EPTAM rolls out Novunex eQMS across its manufacturing network

EPTAM Precision Solutions has implemented Novunex eQMS as an enterprise quality platform across its medical device manufacturing network. The rollout is meant to improve consistency, compliance, and audit readiness for OEM customers as the system expands across multiple sites.

Why it matters: - EPTAM is using a single electronic quality system to standardize quality work across a multi-site medical device manufacturing network. - The move is aimed at improving consistency, traceability, and audit readiness for OEM customers. - The platform is designed to help support new product introduction, validation, and production.

What happened: - EPTAM Precision Solutions announced it has implemented Novunex eQMS as an enterprise quality platform across its manufacturing network. - The platform is now in use and is being expanded across the network. - EPTAM is a Frazier Healthcare Partners portfolio company and precision contract manufacturer serving the medical device industry.

The details: - The system digitizes and standardizes document control, equipment and supplier management, issue investigation, nonconforming material handling, and corrective and preventive action, or CAPA. - For medical device OEM customers, the platform is meant to provide faster access to quality records and better visibility into quality-system performance. - Novunex eQMS supports ISO 13485:2016, FDA 21 CFR Part 820, EU requirements, and electronic records and signatures. - The system includes centralized documentation, configurable workflows, electronic approvals, role-based responsibilities, and traceable data to support inspection readiness. - EPTAM says its quality approach supports repeatable, scalable performance from development through validated production. - EPTAM maintains ISO 13485:2016, ISO 9001:2015, and AS9100D certifications, holds FDA Facility Registration, and operates ISO Class 7 and 8 cleanrooms. - EPTAM was founded in 1981 and is headquartered in Northfield, New Hampshire. - EPTAM makes medical device components, single-use disposables, and finished device assemblies. - EPTAM's capabilities include polymer and precision metal machining, injection molding, liquid silicone rubber molding, and laser cutting and welding. - EPTAM also offers rapid prototyping, process development and validation, cleanroom assembly, and technical program management. - More information is available at EPTAM's website. - EPTAM's LinkedIn page is available at the company's LinkedIn profile. - EPTAM's YouTube channel is available at the company's YouTube channel.

Between the lines: - The rollout signals a broader push to reduce variability in regulated manufacturing as EPTAM scales. - A centralized eQMS can make quality processes easier to manage across sites and may help customers move programs through development and validation with less friction. - The implementation also reinforces EPTAM's stated operating philosophy, “Reliability Requires Rhythm.”

What's next: - EPTAM will continue expanding the platform across its manufacturing network. - The company expects the system to support customer programs as they move from development into validated production. - Novunex said it will continue supporting EPTAM with the platform as compliance and operational demands grow.