There are different ways companies can build required quality management systems, from using traditional paper-based solutions to deploying modern heavy-duty eQMS software. But what's the difference between these options? What's the best way to define and embed quality processes and procedures across your operations?
A quality management system (QMS) is a formalised framework for documenting the quality processes, procedures, and responsibilities that help you build safe and reliable products in the most efficient way.
It can be digital or paper-based, but a QMS should be designed to help organisations coordinate all their activities to meet customer expectations, quality standards and regulations.
▶️ WATCH: In this video medical device quality expert Sam Shelley explains why an electronic document management system (EDMS) should sit at the heart of every medical device developers’ quality system:
Having a formal quality management system is a requirement in many sectors where safety and quality are paramount - from aeronautics and automotive, to pharmaceuticals and medical devices.
In these industries, government bodies expect companies to have quality systems that conform to the relevant standards and regulations before they can legally sell their products.
This blog post will focus on the way Quality Management Systems are currently deployed in the medical device sector.
Standards and regulations that can apply in this sector include:
Many quality management systems (particularly in the medical device industry) still remain paper-based, operating as a system of indexed, real-world files that contain:
In a paper-based system files are kept up to date manually and used for onboarding, record keeping, investigations, and internal and external audits. Regulators and their notified bodies audit these paper records in person before issuing/revoking certifications or sending warning letters requiring remedial action where necessary.
The drawbacks of paper-based systems are well understood. They require a lot of discipline, time and resource to keep up-to-date and used effectively by your workers. Because they are reliant on manual upkeep, the risk of obsolescence, omissions and mistakes always hangs over them.
But while quality professionals were once required (literally) to shuffle paper, now they have the opportunity to use digital tools to deliver leaner, more effective and automated systems which can better deal with growing complexity and risk. They can also increase their efficiency and velocity in delivering the innovation their industries demand.
Trying to do things digitally comes with its own set of risks. The different servers, apps and messaging systems that dispersed modern companies use every day can fragment communication and record-keeping. The use of Google Drive, email, Slack, Zoom, OneDrive, and countless other platforms to share and store vital documentation (like designs, plans, specification, change requests) often threatens process, consistency, and accountability.
Trying to build a digital QMS stitched together using Google Drive, Excel, and other platforms is notoriously difficult, and it can make auditing a nightmare.
Instead, eQMS (electronic management systems) are there for industries who want to use a single digital platform to store and administer all their quality activity and meet increasingly rigorous compliance demands.
A QMS is a centralised record of all your quality processes and documentation that can be either paper based or digital. An eQMS is a proprietary digital platform that uses templated SOPs and workflows to help you structure a compliant development and product management process.
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PAPER-BASED QMS |
DIGITAL QMS |
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eQMS are single platform, enterprise quality management software designed to help modern businesses deliver complex products. They are often used in large, international companies (working in heavily regulated sectors like life sciences) to try and ensure conformity and accountability across dispersed teams working on lengthy projects. In the life science sector popular platforms include:
For a more detailed overview of the pros and cons of each system, you can check out our comparison of the best eQMS software on the market.
eQMS solutions in life science companies often support 'hard' quality management. They bring various technical tools designed to control design and production processes to achieve specific standards.
They typically bring templated and modular solutions to automate:
With a focus on improving standards through the rigid adherence to procedures within a business, QMS software solutions are often initiatives 'imposed' across an organisation by a quality management function.
These solutions bring with them workflow templates for compliant SOPs that their customers are required to use. Businesses often have to restructure the way they work to meet the demands of the vendor system. With little flexibility in the way they operate, complaints, non-conformances, CAPAs and other procedures all have to be dealt with in fixed ways that can require changing your operations and retraining staff.
An eQMS might mean installing software packages across a network by specialist contractors that take weeks or months to complete. Once installed, they might require lengthy training and troubleshooting to integrate into your operations.
eQMS can be unpopular with workers who have to use them. Sometimes, businesses implement solutions that end up never being installed or used correctly, causing problems further down the line with auditing and compliance.
Sometimes they end up paying considerable sums to have these systems reconfigured entirely to suit the way they work.
As quality consultant Sam Shelley wisely puts it:
“There are two different types of EQMSs. There's the EQMS where a system is going to dictate how you are going to operate. And there's the EQMS where you pay an awful lot of money to have it configured to match your processes.”
A DMS or an EDMS (Electronic Document Management System) is a digital framework for file storage that can be used to structure and control documentation in any way a business needs These systems offer robust but flexible tools that can be used to define and impose the controls over documents and processes required by ISO 9001, ISO 13485, the FDA QMSR (Quality Management System Regulation) and FDA 21 CFR Part 11.
An eDMS is, typically, a cloud-based platform into which you can migrate all your existing quality documentation to build a digital QMS. It can help you:
From when they are created to when they are archived. They can automate the labelling, storage, and structure of documentation for easy navigation, indexing and discoverability.
An eDMS designed for quality professionals in medical devices might bring with them preconfigured workflows for mandatory SOPS, but (unlike an eQMS), they come with the tools to adapt them to reflect your unique process.
The right DMS comes with flexible tools to set up necessary engineering change control processes, and phase gating for controlled design systems.
A DMS will help you automate processes to keep documents following through the system, ensuring required reviews and approval events are never missed.
An EDMS can automatically create auditing trails for all your documentation, showing version histories, changes and approvals.
The right system can integrate s-signatures into your process, allowing you to sign off documentation in ways that exactly reflect the regulation (e.g. FDA 21 CFR part 11)
With flexible and adaptable controls and SOPs you can adopt and adapt the way you work overtime.
With your eDMS operating as a single source of truth for the way you work and develop your products, robust search and navigation tools will help you answer all your auditors' questions.
There's a world of difference between the kind of quality outcomes and pace of development you can achieve with paper-based systems versus a digital QMS system. But for scaling businesses, a one-size-fits-all eQMS solution can be a strait-jacket rather than a solution.
An eQMS can be a heavy-duty and expensive option that imposes particular ways of working onto a business. Sometimes it can only make sense for larger companies to spend the time and effort deploying them and pay extra for customisation when they need it.
But a LEAN eDMS can operate as a flexible digital framework for those businesses who need to manage and control their documentation, people and process in ways that work for them.
With the right controls, these companies can build out systems that answer the requirements of the most stringent regulation while not getting bogged down with unnecessary bureaucracy.
The right eDMS, can become a central tool for induction, training and ongoing optimisation of process and procedure - a 'single source of truth' to which a whole company can contribute and refer. As an easily accessible and searchable tool, an eDMS can also make the process of quality audits quicker and less stressful.
Blog post updated on 18/02/2025