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The Auditing Group is comprised of only the best
Auditing Consultants in the GXP regulated industry working under one
standard.
With over 50 years of combined industry experience, The
Auditing Group provides the knowledgeable industry experience and FDA
insight that your company deserves.
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Offering
both on-site and off-site services to meet your specific needs.
experienced, confidential, and client focused.
Audit reports arrive within 20 business days of the audit's
completion. Also offer complete audit program management services
that includes total observation follow-up with the auditee through
to audit closure accompanied by monthly status reports to ensure
all audits are properly closed. |
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Understanding that the most important resource in an
organization is it's personnel. GMP Audits acts as your agent to
assess the current state of the auditee in a positive manner
against agreed contracts/regulations/standards and to assist the
auditee and the client make improvements in a win/win/win manner
for the personnel/auditee/client. |
Specializing in:
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cGMP -
Current Good Manufacturing Practices |
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SOP,
NDA, IND, PMA, 510k & Validation Audits |
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21 CFR
Part 11 - Electronic Systems, 21 CFR Part 11 |
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GLP -
Good Laboratory Practice Auditing |
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GCP -
Good Clinical Practice Auditing & Training |
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Auditor Training - In house training of Auditing Staff |
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Vendor
/ Sponsor Audits - Suppliers and Subcontractors |
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Investigator & Site Monitoring - Clinical |
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Maintenance & Engineering Practice & Compliance |
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