The Software Validation Process Doesn’t Need to be Complicated

By Ryan Vice | Posted on October 15, 2020


The software validation process is an integral part of software development; it determines whether software successfully meets the needs and expectations of those using it. Software validation is required by law in many cases, but regardless of whether you have to validate your software, you definitely should. Purchasing custom software typically takes more time and effort than buying a standard SaaS product, so that software better work precisely the way you want; software validation ensures that it does. 

software validation vs. software verification

While software verification poses the question, “did we build the right product?” software validation asks, “did we build the product right?” The distinction may seem trivial, but in practice, those are two very different questions. Verification checks that software is developed according to the developer’s plans and specifications, but it doesn’t consider how useful that product is for the customer. While verification looks at the intricate inner-workings of a software, validation focuses more on the big picture – is it useful in the ways it was supposed to be? Accurately developed software can be verified, but it isn’t valid until it meets the stakeholders’ needs. 

What Can Software Validation Do For You?

Ensure That Software Is Developed Correctly 

Both validation and verification help safeguard software from mistakes through a series of tests. Unfortunately, it’s infeasible to test every possible input – the software may very well become obsolete in the time that would take. However, it isn’t typically necessary to test every input. We can design test cases to discover as many issues as possible, so fewer tests need to run. Validation tests help ensure the software is developed correctly by:

  • Identifying issues with the software before its deployment
  • Helping guarantee quality and reliability.
  • Making sure the software behaves predictably
  • Making sure the software is compatible with its environment 
  • Identifying risks so that businesses can make educated decisions
  • Helping ensure that the project is finished on time and within budget

Meet Your Business Needs

A company hoping to develop software should be inclined to test the software’s validity – it’s just good business. The software validation process places focus back on the purpose of a system: the reason you chose to purchase software in the first place. Often, the software’s goal is to automate business operations, and developers can tailor custom software to perform those processes in the most efficient way possible. For a business, that means operations happen faster, and they do so using fewer resources (such as human effort and money).

Satisfy Regulatory Requirements 

For some industries, software validation is a requirement, not a suggestion. This is especially true for anyone who operates under the watchful eye of the FDA. Regulated products tend to have a more considerable impact on health and safety than non-regulated goods. Accordingly, they are required by law to meet specific standards for quality and compliance. The FDA mandates validation for the following types of software before they reach the market: 

  • Medical Device Software
  • Production Software (systems used to produce FDA regulated products)
  • Quality Management Software
  • Software for FDA-Regulated Records (software used to create, modify, maintain, archive, retrieve or transmit FDA-required records)

While the FDA is very explicit on what types of software need validation, the actual recommendations are somewhat vague. They offer little guidance on how to test the software or what the results should look like. This means it’s primarily up to the business developing software to design tests and prove its validity. 

Vice Makes Our Clients Part of the External Validation Process

The internal software validation process assumes that the development team accurately understands the stakeholders’ intentions. When it comes to external validation, we toss those assumptions out and let the client decide if the software meets their needs. It’s common to leave external validation for the final stage of a project, but at Vice Software, we believe our clients have the right to shape their software from the get-go. We know just about everything there is to know about software, but no one understands your business and what it needs better than you do.  


It doesn’t matter how well software works if it doesn’t efficiently accomplish what it was supposed to for the company. The software needs to work, and do so in the environment people will be using it. Testing how compliant and compatible software is with a company’s current systems is essential for the software validation process. The software doesn’t exist in a vacuum, so we shouldn’t test it in one either.   

Workflow Testing

The most valuable information you can bring to those developing your custom software is knowledge of your company’s business processes. Understanding the operations you’re planning to automate will help us design workflow tests that gauge the software’s effectiveness accurately. A workflow is a series of steps to arrive at a given outcome, such as onboarding new employees. Workflow testing involves checking to ensure there are no hiccups to completing those steps. 

Transparency and Communication 

To foster a collaborative environment, we make sure our clients are always in the loop. We set up a dedicated Slack channel for every project so our clients can start a dialogue and receive important updates. We also utilize GitHub, which lets our clients see into the codebase for their new software. Our clients play a significant role in the external software validation process throughout development. Because of this, we can find issues much earlier on, and our clients get more say in how their software looks and behaves.   

Lean Development 

Our lean development model won’t just save money and speed things up – it also reduces the risk of over-developing software, which can be disastrous, costly, and time-consuming. To combat this, we only build what you need. 

We start by creating a scaled-down prototype so clients can see the design and help make decisions before we begin developing. Then, we build the barest version of an application, containing only the most essential components. This “walking skeleton” is useful for many reasons: adding and testing new features in a live environment lessens the risk of bugs, we can develop the software without blowing the budget, and clients have a workable app to show stakeholders much earlier in the process. From there, we build on your application until it blows away your expectations, working piece by piece to ensure that every feature functions the way it is supposed to. 

Get Started Today

At Vice Software, we understand how valuable our client’s insight is. That’s why we work with you during the software validation process – so the application you get is everything you dreamed of and more. We’re not the type to say, “we’ll get it to you when we get it to you,” we’re hands-on. If you need custom software, tell us your ideas! We’d love to make them happen.

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