CPVIn production
Continued process verification
Catch the batch that’s about to fail while you can still fix it.
Plant, lab and quality data live in the same system, so continued process verification doesn’t start with exporting spreadsheets.
What it does
Statistics you can defend in an inspection.
Every calculation states which data it used, what it couldn’t evaluate, and whether the link to the batch is recorded or inferred.
Control and capability
- Declaration of critical parameters and attributes
- I-MR charts with all eight Nelson rules
- Notice of rules that couldn’t be evaluated
- Cpk and Ppk with confidence intervals, in signed studies
The batch in context
- Yield, OEE, downtime and rejects for each batch
- Process variable series linked to the batch
- Data coverage and capture channel status
Golden batch and analysis
- Golden batch profile with eligibility criteria
- Per-variable verdict: inside, outside, no data or no band
- Multivariate comparison of batches with and without deviations
- Statistical capability added to the annual product review
Connected
It shares the record with the rest of the suite.
Modules aren’t integrated through exports: they work on the same batch data.
Compliance
Regulations it supports.
Electronic signatures and the audit trail are the same across the suite.
See the compliance matrix- GMP
- Monitoring the validated process throughout its commercial life.
- 21 CFR Part 11
- Signed, immutable studies, profiles and signal closures.
- Nelson rules
- Statistical method for detecting patterns in control charts.
See your process capability with your batches.
We’ll walk you through the module with a case like yours and show how it connects to what you already use.