AUDIT & INSPECTION READINESS

QMS remediation & inspection readiness.

Risk-based correction of QMS gaps and nonconformities, addressing the process that produced the gap — not just the document that revealed it.

What this covers

Risk-based remediation of identified QMS gaps and nonconformities
System-level correction of processes, records, and governance controls
CAPA system strengthening and effectiveness verification
Alignment of QMS documentation with actual operational practice
Evidence mapping and inspection-focused documentation support

When this is typically needed

Following internal audits, regulatory inspections, or certification audits
After receiving regulatory observations or nonconformities
When a QMS exists but lacks consistency, ownership, or effectiveness
Prior to scheduled FDA, Notified Body, or MDSAP inspections

Applicable standards

ISO 13485 FDA QMSR MDSAP

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