|
GMP Aud |
|
About Us |
 |
|
I would like to thank you for considering The
Auditing Group, Inc. for your Auditing, Training or
Consulting requirements.
TAG first incorporated in 2002, as a GMP Auditing
firm for the Bio-pharmaceutical and regulated
industry world-wide.
The Auditing Group, Inc. and Validations.com work
extensively with the US FDA, and we feel confident
that our experienced, highly talented validation
team can ensure your validation success! |
|
Providing on-site independent pro-active audit of your
current clinical process and procedures providing
comprehensive detailed reports identifying deficiencies,
anomalies, and compliance failures as outlined in the US
Title 21 Code of Federal Regulations (CFRs). Responses
include corrective action measures in easy to understand and
implemented formats! Gauge your practices, process and
procedures!
The Auditing Group, Inc. has the perspective, objectivity,
experience, expertise and services to help ensure your
Company’s compliance success. |
|
|
|
|
 |
|
 |
GMP, GCP, GLP, QS and Part 11 / Systems Audit
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 Services
Gantt and Timeline Development
Template Implementation
SOP Development
Development
Part 11 Initiatives
|
|
|
  
  |
