3 Valuable Things to Consider About Software Validation: Should you revalidate your SaaS tools?

Software validation is a cornerstone of quality assurance. It’s designed to account for risk, protect customers, and ensure that the digital tools your business depends on operate reliably and effectively. The principle is simple: when in doubt, validate.

But the rapid evolution of SaaS (Software as a Service) platforms complicates the picture. Unlike traditional on-premise software that might release major updates once or twice a year, SaaS products are constantly changing—sometimes weekly or even daily. Updates roll out in real time, often in direct response to user feedback.

This raises a critical question: does every update require revalidation?

The answer is nuanced. While you don’t need to revalidate every small release, ignoring the unique risks SaaS introduces can leave your business exposed. Understanding the purpose and practice of software validation in this modern landscape helps teams adapt without sacrificing compliance.

What is software validation, what is the goal? 

At its core, software validation is the process of ensuring that the systems and tools you use perform consistently, reliably, and in line with documented requirements. In regulated industries like medical devices, pharmaceuticals, and healthcare, this isn’t just best practice—it’s a compliance mandate.

The goal of software validation is twofold:

1. Risk reduction – Minimizing the likelihood of errors that could compromise quality, safety, or compliance.
2. Operational reliability – Ensuring your processes run smoothly so you can focus on delivering products and services, not fixing system failures.

Traditionally, validation has been a structured process. Requirements are defined, risks are analyzed, testing is completed, and documentation is archived. Updates are infrequent, so validation is performed on a predictable cycle. SaaS, however, doesn’t play by those rules.

Why SaaS Requires a Different Approach to Software Validation

Because SaaS updates are continuous, applying traditional validation practices would mean near-constant revalidation—a burden that’s neither realistic nor scalable. Instead, SaaS demands a more adaptive approach to validation: one that balances agility with risk management.

Compliance still requires that companies adhere to their quality management systems (QMS) and regulatory guidance, but how validation is executed must evolve. That means designing processes specific to SaaS products that focus on risk-based validation rather than update-based validation.

3 things you should be considering:

Here are three critical areas companies should focus on to keep validation practical and effective:

1. Revisit Risk Analysis Regularly

Instead of tying risk reviews to the software release schedule, revisit your risk analysis periodically throughout the year. Ask:

• Have your requirements changed?
• Have new business needs emerged?
• Have software updates or operational changes introduced new risks?

This proactive review ensures you are addressing risks as they arise, not just during annual cycles.

2. Build Continuous Checks into Daily Use

Don’t rely solely on formal validation cycles. Incorporate checks of critical requirements into your everyday processes. These real-time validations surface issues quickly, whether caused by software updates, human error, or unexpected workflow changes.

Example: Automate alerts when data doesn’t sync correctly between your SaaS platform and your ERP system. These ongoing checks provide early warning signals before problems cascade into compliance failures.

3. Account for Business and User Realities

Software validation isn’t just about features—it’s about how users interact with them. Even validated tools can fail if users aren’t properly trained or workflows haven’t adapted. Ask yourself:

• Are users aware of new features and their impact?
• Do SOPs (standard operating procedures) need updating?
• Are there new industry risks (cybersecurity, data privacy, etc.) that weren’t present when validation was first performed?

Training and communication are just as critical as validation itself.

Building SaaS Validation into Your Quality System

To truly address SaaS realities, build a framework into your QMS that explicitly accommodates continuous delivery models. This framework should:

• Define how risks are evaluated outside of update schedules.
• Specify when revalidation is required (e.g., significant functionality changes vs. minor patches).
• Ensure documentation is created to demonstrate ongoing review, even if revalidation isn’t triggered.

For instance, you may decide that only updates impacting validated business-critical requirements require formal revalidation, while cosmetic updates do not. What matters most is consistency: always follow your documented procedures and align them with regulatory expectations.

When Revalidation Is (and Isn’t) Necessary

Not every SaaS update warrants revalidation. Minor bug fixes, UI tweaks, or performance improvements usually don’t affect critical business functions. However, major changes to workflows, integrations, or data handling may introduce risks that must be addressed.

Even when revalidation isn’t required, maintaining records that show ongoing monitoring is a smart strategy. This documentation demonstrates to auditors that you’re proactively managing risk and ensuring your software validation remains current.

Final Thoughts on Software Validation in SaaS

Software validation remains as important as ever, but SaaS requires a shift in how businesses approach it. By emphasizing risk analysis, building continuous checks into daily use, and updating your QMS framework to account for SaaS realities, you can reduce compliance risk while maintaining agility.

Validation is not about blindly testing every release—it’s about protecting your business and customers by ensuring that your systems reliably support critical processes. When done right, software validation transforms from a regulatory burden into a foundation for trust, efficiency, and long-term resilience.

At Beacon we provide release notes with every release and link to documentation to teach you how new functionality works, to assist you in determining if there is a need for revalidation. If you’d like to learn more, reach out to schedule a demo.