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SMELab Auditing & Consulting

Chicago Metropolitan Area

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Laboratory audit lead presenting process findings

CAPA Development,
Implementation, and Effectiveness Checks

CAPA that closes the loop

We design CAPA programs that are actionable, tracked, and verifiable, ensuring corrective actions are implemented and effective over time.

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Additional Services

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FDA Form 483 responses

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Audit findings and observations

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CAPA development & audit response support

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