The Auditing Group, Inc. (TAG) has extensive experience within the FDA regulated industries working under the various standards (cGMP, cGCP, cGLP, Systems) with one goal, to provide reliable Auditing, Remediation, Validation, Consulting, Training, and Quality Assurance services that efficiently provide the assistance needed to help our clients succeed.

Let TAG become your Quality Partner.

Drug - Medical Device - Biologics - Laboratory - Part 11 - Validation - Food - Nutraceutical

Not sure if your company can pass a GMP, GLP, GCP, Quality Systems, - Part 11 & QSR Part 820 audit? 
Get an independent assessment of your quality and regulatory readiness today! 

Turn Key 3-day On-Site GMP/API, Mock FDA or Systems Audits

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GMP, GCP, GLP, QS and Part 11 / Systems Audits

21 CFR Part(s) 11, 210/211, 820, ICH Q7

Food and Supplement GMP Audits

Mock FDA - EMEA Audits

Pre-Site Inspections - 'For-Cause'

Quality Assurance Audits

Quality System Audits - Part 820

SOPs, Quality Assurance and Standards Audits

GMP - Good Manufacturing Practice Audit

GCP - Clinical Audits - Regulatory Audits

Equipment Validation Documentation Audit

Software / Systems Validation Audits

Part 11 / Annex 11 Compliance

Vendor & Supplier Audits -

CMOs, Laboratories, API Manufacturers

CROs, Investigators, Monitors, and Study Sites

Database Audits, SAS, CMMS, eDC, eCFR, Safety

Project Management and Support Services

Gantt and Timeline Development

Validation Development and Executions

Training Services

Template Implementation

Procedures and Practice Challenges

Standard Operating Procedures Development

Development Part 11 Initiatives

Design / Build Engineering Services

Certified AIA 'As-Built' Drafting Services

Process and Equipment Validation Services

Software and Systems Validation Services

Design / Build Engineering Services