AAMI TIR36 2007
$162.84
AAMI TIR36:2007 – Validation of software for regulated processes
| Published By | Publication Date | Number of Pages |
| AAMI | 2007 | 111 |
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). In addition, it applies to software used to create, modify, and maintain electronic records and to manage electronic signatures that are subject to the validation requirements (21 CFR 11). This TIR can also be broadly applied wherever software automates processes regulated by the FDA. This TIR applies to software used in the production of a device and to software used in implementation of the device manufacturer’s quality system. It does not apply to software used as a component, part, or accessory of a medical device or software that is itself a medical device.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR36:2007, Validation of software for regulated processes |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 8 | Committee representation |
| 10 | Foreword |
| 12 | Introduction |
| 13 | 1 General 1.1 Purpose and intent 1.2 Scope |
| 14 | 1.3 Document organization 2 Regulatory context 2.1 Context of 21 CFR 820.70(i), Automated processes |
| 15 | 2.1.1 Explanation 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 |
| 16 | 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 |
| 17 | 3.3 Critical thinking 4 Software validation and critical thinking 4.1 Overview |
| 21 | 4.2 In scope? |
| 22 | 4.2.1 Processes and software extraneous to medical device regulations 4.3 Develop phase 4.3.1 Define |
| 23 | 4.3.1.1 Process requirements |
| 24 | 4.3.1.2 Analysis of process failure risk 4.3.1.3 Validation planning |
| 25 | 4.3.1.4 Software intended use 4.3.1.4.1 Software purpose and intent |
| 28 | 4.3.1.4.2 Software use requirements 4.3.1.4.3 Software requirements 4.3.2 Implement, test, and deploy |
| 29 | 4.3.2.1 Analysis of software failure risks |
| 30 | 4.3.2.2 Validation planning 4.3.2.3 Software implementation (design, develop, build, and test) 4.3.2.4 Validation report 4.3.2.5 Software release |
| 31 | 4.4 Maintain phase 4.4.1 Planning for maintenance 4.4.2 Types of maintenance within the maintain phase |
| 32 | 4.4.3 Process changes: Change to risk control measures 4.4.4 Emergency change 4.4.5 Maintaining for intended use 4.5 Retire phase |
| 33 | 5 Documentation 6 Prerequisite processes |
| 35 | Annex A The toolbox |
| 36 | 1) Develop phase: Define |
| 40 | 2) Develop phase: Implement |
| 43 | 3) Develop phase: Test |
| 47 | 4) Develop phase: Deploy |
| 48 | 5) Maintain phase |
| 50 | Annex B Risk management |
| 58 | Annex C Examples |
| 59 | Example 1: PLC for manufacturing equipment |
| 62 | Example 2: Automated welding system |
| 64 | Example 3: Automated welding process control system |
| 70 | Example 4: C/C++ language compiler |
| 74 | Example 5: Automated software test system |
| 78 | Example 6: A simple spreadsheet |
| 81 | Example 7: A (not so) simple spreadsheet |
| 85 | Example 8: Parametric sterilizer |
| 89 | Example 9: Nonconforming material reporting system—Total system upgrade |
| 93 | Example 10: Software for scheduling Non-Conforming Material Report (NCMR)review board meetings |
| 95 | Example 11: Approved vendor list system |
| 99 | Example 12: Calibration management software |
| 103 | Example 13: Automated vision system |
| 105 | Example 14: Pick and place system |
| 108 | Annex D Definitions |
| 111 | Annex E Bibliography |
