The Essential Guide to Requirements Management and Traceability
- 1. Requirements Management
- 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 Conquering the 5 Biggest Challenges of Requirements Management
- 6 Three Reasons You Need a Requirements Management Solution
- 2. Writing Requirements
- 1 Functional requirements examples and templates
- 2 Product requirements document template and examples
- 3 How to write system requirement specification (SRS) documents
- 4 Adopting the EARS Notation to Improve Requirements Engineering
- 5 Jama Connect Advisor™
- 6 Frequently Asked Questions about the EARS Notation and Jama Connect Requirements Advisor
- 7 How to Write an Effective Product Requirements Document
- 8 Functional vs. Non-Functional Requirements
- 9 What Are Non-Functional Requirements and How Do They Impact Product Development?
- 10 Characteristics of Effective Software Requirements and Software Requirements Specifications (SRS)
- 11 8 Do’s and Don’ts for Writing Requirements
- 3. Requirements Gathering and Management Processes
- 4. Requirements Traceability
- 1 What is Traceability?
- 2 What is Requirements Traceability and Why Does It Matter for Product Teams?
- 3 How to Create and Use a Requirements Traceability Matrix
- 4 Live Traceability vs. After-the-Fact Traceability
- 5 How to Overcome Organizational Barriers to Live Requirements Traceability
- 6 Requirements Traceability, What Are You Missing?
- 7 Four Best Practices for Requirements Traceability
- 8 Requirements Traceability: Links in the Chain
- 9 What Are the Benefits of End-to-End Traceability During Product Development?
- 5. Requirements Management Tools and Software
- 6. Requirements Validation and Verification
- 7. Meeting Regulatory Compliance and Industry Standards
- 1 Understanding ISO Standards
- 2 What is ISO 13485? Your Comprehensive Guide to Compliant Medical Device Manufacturing
- 3 A Guide to Automotive Safety Integrity Levels (ASIL)
- 4 Compliance Management
- 5 What is FMEA? Failure Modes and Effects Analysis
- 6 What’s a Design History File, and How Are DHFs Used by Product Teams?
- 8. Project Management
- 9. Measuring Requirements
- 10. Systems Engineering
Requirements Verification and Validation for Product Teams
The verification process ensures that software meets specifications. Validation focuses on whether the software meets the expectations and requirements of the end user.
If you’re developing a medical device, this distinction may also be included in regulations and standards, for example:
- 820.30(f): Design verification shall confirm that the design output meets the design input requirements.
- 820.30(g): Design validation shall ensure that devices conform to defined user needs and intended uses
If you’ve heard the terms “verification” and “validation” used interchangeably, you aren’t alone. However, this creates confusion during the testing process, and if you’re building products in highly regulated industries, it’s critical that products perform as expected and expensive errors are avoided.
Unclear and incomplete requirements can be frustrating for developers, and if developers can’t get the required information upfront, they must make interpretations, which aren’t always correct. The result is a higher risk of errors and extra resources spent fixing issues further into the product development cycle.
Understanding the difference between verification and validation and how to use each during product development helps reduce cost, increase efficiency and deliver a product that better fits user requirements.
What is requirements verification?
If you’ve used verification and validation interchangeably in the past, one of the most important things to note is the order. Software verification comes first, followed by validation. But what’s involved with each? Let’s dive into verification first.
Verification tests check to ensure the program is built according to the stated requirements. The verification process includes activities such as reviewing the code and doing walkthroughs and inspections.
Missing requirements or invalid requirements can be discovered during this phase, which can minimize the risk of rework and the cost associated with overruns. It’s far more effective to fix a small bug upfront than in the future when hundreds of lines of code must be identified and corrected.
For example, imagine that you’re driving to a new destination. You might plug that destination into your GPS, which provides directions and the freeway exit number. If you’re looking for exit 10 and just passed exit 1, you quickly know you have nine more exits to go. This is similar to the verification phrase in that using the GPS allows you to check your existing path against the directions.
Another example is entering a formula into a spreadsheet. After entering a few rows of data, you might check the formula and make sure that it’s working. The process of verification is the same in that it allows you to do a quick check before getting too deep into the product development process.
RELATED ARTICLE: Plutora – Verification vs Validation: Do You Know the Difference?
What is requirements validation?
The answer to that question might vary depending on which industry you are in and which type of requirement is being validated.
In general, after you’ve qualified what type of requirement is being validated and completed verification, it’s time to complete validation testing, which confirms the accuracy of the requirements. It ensures that the requirements have achieved the business objectives, meet the needs of any relevant stakeholders and are clearly understood by developers. Validation is a critical step to finding missing requirements and ensuring that requirements have a variety of important characteristics. Software validation addresses the following:
- Correctly outlines the end user’s need.
- Has only one exact meaning.
- Can be modified as necessary.
- Documents the attributes that customers truly need.
- Easily linked to system requirements, such as designs, codes and tests.
Validation isn’t focused on the path that you traveled to arrive at the destination but is instead focused on whether you’ve hit the mark. For example, consider the last example of a person traveling in a car and tracking landmarks, such as exit numbers. Let’s say the goal is to arrive at a hiking trail. A few questions might be asked when you arrive.
- Does the hiking trail look as expected?
- Can I see a marked trail and trailhead sign?
- Does the location meet my expectations?
Validation is focused on the same types of questions. It’s not concerned with how you got there, but that you arrived at the correct location.
If you’re designing a spreadsheet, as we discussed before, you checked that the formula worked during the verification process. During validation, you’re making sure the end product (the spreadsheet) meets the needs of the user.
For example, using the spreadsheet example, maybe we determined we are going to use a spreadsheet to reduce the time it takes us to “x” or reduce the errors we see when we “y”, so we implement a spreadsheet with a bunch of functions, the functions defined by our requirements. Verification asks, does the spreadsheet work per the requirements (“did we build it right”); Validation asks, does the spreadsheet actually accomplish the goals related to x and y (“did we build the right thing”)
And even when a product is fully verified – it still may not meet the needs of the user, i.e., failed validation.
To Learn More About How the FDA Classifies the General Principles of Software Validation, Visit:
Verification and validation: What’s the difference?
As you consider validation vs. verification, you might feel unsure about the differences. What activities fall under the category of validation and which fall under verification, and when should you perform each?
Let’s say that you’re working to create a product and it’s time for verification testing since verification always comes first. During this process, you check documents, design, code, and the program to make sure the software is built according to requirements. The goal is to ensure the quality of the application or design. You might conduct activities such as reviews, walkthroughs or inspections. For example, in the Medical Device Industry, verification usually happens with the “design equivalent” configuration of the product. Validation usually happens with the “production equivalent” of the product per 820.30(g).
Now, it’s time to move on to validation. During this process, you’re testing and validating whether the product meets the needs of your customer. Tasks in this process may include unit testing, integration testing or user testing. As we stated at the top of this article, the verification process ensures that software meets specifications. Validation focuses on whether the software meets the expectations and requirements of the end-user.
Streamlining Collaboration During Verification and Validation with Requirements Management Software
For system engineers, being able to trace relationships between data types is essential. However, there can be a problem with multiple levels of requirements, specification, and verification artifacts all having their own set of stakeholders who are performing a variety of tasks.
The right software solution can simplify complicated situations and enable you to add traceability of the data. You can analyze the “who, what, where, and why” of potential changes and make sure that essential data doesn’t get overlooked. Look for a software solution that does the following:
- Connects test cases from a problem statement to your requirements and design. If you don’t have the ability to do this, you can’t be sure that you haven’t overlooked something critical.
- Connects system requirements to business and stakeholder requirements. If you miss a critical connection, you risk unplanned expenses that may have a ripple effect and create slowdowns in product launches, weaken stakeholder confidence and adversely affect the bottom line.
- Improves decomposition. It’s critical to relate lower-level requirements to higher-level requirements to ensure that components and subcomponents all come together into a functional system. Mistakes in this area may lead to extra costs as you work hard to put the pieces back together and implement changes later in the product development process.
A software solution is a critical tool in helping you manage the verification and validation process and ensure that every engineering activity is connected throughout the entire system life cycle. It’s critical to capture all communication in context and bring stakeholders together in one place for a real-time and comprehensive look into what teams are building and why.
Moving Into the Future
Testing can be one of the most expensive parts of product development, if not properly planned. It’s important to incorporate verification and validation to ensure cost savings and a high-quality product. In the end, if the product doesn’t meet the original objectives, then time, money, and effort will have been wasted.
Fortunately, companies can get products to market faster when people and data stay in sync with product development activities and deliverables. Using innovative requirements management software tools can easily shorten the time from ideation to value creation and performance.
In This Webinar, We Discuss Live Traceability and Its Importance to Compliance
Verification and Validation (V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words “verification” and “validation” are sometimes preceded with “independent”, indicating that the verification and validation is to be performed by a disinterested third party. “Independent verification and validation” can be abbreviated as “IV&V”.
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