Our Services
What we do
SME Lab Auditing & Consulting provides comprehensive laboratory auditing and regulatory compliance services designed to help laboratories meet FDA and ISO/IEC 17025 expectations with confidence.
Our approach is practical, risk-based, and aligned with real laboratory operations.
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FDA Inspection & ISO/IEC 17025 Audit Preparation
We prepare laboratories for FDA inspections and ISO/IEC 17025 audits by evaluating current systems, identifying gaps, and strengthening compliance readiness. Our support helps laboratories respond confidently before, during, and after inspections.
Our audits are thorough, objective, and focused on improving compliance, operational effectiveness, and inspection outcomes.
Regulatory Gap Assessments and Readiness Evaluations
We assess laboratory operations, documentation, and quality systems against applicable regulatory and accreditation requirements to identify compliance gaps and prioritize corrective actions.
CAPA Development & Audit Response Support
We assist with:
FDA Form 483 responses
Clear, defensible responses aligned with regulators.
Audit findings and observations
Prioritized remediation plans with measurable outcomes.
CAPA development, implementation, and effectiveness checks
CAPA programs that close the loop and prevent recurrence.
Our goal is not just to close findings, but to prevent recurrence.
Method Validation & Quality Systems
We support method validation activities and the development, implementation, and improvement of laboratory Quality Management Systems that meet regulatory and accreditation standards.