Solution
For quality and manufacturing teams running deviation investigations: one structured case file correlating batch records, equipment logs, and SOPs, with CAPAs tracked to closure.
The problem
Batch records in one system, equipment logs in another, the governing SOP three revisions deep in a repository. Assembling the facts is most of the investigation.
While investigators gather evidence, the clock on batch release, remediation, and regulatory response keeps running — and quarantined product keeps sitting.
An investigation whose evidence lives in email threads and memory fails the one test that matters: showing an auditor what happened and how you know.
The product, not a promise
How it works
Ingest batch records, equipment logs, operator notes, and the SOPs in force around the deviation.
Line up timestamps, procedure steps, and readings across sources into one case file.
Surface candidate root causes with the supporting record attached to each.
Assign corrective and preventive actions and track them to closure.
Approve the conclusion and file the audit-ready investigation history.
Who it's for
Investigator
Quality director
QA & audit response
Every deviation starts an investigation, and every investigation starts with a scavenger hunt: batch records in one system, equipment logs in another, the governing SOP three revisions deep in a document repository. The facts exist. Assembling them is the work — and while investigators assemble, the clock on release, remediation, and regulatory response keeps running.
The Process Investigation Workbench constructs the investigation file for you. It ingests the records around a deviation — batch records, equipment and environmental logs, operator notes, the SOPs in force at the time — and correlates them into a single, structured case. Timestamps in the equipment log line up against entries in the batch record. Procedure steps line up against what the SOP actually requires. Deviations, contributing factors, and candidate root causes surface with the supporting record attached to each.
Investigators then work the case in a structured cycle: confirm or reject candidate causes, document the rationale, assign corrective and preventive actions, and track them to closure. Every finding links to the document, data point, or record that supports it, so the conclusion is checkable by anyone who reads it — and the case file updates as new records arrive, without losing the status of items already reviewed.
Process investigations exist because a regulator, an auditor, or your own quality system will one day ask what happened and how you know. The workbench maintains an audit-ready history of every investigation cycle: what was found, who reviewed it, what was decided, and which records supported the decision. Root-cause conclusions are proposed by the system and approved by people — that is the platform’s standing rule. When the question comes, the answer is already a file.
Objections, answered
Each candidate arrives with the supporting record attached — the log entry, batch record line, or SOP step behind it. Investigators confirm or reject with documented rationale; the system proposes, people conclude. Nothing free-floating enters the file.
The cycle — capture, correlate, identify, act, close — maps to your deviation SOP, your severity classes, and your CAPA workflow. Conformance is checked against the SOP revision in force at the time of the deviation, not today's.
The full history of the investigation: records ingested, findings raised, causes confirmed or rejected with rationale, CAPAs assigned and closed, and the named approver on the conclusion. The answer to what happened is a file, ready before the question.
The workbench starts from records you already have — batch records, equipment logs, SOPs — with no system replacement required. Run it first on a recent closed deviation to see the case file it builds; it deploys in private cloud or on-prem.
Watch the workbench assemble the case file live — timeline, conformance checks, candidate causes — from the records you already have.
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