Introduction:
LumiraDx, a leading medical device manufacturer, required a solution to the inefficient and time consuming calibration process.
LumiraDx sought to align their calibration procedures through the implementation of a Computerised Maintenance Management System (CMMS). This would deliver the following benefits:
- Optimised Calibration Practices: The existing manual calibration tracking and scheduling processes were time-consuming and prone to errors.
- Alignment with Regulatory Compliance: LumiraDx needed to ensure that its calibration practices followed best practice guidelines, ensuring continued regulatory and legal compliance.
- Enhanced Data Management: Managing calibration documentation, records, and reports was decentralised and inefficient.
Solution:
PEMAC, a trusted asset management software provider, worked closely with LumiraDx to address these challenges and provide tailored solutions:
Benefits:
IMPROVED EFFICIENCY
Automated calibration tracking and streamlined workflows improved process efficiency, reducing time and effort. The PEMAC solution also allowed LumiraDx employees to focus on higher-value tasks, leading to increased productivity.
COMPLIANCE ASSURANCE
PEMAC’s integrated document management system ensured easy access to calibration records and related documentation. It also promoted compliance with industry regulations, mitigating regulatory risks.
RISK MITIGATION
The optimised calibration process reduced the risk of errors, ensuring accurate measurements and data integrity.
AUDIT READINESS
LumiraDx was well-prepared for regulatory audits, with organised and easily accessible calibration data. Also, effortless retrieval of calibration records and reports facilitated seamless audits.
Summary:
The implementation of PEMAC ASSETS CMMS software and the subsequent collaboration between LumiraDx and the PEMAC Services division resulted in the successful optimisation of calibration processes, ensuring compliance, accuracy, and efficiency. The integration of automated calibration tracking, CMMS calibration module customisation, document management, and streamlined workflows empowered LumiraDx to overcome challenges and achieve audit readiness. With these improvements, LumiraDx continues to maintain its reputation as a highly reliable medical device manufacturer in compliance with industry standards.
“We reviewed several options for our Asset Management, but PEMAC ASSETS was the clear winner. It is a paperless system with everything in one place and a range of optional modules available, such as Contractor Management.” Billy McKee, Engineering Manager, LumiraDx
“We’ve been working with the PEMAC Services team since we implemented PEMAC across our multi-site Scottish operations in 2021. They have been a joy to work with, ensuring we have robust maintenance procedures and processes in place, and making the PEMAC ASSETS CMMS software a cornerstone for LumiraDx in achieving regulatory compliance.” Liam Mills, Engineering Director, LumiraDx
