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

Applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, and complaint handling, or to automate any other aspect of the quality system as defined by the Quality System Regulation (21 CFR 820).