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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:
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Internal cGMP Audits
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Quality Systems Evaluation
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Compliance Assessments
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Mock FDA Audits
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Pre Approval Inspection (PAI)
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API Q7A Audits
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Contract Manufacturer Audits
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Labeling/Packaging Audits
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Supplier and Surveillance
Audits
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Validation Audits
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