Module5 May 20264 min read
Module spotlight: Field Safety Notices & Recall Management
When a product on the market needs action, speed and traceability are everything. Field safety notices and recall management give you a controlled way to act and to prove you acted.
By MoniDoseQMS Team
No manufacturer wants to issue a field action — but being ready to do one well is a mark of a serious quality system. Field safety notices and recall management give you a controlled, traceable process for the moments when a product already in use needs attention.
What you can do
- Issue and track field safety notices
- Manage recalls through a controlled workflow
- Connect actions to the affected products, batches, and records
- Keep a complete, traceable record of the response
Why it matters
EU MDR vigilance (Articles 87-92) sets clear expectations for how manufacturers respond to safety issues. A controlled process — linked to batch records, complaints, and CAPA — means you can act quickly and demonstrate exactly what was done, for whom, and when.