The Essential Guide to Requirements Management and Traceability
Chapters
- 1. Requirements Management
- Overview
- 1 What is Requirements Management?
- 2 Why do you need Requirements Management?
- 3 Four Fundamentals of Requirements Management
- 4 Adopting an Agile Approach to Requirements Management
- 5 Status Request Changes
- 6 Conquering the 5 Biggest Challenges of Requirements Management
- 7 Three Reasons You Need a Requirements Management Solution
- 2. Writing Requirements
- Overview
- 1 Functional requirements examples and templates
- 2 Identifying and Measuring Requirements Quality
- 3 How to write system requirement specification (SRS) documents
- 4 The Fundamentals of Business Requirements: Examples of Business Requirements and the Importance of Excellence
- 5 Adopting the EARS Notation to Improve Requirements Engineering
- 6 Jama Connect Advisor™
- 7 Frequently Asked Questions about the EARS Notation and Jama Connect Advisor™
- 8 How to Write an Effective Product Requirements Document (PRD)
- 9 Functional vs. Non-Functional Requirements
- 10 What Are Nonfunctional Requirements and How Do They Impact Product Development?
- 11 Characteristics of Effective Software Requirements and Software Requirements Specifications (SRS)
- 12 8 Do’s and Don’ts for Writing Requirements
- 3. Requirements Gathering and Management Processes
- Overview
- 1 Requirements Engineering
- 2 Requirements Analysis
- 3 A Guide to Requirements Elicitation for Product Teams
- 4 Requirements Gathering Techniques for Agile Product Teams
- 5 What is Requirements Gathering?
- 6 Defining and Implementing a Requirements Baseline
- 7 Managing Project Scope — Why It Matters and Best Practices
- 8 How Long Do Requirements Take?
- 4. Requirements Traceability
- Overview
- 1 What is Traceability?
- 2 Tracing Your Way to Success: The Crucial Role of Traceability in Modern Product and Systems Development
- 3 Change Impact Analysis (CIA): A Short Guide for Effective Implementation
- 4 What is Requirements Traceability and Why Does It Matter for Product Teams?
- 5 Key Traceability Challenges and Tips for Ensuring Accountability and Efficiency
- 6 Unraveling the Digital Thread: Enhancing Connectivity and Efficiency
- 7 The Role of a Data Thread in Product and Software Development
- 8 How to Create and Use a Requirements Traceability Matrix
- 9 Traceability Matrix 101: Why It’s Not the Ultimate Solution for Managing Requirements
- 10 Live Traceability vs. After-the-Fact Traceability
- 11 How to Overcome Organizational Barriers to Live Requirements Traceability
- 12 Requirements Traceability, What Are You Missing?
- 13 Four Best Practices for Requirements Traceability
- 14 Requirements Traceability: Links in the Chain
- 15 What Are the Benefits of End-to-End Traceability During Product Development?
- 5. Requirements Management Tools and Software
- Overview
- 1 Selecting the Right Requirements Management Tools and Software
- 2 Why Investing in Requirements Management Software Makes Business Sense During an Economic Downturn
- 3 Why Word and Excel Alone is Not Enough for Product, Software, and Systems Development
- 4 Application lifecycle management (ALM)
- 5 Is There Life After DOORS®?
- 6 Checklist: Selecting a Requirements Management Tool
- 6. Requirements Validation and Verification
- 7. Meeting Regulatory Compliance and Industry Standards
- Overview
- 1 Understanding ISO Standards
- 2 Understanding ISO/IEC 27001: A Guide to Information Security Management
- 3 What is DevSecOps? A Guide to Building Secure Software
- 4 Compliance Management
- 5 What is FMEA? Failure Modes and Effects Analysis
- 6 TÜV SÜD: Ensuring Safety, Quality, and Sustainability Worldwide
- 8. Systems Engineering
- 9. Automotive Development
- 10. Medical Device & Life Sciences Development
- Overview
- 1 The Importance of Benefit-Risk Analysis in Medical Device Development
- 2 Software as a Medical Device: Revolutionizing Healthcare
- 3 What’s a Design History File, and How Are DHFs Used by Product Teams?
- 4 Navigating the Risks of Software of Unknown Pedigree (SOUP) in the Medical Device & Life Sciences Industry
- 5 What is ISO 13485? Your Comprehensive Guide to Compliant Medical Device Manufacturing
- 6 What You Need to Know: ANSI/AAMI SW96:2023 — Medical Device Security
- 7 ISO 13485 vs ISO 9001: Understanding the Differences and Synergies
- 8 Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know
- 9 Embracing the Future of Healthcare: Exploring the Internet of Medical Things (IoMT)
- 11. Aerospace & Defense Development
- 12. Architecture, Engineering, and Construction (AEC industry) Development
- Glossary
Chapters
- 1. Requirements Management
- Overview
- 1 What is Requirements Management?
- 2 Why do you need Requirements Management?
- 3 Four Fundamentals of Requirements Management
- 4 Adopting an Agile Approach to Requirements Management
- 5 Status Request Changes
- 6 Conquering the 5 Biggest Challenges of Requirements Management
- 7 Three Reasons You Need a Requirements Management Solution
- 2. Writing Requirements
- Overview
- 1 Functional requirements examples and templates
- 2 Identifying and Measuring Requirements Quality
- 3 How to write system requirement specification (SRS) documents
- 4 The Fundamentals of Business Requirements: Examples of Business Requirements and the Importance of Excellence
- 5 Adopting the EARS Notation to Improve Requirements Engineering
- 6 Jama Connect Advisor™
- 7 Frequently Asked Questions about the EARS Notation and Jama Connect Advisor™
- 8 How to Write an Effective Product Requirements Document (PRD)
- 9 Functional vs. Non-Functional Requirements
- 10 What Are Nonfunctional Requirements and How Do They Impact Product Development?
- 11 Characteristics of Effective Software Requirements and Software Requirements Specifications (SRS)
- 12 8 Do’s and Don’ts for Writing Requirements
- 3. Requirements Gathering and Management Processes
- Overview
- 1 Requirements Engineering
- 2 Requirements Analysis
- 3 A Guide to Requirements Elicitation for Product Teams
- 4 Requirements Gathering Techniques for Agile Product Teams
- 5 What is Requirements Gathering?
- 6 Defining and Implementing a Requirements Baseline
- 7 Managing Project Scope — Why It Matters and Best Practices
- 8 How Long Do Requirements Take?
- 4. Requirements Traceability
- Overview
- 1 What is Traceability?
- 2 Tracing Your Way to Success: The Crucial Role of Traceability in Modern Product and Systems Development
- 3 Change Impact Analysis (CIA): A Short Guide for Effective Implementation
- 4 What is Requirements Traceability and Why Does It Matter for Product Teams?
- 5 Key Traceability Challenges and Tips for Ensuring Accountability and Efficiency
- 6 Unraveling the Digital Thread: Enhancing Connectivity and Efficiency
- 7 The Role of a Data Thread in Product and Software Development
- 8 How to Create and Use a Requirements Traceability Matrix
- 9 Traceability Matrix 101: Why It’s Not the Ultimate Solution for Managing Requirements
- 10 Live Traceability vs. After-the-Fact Traceability
- 11 How to Overcome Organizational Barriers to Live Requirements Traceability
- 12 Requirements Traceability, What Are You Missing?
- 13 Four Best Practices for Requirements Traceability
- 14 Requirements Traceability: Links in the Chain
- 15 What Are the Benefits of End-to-End Traceability During Product Development?
- 5. Requirements Management Tools and Software
- Overview
- 1 Selecting the Right Requirements Management Tools and Software
- 2 Why Investing in Requirements Management Software Makes Business Sense During an Economic Downturn
- 3 Why Word and Excel Alone is Not Enough for Product, Software, and Systems Development
- 4 Application lifecycle management (ALM)
- 5 Is There Life After DOORS®?
- 6 Checklist: Selecting a Requirements Management Tool
- 6. Requirements Validation and Verification
- 7. Meeting Regulatory Compliance and Industry Standards
- Overview
- 1 Understanding ISO Standards
- 2 Understanding ISO/IEC 27001: A Guide to Information Security Management
- 3 What is DevSecOps? A Guide to Building Secure Software
- 4 Compliance Management
- 5 What is FMEA? Failure Modes and Effects Analysis
- 6 TÜV SÜD: Ensuring Safety, Quality, and Sustainability Worldwide
- 8. Systems Engineering
- 9. Automotive Development
- 10. Medical Device & Life Sciences Development
- Overview
- 1 The Importance of Benefit-Risk Analysis in Medical Device Development
- 2 Software as a Medical Device: Revolutionizing Healthcare
- 3 What’s a Design History File, and How Are DHFs Used by Product Teams?
- 4 Navigating the Risks of Software of Unknown Pedigree (SOUP) in the Medical Device & Life Sciences Industry
- 5 What is ISO 13485? Your Comprehensive Guide to Compliant Medical Device Manufacturing
- 6 What You Need to Know: ANSI/AAMI SW96:2023 — Medical Device Security
- 7 ISO 13485 vs ISO 9001: Understanding the Differences and Synergies
- 8 Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know
- 9 Embracing the Future of Healthcare: Exploring the Internet of Medical Things (IoMT)
- 11. Aerospace & Defense Development
- 12. Architecture, Engineering, and Construction (AEC industry) Development
- Glossary
Meeting Regulatory Compliance and Industry Standards
Building complex products and software is a complicated process – and one that oftentimes involves complying with a variety of regulations and industry standards from governing bodies. Ideally, compliance management involves both people and a system that is fully integrated across functions of the organization. The more integrated the compliance management in the development lifecycle, the more likely it is to detect potential compliance issues before they cause long-term harm to companies or consumers.
In this chapter, we look at:
- Best practices for compliance management
- Understanding ISO standards, including their purpose and intention
- Creating a design history file (DHF)
- Failure Modes and Effects Analysis (FMEA)
In this Chapter:
7.1 – A Guide to Understanding ISO Standards
7.2 – Understanding ISO/IEC 27001: A Guide to Information Security Management
7.3 – What is DevSecOps? A Guide to Building Secure Software
7.4 – Compliance Management
7.5 – What is FMEA? Failure Mode and Effects Analysis Process Overview
7.6 – TÜV SÜD: Ensuring Safety, Quality, and Sustainability Worldwide