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Devin Brent Ellis

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FDA Compliance

Validating for Success

How validating potential software can ensure the best purchase decision

Published: Wednesday, July 2, 2014 - 00:00

Most of us, at one point or another, have been faced with making a decision to purchase a software application. Whether a simple application to manage your schedule or a more complex quality management software, the challenge is the same: How do you decide if a software application meets your needs if you don’t know how the software truly functions?

Of course, the developer or vendor will describe the solution and demonstrate the application and its features, but will you really retain the depth of knowledge from one demo to another and truly understand how an application will meet your needs? Will it simply be close to meeting your processes or an exact match?

In the end, there is only one way to ensure an application will truly meet your requirements, and that is to validate that the software holds up to the claims made by its developer or vendor. The process of software validation will invariably reveal the major capabilities of a software application based on those claims, and if done correctly, it will go a long way toward helping you understand the product before you make a major purchase decision.

Software validation is the process of determining whether a software application meets the needs of the intended user base, and this is confirmed through a hands-on examination of the software functionality. In some industries, verification and validation (V&V) are commonly required to determine that a software application meets not only the needs of the users, but also whether the application complies with a regulation, industry requirement, specification, or imposed condition. Software validation has been in practice in the pharmaceutical, food, and medical device industries since as early as 1983 and is required for a majority of the software applications implemented.

In the United States, the Food and Drug Administration (FDA) implemented the FDA 21 CFR Part 11 specifically for computerized systems, requiring them to comply with a detailed set of guidelines. As part of the FDA 21 CFR guidelines (similar requirements are imposed in other countries, such as the Annex 11 EU GMP in the United Kingdom or the GAMP5 used throughout Europe), a manufacturer is required to seek out software applications (and developers) that are identified as being in compliance with the 21 CFR requirements, and they must also verify and validate the applications they intend to use in the manufacture of their products. Although software selection takes a great deal more effort for users in these industries, it provides a tremendous advantage because the validation process invariably communicates all there is to know about the software applications prior to and immediately following a purchase. Regrettably, there are few other industries that require this level of diligence when it comes to the software selection process.

To perform a proper validation on a potential software application, one must understand, at a detailed level, how the product is intended to function. To do so may require spending extensive time poring over the user guides and even going as far as taking a training class on the software prior to a validation effort. This may sound like a daunting task, but I assure you, it is nowhere near as discouraging as attempting to implement an unproven application into your processes after you have made the purchase. While those in the pharmaceutical and medical device industries may balk at the hefty validation requirements placed on them, they have a unique advantage in that they were actually forced to substantiate the software functionality before buying. Understanding the capabilities of a software application before purchase will virtually eliminate the guesswork during implementation.

Fortunately, some software providers offer validation guidelines with their applications that will aid in understanding the product, and in some cases, these offerings will actually guide the user through specific events to trigger the desired functionality. It is also a good sign when a developer or vendor will allow the full functionality of the software application to be installed on premise (or in a hosted environment), and thus allow the users to truly test drive the product prior to purchase.

I know what you’re thinking: “Who has the time to learn an application before they purchase it and then install and walk through it, ensuring it does everything it says it should?” And you’re right to some extent—it is a lot to ask of a busy team to sit down with a product and learn it at that level. But ask yourself this: Will you or your team have any more time after you purchase? Wouldn’t you rather know up front, prior to spending the money, if the software will provide all the functionality you require? It is unfortunate, but too often end users will make the decision to purchase a software product before it is truly proven.

Certainly, you should not need to perform an extensive validation for a simple application or for well-known software applications like spreadsheets or document editors. If, however, you are looking to purchase specialized software, like a quality management application, you should take the time needed to determine if it will do all you require of it.

The following are some tips for selecting and identifying good candidates for the purchase of larger, specialized software applications.

• Because you will want to get to know the software in as little time as possible, look for developers or vendors that comply with multiple industry standards (like ISO and FDA 21 CFR). Even if you yourself do not need compliance in those areas, the developer will often have certificates and validation guides for its products that will help you to establish a validation path and provide specific guidance on its product’s functionality. Additionally, ensure the potential software providers will allow a fully functional version of their product to be installed on premise or in a hosted environment. This not only demonstrates confidence and good faith on their part, but it also gives you full access to the product for your validation efforts.
• Identify all of your company’s self-imposed or customer-imposed requirements, and consolidate them into a single list so that it will be easy for everyone involved in the software purchase to identify the features the potential software applications will need to meet. These are typically compiled on a request for proposal form (or RFP). This list will not only help you narrow down the choices, it will also be used in the hands-on validation of the final product selection.
• Assemble a validation team, including potential end users, and ensure they have access to the compiled requirements list, the product demo installations, and any product documentation that will help them understand the product’s functionality.
• Be sure to set the expectations of the team and be realistic about your final choices; unless you are looking for a customized solution, even specialized software applications can’t be expected to meet 100 percent of a company’s needs out of the box.

In the end, by taking the time to identify all your needs, and involving product selection and validation teams, you will be ensuring that everyone is familiar with the requirements and has had a voice in the selection process. This will go a long way toward identifying the best product options, and everyone on the validation team will be familiar with the capabilities of the software when implementation begins.

As a software developer, we want our potential customers to install and validate our products to make certain their needs will be met; in fact, we validate and test our software prior to release to ensure it stands up to very specific industry requirements. Sure, we want companies to purchase our products, but not at the expense of damaging our reputation because they were not an ideal fit. Too often, potential customers do not expend the necessary effort to select the right solution for their needs, and the developer will often take the blame for a failed implementation. In fact, many end users will often select a product simply because they like the user interface more than that of a competing product. Although the user interface is certainly important, it does not by itself warrant buying a software package meant to meet very specific needs. In order to ensure our customers will continue to use our products and any future revisions, we are adamant in most cases that they truly evaluate and choose our product on the merit of its capabilities, and not because it had the right amount of cornflower blue in the window headers.

When all is said and done, buying software will always require some diligence. Specialized software applications have grown extremely complex over the years, and it is not enough anymore to narrow the search to a few candidates and then simply select them based on the developer’s claims. Whether you have several solutions to choose from or just a few, it will behoove you to take the time to truly validate the best candidates and come to know it at a level typically reserved for the implementation and training stage. The software validation process will consistently reveal the major capabilities of a software application and ensure you always make the best purchase decision possible.

Devin Brent Ellis is the director of client solutions at CyberMetrics, a Quality Digest content partner.


About The Author

Devin Brent Ellis’s default image

Devin Brent Ellis

Devin Brent Ellis is the Director of Client Solutions and Development for CyberMetrics Corporation, a foremost developer of quality and maintenance management software solutions utilized by more than 12,000 companies around the world. He has nearly 20 years’ experience in software support and development and has helped hundreds of clients achieve success with their product implementations.