Choosing the right Quality Management System (QMS) software can change the way organizations do business. At times, organizations are quick to put a system into place without careful consideration of their current and future needs in addition to what different systems have to offer.  

Quality Management System (QMS) Software Considerations

As organizations grow and expand their portfolios, it’s important to invest in a sound QMS. Before selecting a QMS, here are three key considerations to evaluate.  

Is the QMS Robust? 

A robust QMS allows for a defined and controlled process to ensure that all components of quality management (e.g., Batch Record Review, Deviations, Corrective and Preventive Actions, Change Controls, etc.) are captured and documented in accordance with industry regulations. You should also consider the life stage of your organization. The needs of a clinical stage company differ from the needs of a commercial organization. One comprehensive system capable of sustaining a robust QMS proves to be the best choice for most organizations. 

Employees benefit from a strong system. When a robust system is implemented, it eliminates the need for employees to search for information by means of contacting other departments or searching in different systems. This increase in traceability and transparency allows for an organization to function more smoothly and efficiently. 

Organizations will often implement individual, specialized systems for specific processes such as document management and training. Problems arise when these systems do not communicate with one another. If separate systems are being utilized to capture data, extracting and analyzing data becomes a tedious and possibly error-prone task. Working within the same system will eliminate ambiguity and can lead to stronger data integrity.  

Is the QMS User-Friendly? 

One aspect that is often overlooked is the user experience. Is your QMS user-friendly? As organizations evolve, it’s important to choose modern and innovative systems that allow for seamless growth. Systems can be robust but also challenging to use. Consider how and where your users will be accessing the system. Will they be at their desks, or will they also need to use the system from a phone or tablet? By emphasizing system functionality and user experience, the system will be easier to adopt and will drive engagement within organizations.  

Can the System Go the Distance?  

Consider the size of your organization and its growth potential. Is your company a start-up and paper-based? Or perhaps it’s a well-established organization with commercialized products and a strong pipeline. In either case, selecting the right QMS can ensure successful implementation now and allow room for the system to expand as the company grows. Scenarios occur where organizations will implement a different system for each function. At some point, though, this model is not sustainable, and organizations start looking for a comprehensive tool. From a financial perspective, this approach is counterintuitive.. Longevity is an important aspect of selecting the right QMS, and you are encouraged to invest in a system that will grow with your organization. 

There is a plethora of Quality Management System (QMS) software solutions available today, and Clarkston Consulting can help you select and implement the system that is right for your organization.