QMSR & FDA Inspection Preparation

We test whether the quality system can produce objective evidence when an FDA investigator follows a real transaction through the organization — not merely whether the required SOPs exist.

Assess FDA Inspection Readiness

What This Service Is

FDA inspection readiness is demonstrated through implementation and objective evidence. Procedures, records, decisions and actions must connect logically when the investigator follows an actual complaint, CAPA, design change, supplier issue or process validation through the system.

When It Is Needed

Before an anticipated FDA inspection

When transitioning an existing QMS to current QMSR expectations

Before a new US manufacturing site becomes operational

Following significant manufacturing, supplier or organizational changes

When internal audits identify recurring quality-system weaknesses

When the organization wants to test readiness before FDA scrutiny

How We Assess Inspection Readiness

The Evidence Chain

Requirement → Procedure → Record → Objective Evidence → Implementation → Effectiveness

For example, a complaint may be traced into investigation, risk evaluation, reportability assessment, CAPA, effectiveness checks and management oversight. A design change may be traced into risk, verification, validation, approval, implementation and documentation.

Areas We Can Challenge

Design and development controls

Risk management (ISO 14971)

CAPA (Corrective and Preventive Action)

Complaints and vigilance interfaces (MDR 21 CFR 803)

Supplier controls and purchasing data

Production and process controls

Process validation (IQ/OQ/PQ)

Training and competence records

Document and record controls

Internal audits & audit schedules

Management review effectiveness

Nonconformity and escalation pathways

Mock inspection and remediation planning

Our Difference

Testing Evidence, Not Just SOP Titles

We do not prepare firms by checking SOP titles. We test whether the system can withstand an investigator following evidence from requirement to implementation and effectiveness.

QMSR Transition Highlights

Incorporates ISO 13485:2016 by reference
Aligns FDA terminology with international QMS
Rigorous focus on Risk Management (ISO 14971)

Schedule a Mock Audit

Identify system vulnerabilities before an FDA investigator arrives at your facility.

Assess Inspection Readiness

Prepare Your Facility for FDA Scrutiny with Confidence

Our seasoned lead auditors conduct realistic mock FDA inspections and QMSR gap remediation.

Book a Consultation