The LGC Clinical Diagnostics (LGC CDx) Quality Assurance team has had a productive quarter, with the accomplishment of some much anticipated goals and plenty to look forward to in FY23.
In March, the Milford, MA facility reached a major milestone in the journey to EU In Vitro Diagnostic Regulation (IVDR) certification. The Quality and Regulatory team hosted BSI for a three-day IVDR certification audit. BSI’s goal was to assess the Quality System changes made by the QA team for compliance with the regulation. It was a lot of work to get there, but the team succeeded with zero non-conformances and we have been recommended for IVDR certification. More work remains to certify the products, but one big piece is completed.
Thanks to all who contributed to these successes.
In addition to these key accomplishments, QA held the first all-US Quality Management Review and hosted five customer/regulatory audits with no non-conformances issued. The first AccuPlex™ SARS-CoV-2 Control was licensed in Canada, expanding our customer base.
The Quality group in Traverse City (API) continues to work with LGC CDx staff to move procedural documents and training records to EtQ. Requirements and approval groups are being set up following the patterns set by the Maryland, Massachusetts, and Maine sites. Documents will be loaded to the development site in May, going live in June.
The group is excited to have access to this software to streamline their current manual paper processes. While the accreditation in Traverse City is for ISO/IEC 17043 rather than ISO 13485, the LGC CDx processes for document control and training are very similar to those used in Traverse City, and it has been easy to speak the same “language” with the LGC CDx staff. The integration of API/LGCPT into the software will become a model for other CDx sites to join EtQ.
Finally, LGC CDx QA team extends a warm welcome to Wais Osmani, our new Manager, Quality Assurance, based in Milford.
A new Quality Manager at the Oxford site will come onboard in May.