Auditing Computer
System Providers
Seminar Agenda
AM 9:00 – noon
v Introduction
– Session Agenda and Goals
– Computer System Validation Overview
– Why Perform Software Vendor Audits?
v Audit Process Overview
v Factors Influencing the Audit Process
v Inspection Categories – Building the Audit Checklist
v Introduction to Activities
– Product & Vendor History
– Audit Report Template
PM 1:00 – 5:00
v Standard Operating Procedures & General
Company Information - Activity 1
v System Development Methodology - Activity 2
– Life Cycle Deliverables & Approaches
– Industry Standards
– Design Documentation
v Testing and Verification & Validation Activities -
Activity 3
– Test Phases & Cost of Errors
– Deliverables Supporting Test Activities
– Test Documentation
v Software Change, Version, & Distribution Controls
v Security & Customer Support - Activity 4
v Audit Conclusions, Corrective Action, & Follow-up
v Wrap-up
