It’s Alive! How your eQMS should evolve as your quality needs grow

Your electronic Quality Management System (eQMS) is more than just a data storage box – it’s a living, breathing entity that should evolve alongside your organization’s needs. As your company grows, regulations change, and your quality processes mature, your quality management tools have to keep pace.

Why your eQMS should never be stagnant

Does your company look the exact same as it did a year or even 3 months ago? Probably not. New hires or departures, shifting business goals, more competition in the market, new products or research findings, updated processes... in the dynamic world of life sciences, it’s unlikely your organization is standing completely still.

And if your company isn’t stagnant, your QMS software shouldn’t be either. Quality management is the backbone of compliance, product quality, and patient safety. It has to evolve with your organization. A stagnant eQMS is a liability, making processes inefficient, increasing the risk of non-compliance, and even jeopardizing the business as a whole.

Here’s why your eQMS should always be evolving:

• Regulatory Changes: Industry regulations are constantly shifting, and staying compliant with the changes is a proactive endeavor. Whether it's new data tracking guidelines, updated labeling regulations, etc., the way you approach quality within your quality management software is guaranteed to change over time.
• Business Growth and Scaling: As your company grows, your quality management needs will become more complex. Whether you’re expanding into new markets, increasing production, or growing your team, your eQMS must be able to scale with your business.
• Process Improvements: Continuous improvement is the name of the game for successful life sciences companies, and your eQMS should reflect this. As you identify more efficient or effective ways to manage quality, your system should update to support them.
• Risk Management: The risks your organization faces today may not be the same as those it faced a few years ago. Supply chain vulnerabilities, cybersecurity threats, or error-prone manual processes will all spark necessary changes to your eQMS activities.
  
  

Signs it's time to update your eQMS processes

It’s easy to get into a groove (or a “rut” for the glass-half-empty folks) with your eQMS and simply do what’s always been done, whether it’s the most efficient method or not. However, there are clear signs that it’s time to evaluate and update your QMS processes:

• New regulations: Any time a new regulation is announced, set your eQMS review process into motion. What needs to be updated to stay compliant? Will approval workflows need to change? Do CAPA management processes need updated? Will new data need to be added to the system? Will different reports need to be pulled?
• Bloated workflows: Just like a house, an eQMS gathers clutter over time as new workflows and stages are added. Are you collecting the same data across multiple stages? Is the data you’re collecting actually needed? Do you have separate stages that can actually be combined into one? If quality processes are slowing down, bloated and redundant workflows could be the culprits.
• Slow approvals: If your team is struggling with slow approvals and missing signatures, it’s a strong indicator that your eQMS isn’t keeping up with your needs. Take a look at which documents have the longest delay and monitor for any trends in the signature steps that are holding approvals up.
• Risky workarounds: Is your team creating workarounds to bypass limitations in your quality management software? Are your processes moving to manual quality management at any point? Time to reevaluate how your eQMS is configured. These kinds of workarounds can lead to errors, data integrity issues, and overall less efficiency.
• Difficulty scaling: Is it getting increasingly difficult to scale your training matrix as your company grows? Your training management procedures may need an overhaul. Make sure you’re taking advantage of the automations, user groupings, and training courses in your eQMS, as well as eQMS integrations like SCORM.
• Audit Findings and Compliance Gaps: If audits consistently reveal gaps in your eQMS, it’s a clear sign that updates are needed. This could include findings related to document control, data integrity, or lack of alignment with current regulatory requirements. Addressing these gaps proactively by updating your processes can prevent future compliance issues.
  
  

Best practices for keeping your eQMS up-to-date

There are three main goals to focus on while updating your eQMS activities: successfully implement the new processes, train your users, and maintain compliance throughout the transition. Here are some best practices for managing eQMS updates:

• Start with a configurable system: Technically, this is a vital step during your vendor evaluation process, but prioritizing a configurable eQMS is the most important part of keeping your quality process up-to-date. A configurable system makes it easier to adjust your workflows after their initial creation without having to run to IT or your vendor's Support team for every change. Unfortunately, some QMS software platforms advertise themselves as configurable when they really mean they’re customizable, so make sure you understand the difference before choosing a system.
• Conduct a thorough gap analysis: You know something needs to be updated in your eQMS process, but what is it? Use a gap analysis to find out. Where are quality activities falling short? Where are the most errors being generated? What’s taking longer than it should? Your eQMS should have reporting or insight capabilities that provide helpful data for pinpointing opportunities for improvement.
• Engage stakeholders early: Involving stakeholders early in the update process is crucial for getting buy-in and ensuring a smooth adoption. Collaborate with IT, Regulatory, Operations, and other departments to learn which eQMS changes could support their own activities and to get aligned on goals and expectations.
• Requalify new features: Are you using new features in your eQMS as part of your process updates? Just like when you first implemented your eQMS, new features must be qualified or validated to ensure that the system continues to function as intended. Take a look at the validation section on page 14 in the eQMS 301 eBook for details on how this works.
• Test Before Full Implementation: The risk adverse know it’s best to plan for nothing to go to plan. Before officially rolling out changes, use a sandbox environment to test new configurations. This allows you to identify and address any issues without causing disruptions or triggering potential compliance risks.
• Think through a training plan: Adopting new workflows or implementing new modules within your eQMS may require retraining for users. Develop a training plan that covers both the technical updates and the reasons behind the changes.
• Monitor post-changes: Remember, “set it and forget it” should never be in a Quality team’s vocabulary. After implementing changes, monitor the system to make sure everything still functions as expected. Encourage users to provide feedback and be prepared to make adjustments if necessary.
• Plan for continuous review: Continuous improvement is made possible by continuous review. Make periodic reviews, internal audits, and metric tracking standard practices so your eQMS is always keeping pace with your quality needs.

Want to learn more about quality management data security, QMS software validation, and quality management metrics? Check out our eQMS 301 eBook: Best practices for eQMS revalidation, data security, and quality ROI.