accessible from anywhere and maintained by your software vendor, making it easier to scale and cascade your document system. On-premise EDMS is installed locally, giving you more control over data but requiring internal IT resources and upkeep.
Cloud systems are now the far more common option, with on-premise platforms usually only used by organizations with absolutely airtight data security requirements, like defence operations.
EDMS examples
Now that you understand what EDMS software is and how it functions, let’s explore some real-world examples. These systems vary in features, pricing and specialization, catering to different organizational needs.
EDMS software list
Here’s a list of popular EDMS software platforms used by businesses today:
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DocuWare
A robust cloud-based EDMS known for its workflow automation, integration capabilities, and compliance features. DocuWare is widely used in HR, finance, and legal departments -
M-Files
Unique for its metadata-driven architecture, M-Files organizes documents based on what they are, not where they’re stored. It integrates easily with Microsoft 365 and other enterprise platforms -
Laserfiche
Offers comprehensive document management and business process automation tools. Its strengths lie in security, scalability, and analytics -
eFileCabinet
Designed for small to medium businesses, eFileCabinet is user-friendly and includes strong security, audit trails, and e-signature integration -
OpenText
Geared towards large enterprises, OpenText is known for its enterprise content management and compliance solutions, particularly in regulated industries -
Zoho WorkDrive + Zoho Docs
A budget-friendly alternative with solid document storage, sharing, and collaboration tools, suitable for startups and small businesses -
LogicalDOC
An open-source EDMS solution, LogicalDOC is great for tech-savvy teams looking for customization and cost-efficiency -
Qualio
More of an eQMS than a pure EDMS, Qualio contains all the functionality of an EDMS document management platform plus lots more on top, like training, quality process and supplier management functionality
EDMS vs. eQMS
Companies requiring both optimal document control and quality and compliance processes face a tricky choice:
1. Invest in one of the EDMS systems from our list and prioritize their documents and data
2. Invest in an electronic quality management system (eQMS), like Qualio at the bottom of the list, and modernize their entire quality approach
In fact, the line between EDMS software and eQMS software can get very blurred, since some systems, like Qualio, encompass both areas.
Whether you choose an EDMS system or a more holistic eQMS platform depends on the context of your business and your operational needs.
When to choose EDMS software
Why do regulated businesses opt for a dedicated EDMS document management system?
There are a few reasons:
- It’s cheaper: EDMS platforms do less, and therefore cost less, than a full-fledged eQMS
- It’s simpler: less functionality = less set-up and overhead time
- It’s better for smaller, less mature companies: your company may not have many other processes or operational elements in place which demand a more holistic platform
As we've already seen, there’s no doubt that moving from a paper-based document system, or one built on adapted tools like SharePoint or OneDrive, to a dedicated EDMS is beneficial for any regulated company.
All the perks of digital document management should come with any reputable EDMS.
That means you should expect the functionality we listed above: version and change control, cloud-based storage and retrieval, audit trails, e-signatures, and step-by-step workflows for tasks like review, approval, distribution and archiving.
For regulated companies who need to work to document standards like GDocP, ALCOA+ or FDA 21 CFR Part 11, EDMS document management can be a fantastic way to accelerate towards compliance – and to simply give yourself complete control and visibility of your document stack.
The tight focus of a EDMS has a knock-on benefit when it comes to
validation. Because EDMS systems are fairly rigid, and without layers
and layers of complex, configurable functionality, they can be validated
and launched into a regulated environment almost instantly.
This can be a considerable benefit if you need to upgrade your document
management system ASAP.
It’s worth noting, too, that the question of whether to digitize your
document stack or your entire quality system really comes down to the
operational maturity of your business.
If you’re a start-up in the earliest days of your operation, you might not have processes in place yet for things like staff training, quality events, medical device design controls or supplier management.
If you only have documents, it’s easy to make the case for only requiring an EDMS solution and nothing more.
EDMS cost
Ballpark figures naturally vary by vendor and the territory your
company operates in, but a good rule of thumb is that an EDMS software SaaS subscription typically represents a four-figure annual investment.
When to choose eQMS software
On the other hand, companies choose to invest in an electronic quality management system (eQMS) because:
- They’re more powerful: eQMS platforms offer far more functionality than an EDMS system, giving you the opportunity to upgrade your entire quality system at a stroke
- They’re futureproof: eQMS platforms offer a more comprehensive digital framework for all the quality/compliance processes you’ll need to execute, both now and in the future
- They’re better for established companies with existing processes (or plans) which warrant digitization
If EDMS software is a targeted, dedicated solution for a single business need, an eQMS is a more heavy-duty addition to your company’s tech stack.
Any reputable eQMS, including Qualio, will contain all the functionality of a modern EDMS system, plus lots more on top. That means as well as document management software, you can expect to manage suppliers, training, CAPAs, deviations, design controls, change controls and more within a single system – usually with much more flexibility and configuration than a standalone EDMS can provide.
As such, you could see some eQMS platforms as simply an 'EDMS plus more', with some overlap in functionality and a far more holistic toolset besides.
You should consider what you want to achieve with your EDMS vs. eQMS system investment.
If you’re a growing regulated company planning for the future, perhaps for a product launch and entry into a new market, there’s no way around it: you’ll need to establish processes for these key areas at some point anyway. If you opt for only EDMS software, the time will eventually come when you need to move to an eQMS regardless.
This could either leave you with multiple systems and sources of truth, or force you to ditch your EDMS system and to move your documents into the new eQMS.
Aligning your system choice with your medium- to long-term company plans is the best way to avoid this unnecessary effort and cost further down the line.
You should also reflect on the quality management system that your company will need to operate in its regulated environment. Documents are the baseline and cornerstone of any QMS, but in themselves are only markers or indicators of processes existing elsewhere in your company.
If you have documented processes, there’s a good chance those processes will benefit from being housed and executed in a dedicated electronic quality management system.
In a similar vein, an eQMS can provide key functionality your EDMS system can’t.
Although many EDMS systems offer basic analytics for things like document status and engagement, an eQMS sheds light on the performance of your entire quality system – from suppliers to CAPAs and deviations.
And although some EDMS software naturally offers integration with document tools like Office or Google Workspace, some eQMS platforms go further, connecting to your CRM, product development and ticketing tools as well.
These insights and integrations can offer critical support and guidance as your company grows and matures, often making an eQMS a more helpful investment than a standalone EDMS electronic document management system.
These benefits should be weighed up against the higher complexity levels of an eQMS.
Major eQMS platforms, like Veeva or MasterControl, can take many months to implement because of their validation and onboarding demands.
eQMS platforms also demand more training than EDMS software, meaning you probably can’t roll one out at the same speed.
On the other hand, eQMS platforms designed for small to medium companies, like Qualio, tend to offer faster implementation, validation and roll-out than competitors, with their greater focus on ease of use resulting in lower training barriers.
Choose a suitable eQMS, and you could therefore be up and running in a timeframe more like an EDMS.
And if you choose the pre-built document templates and workflows that some eQMS providers offer to accelerate your operational maturity, an eQMS could even deliver organizational impact for you in a shorter timeframe than if you chose EDMS software and then had to build your document stack manually.
eQMS cost
eQMS platforms usually cost more than an EDMS, but offer greater value in return.
If an EDMS software SaaS subscription typically represents a four-figure annual investment, an eQMS subscription usually falls into a five-figure one.
Enterprise eQMS platforms for major companies can even run into six figures.
The bottom line: EDMS software vs. eQMS software
Buy EDMS software if you:
- Are a small company with fewer than 10 heads
- Need to move away from your legacy document system almost instantly
- Don’t have (or require in future) more mature quality and compliance processes
- Only have a minimal (4-figure) budget
Buy an eQMS if you:
- Are an established company with 11 heads or more
- Want to upgrade your entire quality system – not just documents
- Want a more heavy-duty system for the long term
- Have a 5-figure budget
Get your guide: EDMS vs. eQMS: which is right for you?
If you really can't decide between the strengths and advantages of a EDMS software or eQMS software, opt for something with the best of both worlds.
Qualio's document management software sits within a broader eQMS, but is globally recognized for its ease of use, large suite of integrations, and powerful document management functionality.
Optimize your document processes - and the rest of your quality system - without compromise.
