MicroLumen, Inc. is a global leader in the manufacture of medical and surgical tubing. Its high-performance medical tubing is used in a wide range of minimally invasive, critical original equipment manufacturer (OEM) applications such as cardiovascular catheters, stent delivery systems, urological retrieval devices, and drug delivery. MicroLumen partners with OEMs worldwide to custom engineer high-performance medical products that meet specific needs.
compliance, up from 45% after 14 days with Propel
CAPA response compliance, up from 60% after six months with Propel
Streamline compliance process management
To successfully support business growth, MicroLumen identified efficiency shortfalls within its business processes. Manual, paper-based record keeping for quality operations became extremely difficult to sustain as the company expanded its customer base to over 1,000 OEMs worldwide. In order to support current and future business initiatives, MicroLumen needed a digital system of record not only to support quality initiatives, but to communicate those changes throughout the organization.
Before Propel, MicroLumen faced inefficiencies in maintaining compliance, particularly with training and CAPA processes. Everything was completed on paper – a cumbersome and error-prone system for processes like document change notices that required employees to manually sign off on updated training. When employees were absent during changes, those signatures were often overlooked due to lack of visibility and monitoring, hence leading to deficiencies in training evidence and compliance.
“Propel delivers clear visibility of our data. With the click of a mouse we have dashboards at our fingertips. These inform the entire company, making it easy to gather information and conduct trend analysis that positively impacts the bottom line.”
Cynthia Soto, VP of Quality Assurance & Regulatory Affairs
Within 14 days of Propel going live, MicroLumen increased training compliance from 45% to 100%. Now, when a document change notice is issued, employees are immediately notified via mobile device, ensuring they are aware of and complete the necessary training on time. Propel also sends automated follow-ups and generates detailed reports for managers, highlighting which employees have yet to complete their training within the allotted time frame.
Propel’s robust tracking and reporting capabilities enhance traceability throughout the product lifecycle, making it easy to monitor changes, identify trends, and execute data-driven business decisions. Propel’s cloud-based solution scales with MicroLumen’s business, allowing it to easily adapt to ever-changing regulatory requirements. Propel’s customized workflows provide clear visibility to corrective and preventive actions (CAPAs), complaints, deviations, and training, ensuring consistency and reducing the risk of non-compliance. MicroLumen’s CAPA response compliance increased from 60% to 98% in just six months with Propel’s streamlined process management and automated reminders. In addition, deviations for products and processes are now consistently completed on a timely basis with approvals from all necessary parties, even when team members are away from the office.
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