An effective electronic (eQMS) can support all types of organizational transitions, whether you're scaling and need a more straightforward compliance process, or you're establishing quality management processes for the first time.
An effective eQMS provides the right balance of structure and flexibility to achieve organizational agility.
However, simply having an eQMS isn’t a guarantee that you’ll be able to evolve into a quality-driven organization. Not every software is an agile QMS and not every eQMS solution will provide the ease-of-use and organization necessary for lean, straightforward processes. If you pick the wrong QMS system software or implement the right solution in the wrong way, you could end up with even more cumbersome quality management processes than you have now.
Organizational agility is a crucial characteristic for highly regulated industries in verticals such as pharma, biomedical devices, and life sciences to respond to fast-changing market conditions, emerging regulatory requirements, and customer needs. An agile QMS can allow you to ensure your processes don't become too bloated and challenging for your team to change. In this post, you'll learn about the value of an agile QMS and how to adopt a software which protects organizational flexibility.
An Agile QMS: 4 Reasons It Solves Your Compliance Process Problems
An agile QMS utilizes digital tools to create organizational flexibility through transparency and simplicity while supporting compliance with ISO, FDA, EU, and other bodies. Agile QMS is not entirely synonymous with the agile software development methodology, but have similarities, by supporting the process of continual closed-loop measurement of quality processes against goals and the ability to pivot to support total (TQM), superior product quality, the elimination of waste, or greater customer satisfaction.
An agile QMS software is likely to have specific characteristics which support organizations adopting a more flexible, quality-driven model of business operations. These include:
- Enable you to document your process and map it to overall business objectives.
- Provide reporting and insights to help you continuously improve your quality processes and systems.
- Equip you with the resources necessary to run compliant processes and systems.
There are multiple reasons your organization can benefit from adopting an agile QMS solution, which ranges from the risks of complex processes to the unexpected costs of bloated software.
1. Complex Processes Heighten Compliance Risks
The agile methodology of software development includes 12 core principles, one of which reads "simplicity...is essential." Agile software developers argue that simplicity prevents wasted work and other risks and that agile teams should continually fight complexity. Complex processes are an eQMS risk at highly regulated organizations, but the risks can carry even more significant consequences than wasted hours of software developer time. Complex eQMS processes can heighten your organization's compliance risks for multiple reasons.
- Complex processes in the eQMS can lead to change control issues and issues updating linked procedures.
- Employees may be resistant to follow quality processes which are perceived as inefficient.
- It is more difficult to audit and improve complex processes.
The agile methodology is a system which is centered around continuous improvement, a concept which is also reflected in the ISO 9001:2015 quality management system. Agile preaches that self-organized teams are the most effective form of team and that teams should "reflect at regular intervals" on how to become more effective. If your quality management system is involved, you're going to use a lot of Quality Assurance resources chasing compliance instead of focusing on quality improvements. Focus on simplicity and agility to eliminate risks of non-compliance in your documentation, employee behavior, and audits.
2. Adoption Is Key
You shouldn't adopt eQMS because you have to. While it can help you achieve ISO certification and meet regulatory requirements, an agile QMS can also help you achieve significant cultural transformation. The right software can help you continuously improve your product quality and create a more efficient business. If you achieve adoption company-wide, you can even unlock significant cultural change and move towards a quality-driven organization.
The agile methodology was a dramatically new approach to software development compared to previous models like the waterfall method of software development. The agile framework created a new emphasis on teamwork, team relationships, and team contributions to make a great product. Software developers were brought into meetings and closer to the users to understand how the product fits into use cases and user stories, and developers were encouraged to contribute ideas to create a high-quality product.
Agile principles matter when it comes to achieving an agile QMS throughout the product design, implementation, and adoption phase of your software initiative. Create an initiative team which represents employees from all sectors of the organization, including leadership, QA, research, training, and lab workers to provide input into the software and design. Turn end-users into product champions and empower users to create excitement throughout the organization and ignite a culture of continuous improvement.
3. Bloated Software Burns Budget
Software bloat, as defined by MangoApps, is the tendency of software systems to have unnecessary features or "just generally use more system resources than necessary" without benefit to end users. In the world of SaaS apps, bloated software occurs when you take a simple system or software with the potential for simplicity and over-engineer it beyond the point of reason. Within the context of eQMS, here are some near-certain signs of software bloat:
- Highly customized system design which compromises data traceability
- Unreliable integrations which result in data quality issues
- Workflow or issues which are labor-intensive
- Costly or time-consuming validation and revalidation requirements
- Poor ease-of-use which results in user confusion
Turning a simple workflow into a complicated workflow can eat software budget through expensive configuration, and require more costs for effective implementation by raising the costs of documentation, validation, and training. If the complicated workflow doesn't make sense to end users, it could result in confusion, resistance, and quality issues. Bloated software can burn through budget very quickly, and compromise your quality goals.
Within the agile methodology, simplicity is vital. This is achieved through the use of "user stories," which put the developers in the shoes of the end user to understand how real people interact with the software to accomplish common goals. User stories for an agile eQMS can include, but aren't limited to:
- As a QA Manager, I want to verify company-wide training progress quickly.
- As a lab worker, I want to input quality data on my mobile device in real-time.
- As a C-level, I want to create FDA-compliant eSignatures from any connected device.
Focus on user stories and simplicity to avoid the costs and risks of bloated software.
4. Quality-Driven vs. Compliance-Focused
Compliance with all applicable FDA and EU regulatory requirements is a steep task for organizations in pharma, life sciences, and medical device industries to unlock. However, understanding the difference between a quality-driven vs. compliance-focused organization is essential. "When you focus too narrowly on compliance, you are driving with blind spots," writes Erwin De beuckelaer. A compliance-focused culture is a culture which is defined by careful control over documents, metrics, and data, without bothering to understand the more significant story behind organizational metrics. Sometimes, data which complies with FDA requirements isn't indicative of actual quality or risk-based thinking.
When your QMS is built around complying with regulatory requirements and careful control within current boundaries, you're also running another risk--a loss of agility. What happens when the FDA, EU, or other regulatory agencies introduce new regulatory requirements which demand a change in processes? If your organization has been focused on meeting requirements instead of understanding how your processes contribute to quality, you could struggle to adapt due to rigid operating procedures.
The Agile methodology was created to reduce the risks that commonly occur on software development projects when requirements change, much like the need for change which organizations in highly regulated industries face. The second principle is to “embrace” changing requirements and adapt to change as a competitive advantage. By creating a quality-driven culture which improves proactively, you can stay ahead of compliance requirements and avoid becoming a rigid organization which ignores opportunities for improvement.
Getting An Agile QMS
An Agile QMS should help your organization quickly achieve compliance by providing support for regulatory requirements where necessary, and help you achieve a quality-driven culture with the flexibility for process iteration. For organizations in the pharma, life sciences, and medical device fields, this will generally involve selecting a right-sized, cloud-based eQMS application which offers the right balance of simplicity and flexibility for your industry and needs. An Agile QMS should offer support for the following use cases:
- Support for FDA 21 CFR, 21 CFR Part 11,ISO 13485:2016 & ISO 14971
- End-to-end traceability between documents and records
- Step-by-step guided workflows for training, documents, , and other requirements
- Automated reminders and linked quality processes
- Built-in template engines and simple document editing features
- Rich process libraries with folders, subfolders, and permissions
- Support for detailed SOPs with multimedia references and guides
- Dynamic procedures and processes to capture data, including form fields
- Closed-loop quality monitoring, including visibility into process non-conformance
Choosing An Agile QMS For The Long-Term
Scalability is a crucial characteristic of an agile QMS, especially for highly regulated startups and scale-ups with aggressive growth goals. Just because an eQMS can offer agile characteristics such as simplicity and ease-of-use in the immediate term doesn't mean it won't become bloated or cumbersome when you add a dozen new users or expand your processes. Consider growth when evaluating solutions, and whether the QMS software will need to be replaced or integrated in the mid term to support your expansion to processes such as CAPA.
Agile QMS selection, implementation, and adoption can be a significant undertaking, and the solution you choose should continue providing value to your organization for the long term. Discuss your growth goals and long-term vision for the system with prospective vendors to understand how software can continue to support your transition to a quality-driven culture.
How does your organization stack up against industry benchmarks for readiness to scale, the risk of adverse findings, and quality best practices? Take a short, self-guided survey to find out! Get your quality score.