Selecting an effective system to manage quality and compliance is essential for organisations operating across life sciences, pharmaceuticals and healthcare. With stringent regulatory requirements and significant risks linked to non-compliance, adopting a modern, streamlined quality system can boost efficiency, minimise errors, and play a vital role in safeguarding patient safety.
In this article, we’ll explain the core differences between QMS, eQMS, and eDMS with practical tips to help you decide what your organisation needs next.
What is a QMS?
A QMS (Quality Management System) is a formal framework that documents the processes, procedures, and responsibilities needed to deliver safe, high-quality products or services. For regulated scientific and healthcare industries, having a QMS is not optional but a legal requirement. A ‘traditional’ QMS can be either paper-based or loosely digital (think Word documents, spreadsheets, and emails) and will typically include documents such as:
- Quality policies and manuals
- Standard Operating Procedures (SOPs)
- CAPA (Corrective and Preventive Actions) logs
- Design and change records
- Training records
Who Needs a QMS?
A QMS is vital for any organisation legally committed to one or more regulatory bodies – such as the the FDA & EMA – who often demand the implementation of a QMS in order to gain product approval and market access. These requirements are in place for companies operating across the following sectors:
- Medical device manufacturers (ISO 13485, EU MDR, FDA 21 CFR)
- Pharma and biotech companies (GMP, GxP)
- Clinical labs and diagnostics firms
- Hospitals, clinics, and CROs
- Suppliers serving regulated industries
What is an eQMS?
An eQMS (Electronic Quality Management System) is a software-based platform that automates and streamlines quality management, going far beyond the manual processes of a standard QMS. It centralises all quality activities in a single, secure system, typically offering the following features:
- Automation: eQMS automates workflows for document control, CAPA, risk management, supplier oversight, and training – reducing manual effort and speeding up tasks.
- Compliance: Built-in features like electronic signatures and automatic audit trails help meet regulatory requirements (e.g., FDA 21 CFR Part 11, ISO 13485) with less effort.
- Traceability: All actions are tracked and searchable, making audits faster and reducing compliance risk.
- Efficiency: Standard QMS requires manual updates and reviews; eQMS sends automatic notifications, enforces deadlines, and provides real-time insight.
An eQMS offers superior control, compliance, and scalability over a traditional QMS. With features to help to automate workflows and track records, eQMS solutions help meet regulatory requirements, simplify audits, and minimise the risk of manual errors. But, adopting an eQMS can pose challenges. Some systems are inflexible and may require you to change your processes to fit the software, whilst implementation and training can be time-consuming and costly – particularly for smaller companies.
What is an eDMS?
An eDMS (Electronic Document Management System) is a typically a cloud-based platform with a primary focus on document lifecycle control. While an eQMS covers broader quality management, an eDMS specialises in storing, indexing, tracking, and controlling critical documents, including:
- Document version control with full audit trails
- Automated workflows for review, approval, and sign-off
- Integration of electronic signatures (compliant with FDA 21 CFR Part 11)
- Robust search and metadata tools for fast retrieval
- Change and design control features
Ways an eDMS Can Support a Quality Management System
Unlike eQMS deployments with can be bulky and complex, an eDMS is often more flexible, yet impactful, when it comes to strengthening your quality management system. For organisations, this can bring many benefits, including:
Centralised Document Control
An eDMS gives you a single, secure location for all your critical quality documents – SOPs, policies, validation protocols, product records, and training files. This reduces the risk of lost or outdated documents and makes information instantly accessible to authorized staff.
Automated Versioning and Audit Trails
Every change to a document is tracked automatically, with time-stamped records of edits, reviews, and approvals. This full audit trail is invaluable for regulatory inspections and internal audits.
Streamlined Collaboration and Approval Workflows
An eDMS automates review and approval processes. Documents are routed electronically to the right people, ensuring tasks are never missed and reducing bottlenecks.
Built-In Compliance Features
Features like electronic signatures, configurable access controls, and retention policies ensure your document management aligns with requirements from FDA 21 CFR Part 11, ISO 13485, and other standards.
Faster, Stress-Free Audit Preparation
When you can instantly search for and retrieve any document, audit preparation is much simpler. Auditors appreciate the clear, consistent structure, and you save time responding to requests.
Change Control and Continuous Improvement
Built-in change control workflows allow you to propose, review, and implement updates to SOPs and policies efficiently. This helps support a culture of continuous improvement.
Enhanced Training Management
An eDMS can track employee training records, ensure staff have acknowledged new procedures (“read and understood”), and provide proof of ongoing compliance competency.
Finding the Right Solution
Choosing between a QMS, eQMS, or eDMS will depend on a myriad of factors unique to your organisation.
For early-stage companies or those with simple operations, a basic QMS or a flexible eDMS may be sufficient to support compliance and manage key documents. But as your operations expand, your regulatory complexity increases, or you enter new markets, the need for automation and centralised control often points toward an eQMS.
The decision isn’t always straightforward – as each option comes with its own challenges and trade-offs.
For instance, traditional QMS solutions require significant discipline to maintain, while eQMS platforms demand investment and cultural change. It can be hard to determine which system aligns best with both immediate and future needs, especially when regulations, technology, and business models are constantly evolving. Implementation also presents obstacles. Moving to a new system may disrupt established processes and require thorough staff training, whilst resistance to change is natural – especially if users feel the new system is too rigid or doesn’t support how they work.
To make the best choice for you, start by mapping your unique workflows, understanding the regulatory landscape, and assessing both current and projected needs. Consider piloting new solutions in one department before a full rollout. Engage team members from different functions early in the decision and planning process, and allow time for structured training.
But finally, recognise that your needs will evolve. Flexibility, scalability, and vendor support should weigh heavily in your final decision.
Ready to Choose the Right System for You?
Choosing the right system for managing quality and compliance is a business-critical decision.
The regulatory landscape across life sciences, pharmaceuticals, and healthcare is unforgiving, and the risks of non-compliance include costly delays, reputational damage, and penalties. Regulators don’t care how you document quality – only that you do so in a way that is reliable, accessible, and audit-ready. The prospect of implementing or upgrading your current quality management system can be daunting. With many aspects to consider, and unforgiving regulations, you need to make sure that you get it right.
At The Knowlogy, we work with many organisations to help overcome the challenges with proper implementation of your quality management system. Whether that’s ad-hoc assistance, through to full implementation, we can find a solution that helps ensure compliance with the necessary regulations.
To discuss your challenges, get in contact to set up a free consultation for advice and support.