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Cutting Costs and Enhancing Quality: The Business Case for eQMS


Life science professional using eQMS software on their laptop.

If you are using a paper-based quality management system, I have a couple of questions:

  1. Does it seem too much to handle and operate?
  2. Are you constantly finding errors and/or correcting documentation?

If so, you may be interested in the adoption of an electronic quality management system (eQMS). These systems can be a significant positive change for companies wanting to improve their efficiency and quality. In this blog post, I’ll present some of the benefits of switching to an eQMS.

Understanding the Role of an Electronic QMS

An electronic QMS is a platform that automates all aspects of a quality management system. Instead of paper, you have a digital software platform that offers the ability to process, monitor, and manage quality records across an organization. A properly configured eQMS can offer companies better compliance, improved record keeping, and more competitive positioning in their marketplace.

Cost Reduction Benefits of eQMS

I have heard it many times, “An electronic QMS system is not cheap!” Yes, they can be expensive to implement on the front end. However, reduction in operational costs is one of the primary advantages of adopting an eQMS. In the traditional paper-based systems, routing documents for signatures can be laborious. Additionally, manual systems require significant amounts of physical storage (often off-site), continual maintenance of records, and the labor and timeliness involved in updating and retrieving documents can be an issue during audits. An electronic QMS, however, eliminates these needs, thereby reducing overhead costs associated with paper, printing, and storage facilities.

One of the most important benefits of an eQMS is related to audits. An electronic QMS allows for quicker document retrieval, which allows for faster, smoother, and more productive audits. There is also a reduction of potential errors during audits. These improvements can help companies avoid costs associated with additional work in corrective actions or even fines associated with noncompliance.

Enhancing Product Quality and Customer Satisfaction

An electronic QMS can also provide enhanced product quality and increased customer satisfaction. Most eQMS software solutions provide real-time data tracking and analysis which enable companies to identify quality issues quickly. This proactive approach allows companies to address quality issues and ensure better product quality and consistency. This level of consistency is key to meeting customer expectations and improving customer satisfaction.

Additionally, an eQMS allows for better resource management. By providing detailed insights into production processes and quality control measures, companies can optimize the use of their resources. This means that there is less waste of materials and every part of the process is as efficient as possible.

Streamlining Decision-Making Processes

Decision-making can be faster and more effective with an electronic QMS. Using the data analytics from the eQMS, managers can have essential, up-to-date information available to provide clear and concise decisions and do so quickly. Another factor that assists in the streamlining of decisions is the collaborative nature of these systems. Again, they must be properly configured to do so, but providing cross-departmental access allows for the data to be seen by all and assists with collaboration on trends and strategies.

Preparing for the Future – Adaptable and Scalable

It is essential that your company prepares for the future. By investing in an electronic quality management system, you not only address current needs, but you empower your company to handle the future. As regulatory requirements consistently change, becoming adaptable and scalable with your QMS is almost required. An eQMS can be quickly updated to meet new regulations, and its scalability allows it to accommodate growth without significant additional investments.

Conclusion

Think about it! Why are other companies using an eQMS system? From small start-up companies to large Fortune 500 companies, quality leadership understands the value of streamlined operations, accurate data for better decision making, improved compliance, improved product quality, and better customer satisfaction. All of these elements reduce overall costs.

Our world is becoming more digital and connected. In order to compete and be compliant, we must continue to improve and embrace technology. While the transition from a paper-based QMS to an electronic QMS may appear daunting, it is a critical step to positioning your company for the future.

The key is to select the right eQMS and the right implementation partner. There are great consultants in your industry that can provide significant insight as to what you may need. These consultants will assess your processes, help identify the best solutions, and guide you through a successful transition.

Prepare for the future by investing in an electronic quality management system today.

Epilogue

This blog post should provide you with an understanding of potential impacts that an eQMS would have on your organization. As an example, I am consulting with a large company that never made the transition to an eQMS. This company has multitudes of issues as a direct result. Compliance with the regulations is the No. 1 issue, with incomplete records being second. An electronic QMS would have enabled them to avoid regulatory actions. I am not saying that an eQMS would have solved 100% of their problems, but it would have enabled them to quickly see where they are deficient and provide data that would empower them to address some of their regulatory challenges.

David Davis is the president of DGD Enterprises/DGD Solutions, where he leverages over three decades of expertise in quality and operations across various sectors, including medical devices, pharmaceuticals, automotive, and consumer goods. A meticulous leader, David excels in enhancing operational efficiency and compliance with quality management systems and regulatory standards such as ISO 9001, ISO 13485, and FDA 21 CFR Parts 210, 211, and 820. His extensive experience includes leading significant corrective action/preventive action (CAPA) projects, optimizing equipment qualification and process validation for Fortune 100 companies, and creating compliant operational procedures for start-up medical device companies. David has a proven track record in achieving substantial cost savings through strategic sourcing and implementing ERP solutions, notably SAP. He holds a B.S. in organizational management from Tusculum College and resides in Knoxville, Tennessee, where he continues to drive operational excellence and regulatory compliance for manufacturing companies.

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