AAMI TIR36 : 2007
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
VALIDATION OF SOFTWARE FOR REGULATED PROCESSES
Hardcopy , PDF
10-04-2020
English
01-01-2007
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
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