Quality Systems Compliance, LLCLooking for GAP Analysis Auditing in Ohio?

Consider Quality Systems Compliance, LLC and Mark Durivage, specializing in FDA, ISO and Quality Systems auditing, training and consulting for the medical and auto industries, and organizations involved with tissue and food.

We provide GAP Analysis Auditing in Ohio, across the U.S. and internationally.

GAP Analysis Auditing in Ohio
GAP Analysis Auditing in Ohio

Please visit our Home page to begin learning more about Auditing and other services provided by Quality Systems Compliance, LLC. We look forward to helping your organization meet your GAP Analysis goals in a quick, cost-effective manner.

Quality Systems Compliance, LLC provides auditing support including GAP ASSESSMENTS, INTERNAL AUDITS, SUPPLIER AUDITS, DUE DILIGENCE, MOCK FDA INSPECTIONS, and MDSAP AUDITS.

A GAP ASSESSMENT is a PROACTIVE approach which can provide an accurate picture for the management of the current quality management system. This type of 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.