Quality Systems Audit Services

Quality Systems Compliance Inc. serves the needs of businesses working in the FDA Regulated Industries including Medical Devices, Pharmaceuticals, Tissue, and Food. We specialize in Quality Compliance, Quality Assurance, Quality Systems Audits, and Quality Control.

Quality Systems Compliance Inc. provides auditing services including GAP ASSESSMENTS, INTERNAL AUDITS, SUPPLIER AUDITS, and DUE DILIGENCE AUDITS.

A GAP ASSESSMENT is a PROACTIVE approach that can provide an accurate picture of the management of the current quality management system. This type of quality systems audit can assist in formulating action plans prior to visits from Notified Bodies or Competent Authorities.

INTERNAL AUDITS are a REQUIREMENT for most ISO and Regulatory quality systems. Internal Audits are performed at least annually to internally identify potential compliance gaps. Internal Audits can also be used to assess the effectiveness of process interactions.

SUPPLIER AUDITS are a REQUIREMENT for most ISO based and Regulatory quality systems. Effectively managing the Supply Chain is crucial to ensure compliance in the Global Marketplace. Assessing and monitoring supplier capabilities and performance can help prevent unwanted surprises and regulatory compliance issues.

DUE DILIGENCE AUDITS are a must when considering a merger or acquisition. Before signing the agreement, ensure that the quality system and associated records are compliant with quality and regulatory requirements.

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