Why our eQMS ran in parallel for 18 months — and what I’d do differently
The article discusses the challenges faced during an 18-month parallel run of an old and new electronic Quality Management System (eQMS). It highlights issues such as duplicated work, missed automations, and a significant reconciliation backlog. The author shares lessons learned and practical fixes that could help others in similar migration situations.
- ▪The migration involved maintaining a Class II product's QMS during a lengthy transition period.
- ▪Challenges included duplicate record entry, CAPA and complaint duplication, and traceability gaps.
- ▪Practical solutions included freezing non-critical changes, defining canonical record owners, and automating reconciliation reports.
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try { if(localStorage) { let currentUser = localStorage.getItem('current_user'); if (currentUser) { currentUser = JSON.parse(currentUser); if (currentUser.id === 3882280) { document.getElementById('article-show-container').classList.add('current-user-is-article-author'); } } } } catch (e) { console.error(e); } James Whitfield Posted on May 19 Why our eQMS ran in parallel for 18 months — and what I’d do differently #qms #medtech #compliance I’ve been responsible for maintaining a Class II product’s QMS during one of the messiest migrations I’ve seen: an 18‑month parallel run where the old eQMS and the new one lived side-by-side. We survived audits and kept product moving, but we paid for every month with duplicated work, missed automations, and an enormous reconciliation backlog.
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