Module30 April 20264 min read
Module spotlight: Batch & Lot Tracking
Traceability is the difference between a targeted action and a blanket one. Batch and lot tracking lets you follow product through manufacturing and release, unit by unit.
By MoniDoseQMS Team
When something needs investigating — or recalling — the first question is always: which units are affected? Batch and lot tracking, with manufacturing records and product release, gives you the traceability to answer that precisely instead of acting on everything.
What you can do
- Track product by batch and lot through manufacturing
- Keep manufacturing records tied to each batch
- Control product release with the right approvals
- Trace a unit back through its materials and processes
Why it matters
Production and process controls under ISO 13485 §7.5 and FDA 21 CFR 820.70 depend on traceability. When a problem surfaces, batch-level tracking turns a potential mass recall into a precise, defensible action.