Process Investigation Automation

When a batch deviates, the clock starts. Product waits in quarantine while MSAT and quality teams reconstruct what happened from batch records, SOPs, deviation logs, and lab data — much of it scanned, none of it in one place. The investigation becomes document archaeology; the root-cause thinking gets whatever time is left.

Genealogy, SOP checks, and data analysis in one pass

The platform ingests the full investigation corpus — executed batch records, the SOPs that governed them, deviation reports, and lab results — regardless of format. From it, the batch genealogy builds automatically: which raw material lots, intermediates, equipment, and process steps fed the batch in question, and which other batches share that lineage. Tracing the blast radius of a suspect lot drops from a week-long exercise to a query.

Executed records are then checked against their governing SOPs, so missed steps, out-of-sequence operations, and undocumented interventions surface as flagged findings rather than things a reviewer might catch on page 214. Manufacturing and lab data correlate across batches, making visible where a parameter drifted and which batches it touched — the raw material of a defensible root cause.

Built for a regulated record

A pharma investigation file has one audience that matters most: the next auditor. Every finding links to the exact page of the batch record, SOP, or lab report that supports it, and every analysis step is logged. Investigators and QA reviewers approve each conclusion — the platform assembles evidence; people close investigations. The result is document-to-decision work at manufacturing speed: faster approvals, shorter quarantines, and an investigation record that reads the way regulators expect because it was built that way from the first page.