Why Regulated Software Needs More Than SAST


by Adam Sandman on

What Is Static Application Security Testing? Why Regulated Teams Need More Than Static Code Analysis

For teams building software for regulated industries, app security isn’t just about finding flaws before release. You’ll also need to show how security controls were considered early, tested consistently, and validated in a way that stands up to internal review, customer scrutiny, and compliance expectations. Many teams treat static security testing as the whole story, but there are additional considerations — especially for regulated sectors. Today, we’ll explore what static code analysis is, what it can (and can’t) do, and how to build stronger and more secure software.

What is Static Code Analysis?

Static code analysis is the broad process of evaluating source code without running the application. The goal is to identify defects, risky patterns, and potential vulnerabilities before they make it further down the software lifecycle. Static code analysis is often performed during implementation as part of code review and can be run early, repeatedly, and at scale. This makes it a great fit for most developer workflows, helping catch issues while the code is still being written and reviewed.

How Does Static Code Analysis Work?

At a high level, static code analysis parses code into a form that tools can systematically examine. Then, the codebase can be analyzed for known risky patterns, logic issues, and security weaknesses relevant to your industry. This process generally relies on techniques like lexical analysis, control-flow analysis, data-flow analysis, and taint analysis.

When it comes to the actual workflow, static code analysis usually looks similar to this:

  • Developer writes or commits code
  • Static analysis tool scans the code without executing it
  • Static analysis tool returns findings in the IDE, pull requests, or pipeline

The result is earlier security testing, fewer costly fixes required, and a more disciplined development process.

Static Code Analysis vs. Software Composition Analysis

Software composition analysis is commonly discussed alongside static code analysis, but they are distinct processes and concepts. Static code analysis focuses on the code that your team is writing (e.g. logic, patterns, data flows, coding decisions, etc.). Software composition analysis focuses on the 3rd-party and open-source components that your app depends on (e.g. vulnerabilities in external libraries).

In other words, a static analyzer may tell you whether your proprietary code introduces insecure patterns, but software composition analysis provides critical visibility into whether a 3rd-party package, framework, or container component has a known vulnerability or risk.

  • Static Code Analysis: Is there something risky in the code we wrote?
  • Software Composition Analysis: Is there something risky in the components we use?

What is Static Application Security Testing?

We’ve discussed the overarching framework of static code analysis, but static application security testing (SAST) is a subset of this methodology. SAST applies static analysis techniques to identify vulnerabilities in source code, bytecode, or binaries before the software is executed. It is the security use case that most developers and testers care about when it comes to broad static code analysis. Think of SAST as the concrete processes and activities that translate the concept of static code analysis into practice.

What SAST is Good At

SAST is particularly adept at catching issues early, which is typically when they are less expensive and disruptive to fix. On top of this, because the application doesn’t need to actually run, teams can scan code while features are still in development, during code review, or as part of automated build checks.

OWASP also notes that SAST is great for scale because it can be run repeatedly across large amounts of software, including as part of nightly builds or continuous integration. These tools also have the precision to point developers directly to the file, line number, and code snippet involved.

Where SAST Falls Short

However, SAST becomes less effective when the question shifts from “what does the code look like?” to “how does the software actually behave?” Put bluntly, many types of security vulnerabilities (especially more modern ones) are difficult to find with static tools. This includes authentication problems, access control issues, insecure use of cryptography, and configuration complexities that aren’t represented in the code itself.

False positives are another well-known challenge with static tools, meaning that teams still need significant human judgment and oversight to determine what issues are real, relevant, and actionable. SAST tools do not have access to environment-specific configurations and can miss things that surface during execution (e.g. race conditions, security misconfigurations, etc.). As discussed earlier in the software composition analysis section, SAST also doesn’t identify vulnerabilities outside the source code.

To be clear, SAST is not ineffective or irrelevant. At the same time, “we scanned the code” is not enough for regulated industries. Teams that work on regulated systems need confidence that critical business workflows, authentication paths, integrations, APIs, and controls all behave correctly in the running system. This means evidence that testing is tied to requirements and that results are traceable. To summarize, static testing does not, by itself, prove that software is secure, reliable, compliant, and functioning as intended.

Why Static Testing Isn’t Enough for Regulated Industries

The more difficult question for modern software development is whether your app can be shown and proven to behave correctly, consistently, and securely in real workflows with real integrations and real data handling paths. Software security is not a single checkpoint, it’s a set of integrated practices across the SDLC to work together to reduce vulnerabilities, mitigate the impact of overlooked issues, and address root causes over time.

Static analysis only sees part of the risk picture, and often misses configuration issues because those are not fully represented in the code. For regulated teams, a clean SAST report is valuable but not necessarily proof of a secure and compliant system. This gap becomes more important when software increasingly needs to stand up to audits, validation processes, customer reviews, and more. This is why most teams carry the mindset that one technique cannot answer every question and surface every issue. Static analysis is foundational, but dynamic validation creates a clear evidence trail that links requirements, tests, and results.

Static vs. Dynamic Code Analysis

On the topic of dynamic validation, the name is relatively self-explanatory — dynamic analysis involves running the code and examining what happens to evaluate dynamic behavior. This helps catch runtime errors, integration issues, logic problems, and security validation gaps that come from the many moving pieces of a modern software system. Regulated teams don’t win by choosing static or dynamic analysis. They win by understanding what each one validates and how they complement each other.

How Automated Testing Bolsters Regulated Software Security

Automated dynamic software testing bolsters regulated software security because it shifts the narrative from a point-in-time inspection to repeated verification of overall behavior. It also directly supports areas where defects become business risks (but where static analysis falls short), such as app logic, security validation, and behavior that crosses component boundaries. Reusable, repeatable automated tests help teams demonstrate critical workflows every time the code changes, instead of manual spot checks.

Rapise is our AI-driven automated testing platform for web, mobile, desktop, APIs, and ERPs. In fact, it can verify that published APIs operate as expected, validating real workflows instead of just scanning source code in isolation. Historically, a major weakness of automated testing was brittleness. However, Rapise 9.0 introduces SmartActions, a self-healing layer that generates patch files so recovered objects can update the repository for future runs. This means more resilient validation while still preserving a reviewable change path — reducing the black box characteristics of certain AI tools.

Static Code Analysis: Necessary but Limited

Static code analysis should be part of every software development pipeline. It acts as an essential layer in a broader strategy, but it can’t tell teams everything they need to know before release. Your team and applications need more than code inspection — they need automated validation and clear evidence that tests map back to requirements and controls. Rapise provides this and offers multi-platform test automation with unmatched test resiliency.

As with our other Inflectra software, Rapise’s systems are compliant with the following global regulations and certifications, so you can rest assured that your data is always protected and secure — including in strictly-regulated industries like aerospace, healthcare, and finance:

Inflectra Global Regulations Compliance

Inflectra ISO/IEC Certifications

GDPR (General Data Protection Regulation)

HIPAA (Health Insurance Portability and Accountability Act)

GAMP (Good Automated Manufacturing Practice)

DORA (Digital Operational Resilience Act)

NIST (National Institute of Standards and Technology) Center of Excellence

FMEA (Failure Mode and Effects Analysis)

FDA 21 CFR Part 11

Eudralex Volume 4 Part I & II

DO-178C (Airborne Software)

ISO 26262

ISO 13485

ISO 31000

ISO 20022

ISO 27001:2013

ISO 9001:2015

IEC 62304 (Cybersecurity for Industrial Automation and Control Systems)

IEC 62443 (Medical Device Software)


About the Author

Adam Sandman

Adam Sandman is a visionary entrepreneur and a respected thought leader in the enterprise software industry, currently serving as the CEO of Inflectra. He spearheads Inflectra’s suite of ALM and software testing solutions, from test automation (Rapise) to enterprise program management (SpiraPlan). Adam has dedicated his career to revolutionizing how businesses approach software development, testing, and lifecycle management.

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