Best Practices for Software Validation in Healthcare

The healthcare software space is vast and expanding at an epic pace. The global market cap is expected to reach nearly $20 billion by 2027.  It’s no wonder so many startups and big tech companies like Amazon are trying to get in on the medical software game.

Nowadays, thousands of medical software products spreading across many categories are available, ranging from healthcare practice management and electronic medical records (EMRs) to medical billing and scheduling software.  No matter the type of software or where you fall in the healthcare industry, all medical system applications are regulated by the FDA under the guidelines stipulated in CFR Title 21..

The FDA has made validation of medical software mandatory, for understandable reasons. Validation is required to ensure consistent performance, reliability, and accuracy, all of which can affect patient outcomes. Validating healthcare software is also essential for discerning altered or otherwise invalid medical records.

That is, of course, not all. According to Dickson, software validation is paramount to meeting regulatory compliance, primarily in the healthcare industry where security and safety are mandatory.  Moreover, validation helps put in place a sound system that ensures medical software releases, patches, and upgrades don’t cause significant service disruptions or adversely affect care delivery.

If you are in charge of medical software validation, navigating industry standards, validation requirements and regulations can be a complex and arduous task. Not only that, but validation is also often required for ongoing software releases, upgrades, and patches that may roll in multiple times throughout the year.

Clearly, software validation in healthcare isn’t an easy task.  We are here to help. Today, we’ll take you through six key steps and best practices for implementing a streamlined software validation process in the healthcare industry.

1. Review and accept vendor-provided validation documentation

Even if you use off-the-shelf medical systems or get your software from third-party vendors, your organization is responsible for the validation.  That’s a given — but you don’t have to reinvent the wheel.  Most software vendors and software as a service (SaaS) firms offer validation templates and documentation as part of their client packages.

So, if your hospital or healthcare organization is using SaaS, pre-generated validation documentation from the vendor can save you a ton of time.  At the very least, it takes much of the stress out of system requirement testing and document creation.  That can mean all the difference — especially for medical software upgrades validation.

The good point to know is that FDA recommendations often take the least cumbersome approach to software validation. That means you can review and accept vendor-provided validation documentation, and you’re good to go!  After all, no one knows the ins and outs of software and system requirements for it better than the team that designed it.

2. Add vendor’s functional/usage testing to your software validation package

Some healthcare organizations ignore the software supplier’s functional and usage test scripts. Instead, they choose to craft their own functional testing to be in line with their internal organizational requirements and procedures.

Be that as it may, writing functional test scripts for software validation can be a daunting task that calls for in-depth knowledge of the software system in question.  If you didn’t design or create the software in-house, you might spend weeks, if not months trying to learn the nuts and bolts in order to know what tests and protocols to execute.

But why jump through so many hoops when the software supplier has done all the heavy lifting for you?  It would make much sense to include both usage and functional testing provided by the vendor in your validation package.  That will not only save time but also add value and cadence to your validation process.

3. Focus on only testing usable features

The validation process by itself is complicated enough. You don’t want more layers of complexity by testing every bit of functionality and features of the software system.  You can save yourself a ton of effort, headaches, and time by only testing the parts that your organization actually uses.

Of course, it would be wise to deactivate all unused features, lest users find and tinker with them without knowledge of the effects.  For example, you can disable the surgery or mental health management system if your facility doesn’t offer those services.

4. Examine your specific functional, usage, and configuration for risk-based software validation

On a similar but lighter note, you will want to skip the functions your organization doesn’t use for your risk-based validation. The FDA supports this, saying that risk-based validation should be carried out based on the system’s intended purpose.

You must take a closer look at your system’s configuration to call out the critical processes and aspects of your system use.  That might require having a deep understanding of the best practices, standards, and regulations that pertain to your organization specifically and your industry generally.  Your system usage can affect risk more than the functionalities and features built into the software by the supplier.

5. Incorporate validation into your overall software change management strategy

Every change implemented to your software system should automatically trigger software validation.  For instance, validation should be automatically activated when regulated software is updated, upgraded, installed, or patched.  This all relevant aspects are tested, boosting your chances of passing audits and complying with FDA regulations.

Tying software validation to change management can also help you meet GxP standards and make sure that any change made to the software is still in line with your organization’s needs.

6. Validation should focus on the software output

It is best if you only validate the output of your system rather than validating the software itself.  There is a subtle yet crucial difference here.  First of all, you don’t want to validate the software tools themselves, instead focus on how you intend to use those system functions.

Your system testing and validation should gauge whether your organization can use the system’s features to deliver services that comply with the FDA requirements.  Validation is not about testing whether certain functions work.  For instance, if you’re using an EMR, you should validate the patient records instead of the system itself.


Although healthcare software validation traditionally has been time-consuming and complex, you can speed up and streamline the whole process by sticking to best practices.  By adding vendor documentation, testing only the functions you use, assessing specific configurations, and tying validation to change management, you can lighten your validation load and improve regulatory compliance.