5 Signs You’ve Outgrown Your Quality Management System (QMS)

An early indication that your QMS no longer suffices is when its configurability is limited. Some starter solution providers will tell you they can get a QMS implemented and running in a matter of weeks. These basic systems might offer out-of-the-box processes, which seem adequate at the start. However, as your company grows and operational demands increase, these rigid, unconfigurable systems become a straitjacket, unable to evolve with your business. They may also tie you to certain underlying platforms (e.g., Salesforce) or restrict the addition of new features and functionalities tailored to meet the specific needs of industries like life sciences manufacturing.

Sources of Quality Events

True efficiency necessitates a modern, connected QMS solution like MasterControl’s Quality Excellence, which offers the best of both worlds by offering not just ready-to-use process templates but also extensive configurability options. MasterControl’s QMS solution gives you the flexibility to:

• Use the preconfigured processes as is.
• Make personalized adjustments to the included templates.
• Create something entirely unique to meet your exact needs using the solution’s no-code builders.

This flexibility allows for adaptations to fit your precise organizational needs both today and tomorrow. Plus, MasterControl’s proven implementation best practices and 30-plus years of industry expertise mean you can still get up and running quickly.

Increasing validation burdens are another major sign that your QMS needs an upgrade. With basic QMS software, stepping outside the standard setup usually means you cannot utilize prepackaged validation tools, which inevitably results in time-consuming and costly manual validation processes. And it’s impossible to scale quickly if you’re spending weeks or months on validation activities. A QMS that only offers pre-packaged or limited validation solutions not only delays your scaling efforts but also increases risks of noncompliance.

In contrast to these starter systems, advanced QMS solutions such as MasterControl have developed robust, risk-based validation tools that align with the latest U.S. Food and Drug Administration (FDA) guidelines, enabling validations in a matter of minutes — even for highly customized configurations. In fact, MasterControl is the industry leader in risk-based validation, developing a risk-based approach years before the FDA released an official guidance recommending the approach. MasterControl’s patented validation tools, the Validation Excellence Tool (VxT) and Validation on Demand (VoD), enable users to validate in a matter of hours for their initial implementation and in a matter of minutes for upgrades. MasterControl customers can even easily validate completely customized configurations in minutes, ensuring that the flexibility of unique processes remains a benefit rather than becoming a time-consuming validation burden.

The functionality limitations of your QMS can be glaringly obvious when employees continually use workarounds or when essential features that come standard in more mature QMS solutions, like comprehensive audit trails or integrated document management, are absent. Maybe you’ve seen shortcomings such as these in your organization:

• Inability to review documents within the QMS system, forcing downloads that complicate version control or become lost easily.
• Limited audit trails that don’t completely meet regulatory requirements.
• Lack of reporting on overall employee training compliance.
• Strict out-of-the-box processes that severely limit configurable data tracking.

Constraints like these often force organizations to adopt piecemeal solutions that can lead to data insecurity, regulatory noncompliance, and inefficiencies in process management.

Advanced QMS platforms like MasterControl offer wide-ranging functionalities that address intricate needs specific to industries like life sciences and are designed to grow with companies, ensuring compliance and enhancing efficiency without the need for risky workarounds.

MasterControl has dedicated decades of development efforts to delivering extensive functionality based on customer needs and feedback. Our thorough understanding of the quality landscape means that MasterControl QMS software can solve every scenario — from formal quality events to compliant, optimized change control and everything in between — with full, no-code flexibility. Empowered with this flexibility, it becomes your choice to design your quality processes your way. You can make them as simple or as elaborate as your organization’s needs require and make refinements to those processes as you grow.

Automation — or the lack thereof — can signify an ineffective QMS. Older or basic systems might have disconnected modules that don't communicate well or are paper/software hybrids that require manual intervention to transfer data or process actions. These siloed modules not only limit data sharing, but they also increase the likelihood of more errors occurring and are often reliant on custom application program interfaces (APIs) to deliver even the most basic levels of automation. Such an approach not only defeats the purpose of automation — to improve efficiency — but often requires additional manual processes and workarounds. These inefficiencies increasingly expose quality processes to human error, leading to inconsistencies and potential compliance issues.

Contrast this lack of connectivity with proven QMS software like MasterControl in which a unified platform seamlessly links data flows and automation ensures that processes stay concise and connected. The MasterControl QMS system is built on one shared, interconnected platform that delivers on the promise of truly closed-loop quality. The integrated modules are specifically designed to share data, automate processes, maintain a detailed, auditable record across systems, and deliver real return on investment (ROI) that’s driven by significant time savings and a quantifiable reduction in manual workloads.

Consider an example of situations that quality teams commonly encounter and the ways a robust QMS solution like MasterControl makes them easier to manage: A quality event may be triggered by an event like a customer complaint, a deviation that’s discovered, or an audit finding. Within the MasterControl system, that quality event can be assessed for risk and root cause and, if necessary, a corrective action/preventive action (CAPA) can be launched directly from the initial event. This ensures the processes remain connected for both data integrity and audit purposes. Once the CAPA is resolved, a preventative action may directly launch a document change control action to update an associated standard operating procedure (SOP) with the aim of preventing further quality events. The MasterControl system sends that SOP through the appropriate document change control process so it can be approved to become a new version of record while archiving the previous versions of the SOP. The requisite training for all affected employees can then be automatically launched as part of the document approval, providing the assurance that everyone has the appropriately updated documentation and is unified in their compliance efforts. The integration of these processes helps ensure successful audits and lets employees pivot to more valuable initiatives.

Lastly, innovation, or rather the absence of innovative capabilities, can be a red flag that signals an outdated system. Smaller or less sophisticated QMS software providers might lack the resources to actively invest in new features or improvements, having to choose between investing in marketing the product or in the development of the QMS itself. Ask yourself: Is your QMS provider spending more money garnering attention for their QMS than they are on delivering functionality that’s useful in the real world? These tradeoffs prevent customers who rely on their QMS solutions from leveraging the latest in digital and automation advances, such as artificial intelligence (AI) and machine learning (ML).

MasterControl’s significant investments in innovation have led to the development of exciting new tools like Advanced Quality Event Management, electronic logbooks, and GxPAssist AI. Trailblazing tools like these don’t just optimize quality processes — they also future-proof them, ensuring your QMS solution remains ahead of the curve. In addition to MasterControl’s monthly releases in which new features are added, we’re dedicated to investing in and releasing even more innovative, indus- try-leading solutions and continued product development in the coming years. Plus, MasterControl has complete control over our platform architecture, so we can develop exactly what our customers are asking for and iterate based on regulatory or market changes.

Recognizing these five signs is pivotal for any organization serious about adhering compliance stan- dards and maintaining and enhancing product quality. Upgrading to a more comprehensive, configu- rable, and innovative QMS solution like MasterControl not only resolves these common limitations but also transforms quality management into a strategic asset, driving efficiency, reducing risk, and sup- porting successful scale and growth. Now is the time to assess your current QMS system and consid- er whether it’s helping you meet your quality goals or holding you back.