By Andrew Holland
Andrew has worked in the compliance management software industry since 2000 and has worked with hundreds of companies and compliance professionals in multiple sectors across environmental, health and safety management and the views and content below is drawn from those encounters from across more than two decades.
Co-founding Syncronology (now Singlepoint) in 2005, Andrew has been a driving force behind Singlepoint’s development, focusing on aligning the product with market needs and ensuring it delivers tangible value to customers.
Definition and purpose of a Quality Management System
A Quality Management System (QMS) is commonly defined as the framework an organization uses to manage quality.
Because of the use of the word “system”, we sometimes assume QMS = IT System. In reality, when organizations refer to their “QMS”, they are often describing a broad collection of practices and tools rather than a single, coherent system. The system is the combined weight of organizational objectives, policies, procedures, instructions and some kind of management methodology is applied to operate it.
This distinction is important, because it explains why the term eQMS has become increasingly prevalent. As digital traceability and evidence expectations increase, particularly in advanced industries like automotive and medical devices, digitally managing the QMS is an expectation.
Essential Elements of a QMS
What are the essential elements of the system?
Quality Objectives and Policies
This is the heart of the QMS, providing clear direction and standards for quality. They articulate the organization’s commitment to quality and set measurable goals, guiding all other QMS activities.
Documented Procedures and Processes
Comprehensive documentation is crucial for consistency and standardization. It includes detailed descriptions of processes and procedures, which serve as a reference point for employees and help in maintaining uniformity in quality across all operations.
Roles and Responsibilities
Clearly defined roles and responsibilities ensure that each team member knows their specific duties related to quality management. This clarity is vital for accountability and the smooth functioning of your QMS.
Data Management and Analysis
Effective collection, management, and analysis of data are essential for monitoring performance and identifying areas for improvement. This element enables informed decision-making and supports continuous quality improvement.
Customer Focus
Prioritizing the needs and expectations of customers is key. A customer-focused approach involves gathering and responding to customer feedback, ensuring that products and services meet (or even better, exceed) customer requirements.
Continuous Improvement
An integral part of a QMS is the commitment to ongoing improvement. This involves regularly assessing and enhancing processes, policies, and objectives to improve quality and adapt to changing conditions or requirements.
What Is an eQMS?
An eQMS (electronic quality management system) is a purpose-built software platform designed to digitally manage and execute the processes that underpin a QMS.
Unlike shared drives, spreadsheets or generic collaboration tools, an eQMS is intended to:
- Run quality processes through defined workflows
- Apply rules automatically
- Maintain audit trails by default
- Ensure controlled information is available at the point of use
Digitally managing a QMS is no longer unusual. In many environments, it is now the baseline expectation, which is precisely why the distinction between QMS and eQMS matters.
For an eQMS to be meaningful, it must be software-driven and process-led, not simply a digital filing system.
In practical terms, this is what separates an eQMS from earlier forms of “digitised QMS”, such as SharePoint libraries or Excel trackers.
Purpose‑built systems like Singlepoint help execute processes dynamically rather than relying on people to remember what to do next.
What a “Traditional QMS” often looks like today
Even in organizations that consider themselves digitally mature, traditional QMS approaches frequently rely on:
- Excel trackers for CAPA, non-conformances or actions
- Documents stored in shared drives or SharePoint
- Manual approvals and email chasing
- Audit evidence assembled retrospectively
- Limited or no integration between quality processes
Partial digitisation often leaves manual practices intact (particularly around tracking, reporting and follow-up) which creates hidden fragilities as organizations grow.
These approaches may function adequately at a small scale, but their limitations become more visible under pressure.
When traditional QMS approaches start to fail
As organizations scale, quality systems are expected to do more with less tolerance for error.
Methods that rely on manual control tend to degrade as headcount increases, sites multiply or scrutiny intensifies. Control is gradually replaced by assumptions, informal knowledge and trust that things are being done correctly.
At this point, teams are often forced into a trade-off:
- Follow the system and slow down operations, or
- Keep operations moving and retrospectively “catch up” the system
In reality, the latter usually wins. People know it’s only a matter of time before something goes wrong, but the system gives them no practical way to prevent it.
Organizations may find themselves sleepwalking into a quality issue.
Why organizations move towards eQMS
Across regulated and operationally complex environments, several factors commonly trigger a reassessment of quality systems.
Audit and Compliance Pressure
Findings from customer or surveillance audits often expose weaknesses in document control, traceability or accountability that manual systems struggle to address consistently.
Quality Incidents
Significant non-conformances or quality failures that should have been prevented by the QMS tend to accelerate the move towards more robust, system-led control.
Change and Growth
New leadership, organizational restructuring or rapid growth frequently highlight that the existing QMS reflects how the organization used to work, not how it operates today.
Evolving Standards
Periodic updates to standards particularly, in the US market, where evolving ISO requirements increasingly sit alongside FDA, AS9100, IATF 16949 or customer-specific regulatory expectations
What a Modern eQMS Is Expected to Deliver
When organizations describe what they want from an electronic QMS, the same underlying requirements tend to emerge.
Control, visibility, automation and centralisation consistently sit at the top of the list.
Workflow-led automation
A modern eQMS executes quality processes through defined workflows rather than manual coordination.
Automation in this context is not about removing people from the process, but about ensuring tasks are triggered, routed and followed up consistently without relying on individual memory or effort.
This is fundamentally different from static trackers. For example, an Excel‑based CAPA log can record actions, but it cannot assign tasks dynamically, enforce sequencing or escalate issues automatically.
Examples include:
- Automated task assignment
- Role-based approvals
- Time-based reminders and escalations
Audit trails as a by-product
One of the most significant shifts introduced by eQMS platforms is that audit trails are created automatically as work is done, rather than assembled under pressure after the fact.
This dramatically reduces audit preparation effort and improves confidence in the evidence presented. The record is an outcome of the process, not a reconstruction of it.
Document Control as the foundation
For many organizations, document control is the most logical starting point.
Document management and control is often the area where the benefits of moving to an eQMS are felt most immediately and most broadly across the workforce.
Effective electronic document management ensures:
- A single source of truth
- Controlled access and distribution
- Clear ownership and revision history
Uncontrolled printing, unauthorized edits and outdated documents circulating in operational areas are common failure points in traditional systems.
Linking documents, training and competence
In most regulated environments, documents are the primary vehicle for conveying how work should be done.
An effective eQMS creates explicit links between procedures, training requirements, training materials and individual competence, down to document revision level.
Competence management closes the loop: it provides verifiable evidence that people have not only been trained, but have understood and acknowledged the requirements that govern their work.
Where modern eQMS platforms differ most
One of the most common mistakes in QMS digitisation is simply recreating existing processes in software.
Digitisation creates an opportunity to reassess workflows, challenge non-value-adding steps and embed best practice directly into the process.
Flexible eQMS platforms allow workflows to be adapted as:
- Roles change
- Teams evolve
- Responsibilities shift
The workflow endures even as the organization changes around it. Maintaining control without introducing rigidity.
Implementing an eQMS Successfully
Technology is rarely the main barrier to success in our experience.
Effective eQMS implementations are typically led by clear internal ownership and a phased approach, rather than attempting to digitise everything at once.
A common pattern is:
- Start with document management
- Expand into areas such as audit, CAPA or training
- Introduce additional modules over time
Incremental adoption consistently outperforms over-engineered, all-at-once deployments.
What to Look for in eQMS Software
When assessing QMS software, organizations should focus on:
- Configurability – can workflows reflect how the business actually operates?
- Scalability – will the system continue to work as complexity increases?
- Integration – can it connect sensibly with other operational systems or data where required?
- Usability – is the system intuitive and able to display the right information at the right time to the right person
- Evidence – are there credible examples of the system working in comparable environments?
The ability to prove fit through real use cases and hands-on evaluation is often more valuable than feature lists.
AI and the future of eQMS
As eQMS platforms continue to evolve, Generative AI is starting to play a practical role in reducing friction across quality and document management, particularly in areas such as document drafting, summarisation, translation and content reuse.
In regulated environments, the value of AI lies less in autonomous decision-making and more in supporting time-intensive tasks while preserving human oversight, validation and approval.
Used well, AI rewards strong structure and governance. It often exposes weaknesses in document quality, metadata and control that were previously tolerated, making disciplined systems even more valuable.
For a deeper look at how AI is being applied responsibly within controlled quality systems today, see our article on AI in document management.
