Most of the release time is not regulated time.
Batch release and deviation management mined across ERP, LIMS and QMS – compliance intact, cycle time down.
Regulated steps are a small share of the elapsed time. The rest is waiting.
Regulated
Testing2.1 days
Review1.4 days
Unmanaged
Result transfer2.8 days between systems
Signature chase3.2 days by email
Deviation re-open4.6 days
Compliance is not the reason the process is slow. Unmanaged waiting is.
Movement on one release process
-23%
Deviation cycle time to closure.
-5
Days of median batch release lead time.
-41%
Deviations re-opened for missing evidence.
Audit evidence and cycle time can improve together.
Deviations get re-opened because the first investigation lacked the record. Results wait for transfer between LIMS, QMS and the ERP. Reviews are chased outside any system of record, which is both slow and hard to evidence.
Mining the trail fixes both problems with the same change: the evidence is complete because the process is instrumented.
Compliant processes that still move.
Which release process would you like to see clearly?
ERP, LIMS and QMS, read-only.