The challenge
High-risk changes to batch data — status, expiry date, characteristics — are usually found when someone happens to look, often after the batch has moved on.
What you get
- Real-time detection instead of manual monitoring
- Quality, Production and Supply Chain notified automatically
- Faster investigations, with old and new values on record
- Audit-ready traceability, supporting Annex 11 and Annex 16 principles
How it works
From detect to record
01
Detect
Identify critical batch and characteristic changes in real time
02
Assess
Evaluate context, impact and compliance relevance
03
Notify
Alert the owning Quality, Production and Supply Chain teams
04
Record
Keep a complete record with old and new values
Example
A potency result drops from 98.5 % to 95.2 % during release testing. The monitor flags it as critical, notifies Quality and Supply Chain, and the batch is put on hold before distribution.
In the product
Request a Batch Compliance Monitor demo.
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