Selecting an Electronic Quality Management System (eQMS) is one of the most important technology decisions a life sciences organization can make. The right system can accelerate compliance, strengthen quality, and scale with your growth. The wrong choice can drain resources and frustrate users. Leaders should approach this decision not as an IT purchase, but as an investment in the company’s resilience.  

Start with Your Strategy Then Align Your Processes 

Start with your business strategy, not the system. The best solution isn’t just a software purchase; it’s a tool that will support your company’s growth, flexibility, and compliance vision. Consider the following questions:   

• How will a new solution support our need to scale our product pipeline, fit with any global expansion plans, or emerging regulatory requirements?   
• Can it evolve as our quality processes and market conditions change?   
• How might this investment preserve what currently gives us a competitive edge? 

You should also determine the scope and coverage of the eQMS. There are many modules available. A popular implementation technique is to roll out the modules in phases to allow you to focus on those areas with the highest risk first.  

You’ll also want to bring in cross-functional voices early, through interviews, workshops, or leadership roundtables, to help identify both improvement opportunities as well as what’s working well. This ensures your next solution doesn’t just replicate processes but improves them. Consider this as your opportunity for process improvements and efficiency gains. 

Focus on What Drives Adoption 

Next, evaluate how the users should interact with the system. Is mobile access desirable, or should usage be limited to controlled access desktop systems? Ensure that the user interfaces are intuitive to minimize training time and increase user acceptance, as user adoption is critical for project success.  

Determine what systems need to be integrated with the eQMS. Ensure the data is consistent across platforms and the data flow between systems is streamlined. Data security and data integrity measures need to be in place, so evaluate how well the solutions meet the known scenarios for the user base.  

Consider how artificial intelligence (AI) can support your users and drive efficiency.  Tools like Dottie AI  from Dot Compliance provide actionable use cases and have the benefit of being on the market for a few years now.  

Cost and vendor considerations are also important. These include such things as total cost of ownership (TOC), return on investment (ROI), vendor capabilities, vendor support, and the deployment model for implementation. 

Choosing More than a System 

When you’re choosing a system, you’re also choosing a partner. A series of meetings should be scheduled with the eQMS vendors under consideration to gather vendor information, learn about their deployment model options and support service plans, demonstrate the systems’ abilities using provided scenarios, and prepare for head-to-head comparison of the systems’ capabilities. These meetings are typically integrated into the request for proposal (RFP) process. 

Making the Right Choice for Your Business 

When selecting an eQMS, key considerations include functionality (e.g., document control, CAPA, compliance), scalability for future growth, cost, integration with existing systems, vendor reputation and support, and user experience for ease of adoption. As each business is different, it’s crucial to conduct a thorough needs assessment, request demos, and ensure the system meets industry-specific regulatory requirements for your organization’s size and sector. 

Feel free to reach out to Clarkston Consulting for more information about any of these suggestions, or areas such as eQMS assessments, implementation support, training support, or program management. We have supported many clients through this process and are ready to help you on your journey as well.