AAMI TIR36 : 2007

Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 General
  1.1 Purpose and intent
  1.2 Scope
  1.3 Document organization
2 Regulatory context
  2.1 Context of 21 CFR 820.70(i), Automated processes
  2.2 Context of the Quality System Regulation
      (QSR) - 21 CFR 820
  2.3 Context of 21 CFR 11
  2.4 Context of the General Principles of Software Validation
3 Software validation discussion
  3.1 Definition
  3.2 Confidence-building activities: The tools in the toolbox
  3.3 Critical thinking
4 Software validation and critical thinking
  4.1 Overview
  4.2 In scope?
  4.3 Develop phase
  4.4 Maintain phase
  4.5 Retire phase
5 Documentation
6 Prerequisite processes
Annexes
A - The toolbox
B - Risk management
C - Examples
Example 1: PLC for manufacturing equipment
Example 2: Automated welding system
Example 3: Automated welding process control system
Example 4: C/C++ language compiler
Example 5: Automated Software Test System
Example 6: A simple spreadsheet
Example 7: A (not so) simple spreadsheet
Example 8: Parametric sterilizer
Example 9: Nonconforming material reporting system - Total
            system upgrade
Example 10: Software for scheduling nonconforming
            material report review board meetings
Example 11: Approved vendor list system
Example 12: Calibration management software
Example 13: Automated vision system
Example 14: Pick and place system
D - Definitions
E - Bibliography