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Key Takeaways:

  • The tangible benefits of implementing a future-ready, cloud-based EQMS are well known. These include increased productivity, reduced Cost of Quality (CoQ), automation of regulatory reporting, digital transformation of key quality processes including documentation, audits, inspections, CAPA, Training, risk management, supplier quality, etc.
  • There is no doubt that enterprises need to embrace a next-generation EQMS that uses AI and data analytics to drive Continuous Improvement (CI) of the quality workflow
  • But beyond that, we believe the role of an EQMS is to enable accelerated product innovation and increased customer trust. The real value of automation is often intangible.

ITEK is a Costa Rica-based manufacturing company that is a trusted partner for medical device and life sciences companies from around the world. The company offers a wide range of services including manual and automated manufacturing, logistics, and distribution management. From day one, pursuing operational excellence and embracing digital transformation has been a key focus of the company. To make this a reality, the company implemented ComplianceQuest’s EQMS solution to automate quality processes across the manufacturing lifecycle.

Implementing a next-generation EQMS had a direct impact on operations. Specifically, it helped deliver the following tangible benefits:

  • Automation of compliance and regulatory processes: With ComplianceQuest, the quality team at ITEK was able to automate all processes related to ISO 13485 compliance.
  • Increased transparency and accountability: The entire quality management workflow was data-driven and seamless. There was transparency in the flow of information across all stakeholders and it was easy to spot and fix any bottlenecks. Dashboards and reports made it really easy to look up data and spot trends.
  • Leverage best practices: The company was also able to take advantage of ComplianceQuest’s experience and expertise in serving several companies in the life sciences sector. ITEK was able to take an out-of-the-box workflow and customize it only wherever needed.
  • Automate various quality processes: The company implemented several solutions offered by ComplianceQuest including audit, equipment management, document control, change, CAPA, nonconformance, and training management.

The impact of implementing ComplianceQuest was clear; It enhanced productivity; reduced CoQ; and increased Overall Operational Effectiveness (OOE).

But, that was not all; In fact, it was only the beginning of something much bigger.

The Intangible benefits of a next-generation EQMS like ComplianceQuest

When customers visited the ITEK facility, it was easy for plant heads and customer success professionals to pull up the EQMS and access any data they needed. Customers would typically ask for the status of training for specific staff members or the maintenance status of equipment being used. When plant heads could pull up data on a digital platform — anytime, anywhere — it helped them earn their customers’ trust. Dashboards and reports were only a click away. Customers appreciated the deep focus on pursuing a data-driven process for quality management. It gave them piece of mind that their manufacturing partners we extremely serious about quality and compliance.

Implementing an EQMS also resulted in ensuring that team members across the company were highly engaged. Notifications would pop up in the system when they had to take any action. This could be part of a CAPA, inspection, or audit process. It could also be part of a change management effort. Overall, the EQMS certainly enhanced the collaboration between various departments and team members.

This also meant that quality-related decisions and discussions would revolve around data.
Does this equipment need maintenance? Why don’t we pull up the equipment dashboard and look up what the predictive analytics model is suggesting? It became easier for quality leaders to embrace data, analytics, and AI to enable the decision-making process.

The overall point is — driving efficiencies into the quality management process is not only about technology. It is also about people and strategy. It is about highly engaged teams. It is about making decisions based on the best available information.

“It’s a great intangible ROI that gives our customers peace of mind on the suitability and compliance of our quality management systems”, says ITEK’s CEO and Founder

Read ITEK’s Case Study

Can the EQMS enable such a cultural shift where quality becomes an organization-wide effort? Can it act as a catalyst in driving CI across the organization not only through automation but also through a shift in the mindset of your people? These are the larger questions one needs to answer before choosing an EQMS.

For more information on ComplianceQuest’s quality management solution, visit: http://www.compliancequest.com/quality-management-system-qms/

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