Auditing and Validation Services for FDA Regulated Industry




 P FDA.COM Information PortalAud

Good Auditing Practice
Good Auditing Practice Linkedin Group

Audit Contracts - Jobs
Audit Contracts and Jobs Linkedin Group



1 Day Electronic System Validation Boot Camp

All Boot Camps Includes:

  • Travel
  • Hotels
  • Expenses
  • Up to 20 Binders, Handbooks and Certificates*
* Additional copies available for $50.00 each
Day 1 Topics
  • Introduction to Computerized System Validation
  • Definitions, System Types and Classifications
  • 21 CFR Part 11 Electronic Records; Electronic Signatures – Predicate Rule
  • Risk Analysis - Determine Which Systems Need to be Validated
  • Software / System Development Life Cycle (SDLC)
  • Compiling the Validation Master Plan (VMP)
  • Project Plan (PP) Development
  • User Requirement Specifications (URS)
  • Functional Requirement Specifications (FRS)
  • Design Specifications / Design Qualifications (DQ)
  • Installation Qualifications (IQ)
  • Operational Qualifications (OQ)
  • Performance Qualifications (PQ)
  • Auditing GxP Computer Systems



2002 - 2013 The Auditing Group, Inc., a New Jersey Corporation. All rights reserved
Home  |  Contact Us  |  Site Map

Auditing - Full Service Auditing Services