QMSR enforcement is now active. Are you inspection-ready? Check Your Readiness
Regulatory inspections and audits do not only review documentation. They assess whether an organization can demonstrate the current condition of its quality system across procedures, records, risk files, CAPAs, training, and supporting evidence, most of which was already in place long before any preparation activity began.
When an inspection or audit is announced, organizations typically begin a focused preparation effort: reviewing procedures, gathering records, validating evidence, and addressing issues that surface along the way.
However, the condition of the quality system at that point, whether procedures are current, whether CAPAs are properly closed, whether training records are complete, whether risk files reflect the latest assessments, was largely determined before preparation began. Preparation does not change that condition. It surfaces it.
As a result, issues that have existed for some time are often discovered during preparation rather than when they first occurred. By the time they surface, there may be limited time to address them before the inspection begins.
Issues that have existed for months surface only when inspection preparation begins, leaving little time to act.
A CAPA closed without a training update, a risk file not reflecting current design controls, gaps that remain invisible day to day.
Teams spend inspection preparation time remediating longstanding gaps rather than confirming readiness.
Procedures, records, and evidence drift out of alignment gradually, with no signal until an inspection reveals the gap.
Suricat helps Quality and Regulatory teams understand the current state of readiness across the quality system, independent of whether an inspection has been announced.
By evaluating relationships across procedures, records, risk files, CAPAs, training, and supporting evidence on an ongoing basis, Suricat helps organizations see where the connections an inspection would examine may be incomplete or out of date.
The result is a quality system whose readiness can be assessed at any time, well before preparation activities begin, rather than discovered in the course of them.
Evaluates the condition of the quality system on an ongoing basis, independent of whether an inspection has been announced.
Maps connections between procedures, training, CAPAs, and risk files in the exact way an inspection would examine them.
Identifies where procedures, records, or evidence are out of alignment well before preparation activities begin.
Produces a quality system whose current condition can be demonstrated clearly whenever an inspection occurs.
Five outcomes that strengthen how Quality and Regulatory teams understand, maintain, and demonstrate inspection readiness across the quality system.