Readiness and Remediation

Internal Audit and Gap Analysis and Remediation resulting in "Common Sense Alignment and Harmonization" of  the following to regulatory guidance and industry best practices adapted to your organizational needs.

·    Policies and Procedures  

·     Design Controls

·      Training

·     CAPA's

·      Consent Decrees

·      483 Observations

·      Warning Letters

·      Internal Audit Findings

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