Six stages, from data source mapping to ongoing trend review.
The same disciplined process whether it's a single production line or a full manufacturing network across multiple sites.
Data Source Mapping
We identify what actually exists — LIMS, MES, electronic batch record systems, historian data — and confirm what's already validated versus what would need qualification before use.
Historical Batch Data Ingestion & Cleanup
Historical batch and deviation data gets consolidated and cleaned for analysis, respecting existing validation boundaries rather than exporting into an ungoverned working copy.
Baseline Process Capability Analysis
We establish current process capability against defined specifications before proposing any control limits, so the baseline reflects where the process actually stands today.
Deviation & OOS Pattern Analysis
Historical deviations and OOS results get analyzed for patterns by process step, equipment, shift, and time — surfacing correlations that isolated investigations wouldn't reveal.
CPV Dashboard Deployment
Control charts and trend dashboards go live against agreed CPP and CQA limits, with flagging thresholds tuned to your process rather than a generic default.
Ongoing Trend Review & Regulatory Reporting Support
A standing review cadence keeps the dashboard connected to an actual decision-maker, and reporting formats are built to drop directly into your existing quality documentation.
Almost never the statistics. Almost always the data source mapping.
Running a control chart against clean, well-structured data takes very little time. Establishing which of three overlapping systems is the authoritative source for a given parameter, and confirming its validation status, is where real engagements spend the bulk of their early hours. We treat that groundwork as the deliverable that makes everything after it trustworthy.