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?
What's a QMS?
A quality management system (QMS) is a formalised system that documents the processes, procedures, and responsibilities for achieving a company's quality policies and objectives.
A QMS coordinates and directs an organisation's activities to meet customer and regulatory requirements.
Who needs a QMS?
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 quality challenge within the life science industry.
Standards and regulations that can apply in this sector include:
- ISO 13485:2016 - specifies QMS requirements for medical device developers
- ISO 9001 - international quality standard for production and service industry
- EU MDR - EU medical device regulations
- EU IVDR - EU In Vitro Diagnostic Device Regulation
- FDA 21 CFR Part 820 - the US medical device regulation
- FDA 21 CFR Part 11 - the US medical device regulation for electronic quality management
Many quality management systems (particularly in the medical device industry) still remain paper-based, operating as a system of indexed, real-world files containing:
- Quality policies and manuals
- Standard Operating Procedures (SOPs)
- Records of design and development activities
- Non-conformance reports
- CAPA records
- Other mandatory documentation.
QMS: Why paper isn't working
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.
Digital to the rescue?
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.
But 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. Everything that is central to good governance and quality management.
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.
QMS: Why digital beats paper for medical device developers
What's an eQMS?
eQMS are single platform, digital quality management solutions designed to help modern businesses deliver quality 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:
eQMS solutions in life science companies often support 'hard' quality management. They offer various technical tools designed to control design and production processes to achieve specific standards.
With a focus on improving standards through the rigid adherence to procedures within a business, eQMS solutions are often initiatives 'imposed' across an organisation by a Quality Management function.
Drawbacks of heavyweight eQMS solutions
The solutions bring with them workflow templates for compliant SOPs that their customers are required to use. This means 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.
Often criticised for having clunky interfaces, inflexible configuration and taking a 'box-ticking approach' to compliance - 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.
They can also come with a pretty hefty price tag.
What's an eDMS?
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, FDA 21 CFR Part 820 and 11.
8 ways an eDMS can help you build a Quality Management System
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:
1. Control the lifecycle of your documents
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.
2. Enable bespoke workflows for your unique processes
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.
3. Enforce change and design control
The right DMS comes with flexible tools to set up necessary engineering change control processes, and phase gating for controlled design systems.
4. Sends notifications for document approval and review
A DMS will help you automate processes to keep documents following through the system, ensuring required reviews and approval events are never missed.
5. Support versioning and audit trails
An EDMS can automatically create auditing trails for all your documentation, showing version histories, changes and approvals.
6. Integrate electronic signatures
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)
7. Help you iterate and improve process
With flexible and adaptable controls and SOPs you can adopt and adapt the way you work overtime.
8. Demonstrate compliance for auditors
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.
QMS, eQMS or eDMS, which one do you need?
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. 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.