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Auditing Services

QRC auditing functions include activities that will determine the quality and operational status of our client systems.  QRC brings to our clients a vast quantity of FDA and industry experience providing insight into the current thinking and interpretations of laws and regulations enforced by governmental regulatory agencies.

At the conclusion of an audit, QRC will conduct a close-out meeting with you, providing a clear, concise written report documenting significant observations.  We will also discuss our interpretation of the observations with you emphasizing the significance of each item with respect to the laws and regulations enforced by the FDA, DEA, and other government regulatory authorities. 

Recommendations will be provided such as training, validation performance, establishment of an internal audit program, etc. that may have a positive impact in the overall compliance status of our clients.

Some Auditing Services include, but are not limited to the following:

  • Internal cGMP Audits

  • Quality Systems Evaluation

  • Compliance Assessments

  • Mock FDA Audits

  • Pre Approval Inspection (PAI)

  • API Q7A Audits

  • Contract Manufacturer Audits

  • Labeling/Packaging Audits

  • Supplier and Surveillance Audits

  • Validation Audits



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