FDA Software Verification vs. Validation

In medical device development, where patients’ lives are at stake, ensuring the safety and efficacy of both software and hardware is paramount. Whether software controls a device, runs diagnostics, or manages patient data, its performance can directly impact patient health. To address these concerns, the U.S. Food and Drug Administration (FDA) mandates a rigorous process for the development, testing, and certification of medical device software.

Two key concepts in this process are software verification and software validation. Though they are often mentioned together, verification and validation serve different purposes and occur at distinct phases of software development. Understanding these differences is crucial for anyone involved in medical device design, development, or regulatory compliance.

The key difference between verification and validation is this: 

Verification is building the product right. 

Validation is building the right product. 

In other words, verification ensures that the software has been developed according to its design specifications. It checks if the product was built right. Validation, on the other hand, evaluates whether the software performs as intended in the real-world environment. It checks if the right product has been built.

Both are equally critical in FDA-regulated medical device software development and ensure the safety and effectiveness of the software before it reaches the market. 

Let’s explore the distinction between these two concepts.

What Is FDA Software Verification?

FDA software verification is the process of evaluating whether a medical device software product meets the specifications set forth during its development. Simply put, it ensures that the product is built correctly (“built right”) according to the design and requirements.

The FDA defines verification as:

"Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled."

Key Elements of FDA Software Verification

• Focus: Internal consistency and correctness of the product design and code.
• Objective: Ensure the product meets design requirements before progressing further in development.
• Timing: Primarily conducted during the design and coding phases, before clinical testing.
• Methods Used: Includes code reviews, static analysis, unit testing, and system testing.

Verification processes focus on whether the software was developed correctly, ensuring that all coding, algorithms, and design meet the predetermined standards and specifications.

Example of FDA Software Verification:

Imagine developing software for an insulin pump. Verification would involve testing the algorithm that controls the dosage calculation to ensure it correctly follows the specifications. Code reviews and unit tests would be used to verify that the calculations are consistent, precise, and do not produce errors under various input conditions.

What Is FDA Software Validation?

FDA Software Validation is the process of determining whether the medical device software fulfills its intended use when deployed in the real world. It answers the question: “Is the right product being built?” Validation occurs after software development to confirm the product meets the needs of the end user or performs as expected in its intended environment.

The FDA defines validation as:

"Establishing by objective evidence that device specifications conform with user needs and intended uses."

Key Elements of FDA Software Validation:

• Focus: External performance, ensuring the product functions correctly in its intended environment.
• Objective: Confirm that the software meets the user’s needs and fulfills its intended purpose.
• Timing: Typically conducted toward the end of the development process, before product release.
• Methods Used: Validation may involve clinical trials, usability testing, integration testing, and performance tests under real-world conditions.

Validation ensures the software functions correctly in its actual use scenario, providing confidence that the device will work safely and effectively in the field.

Example of FDA Software Validation:

In the case of the insulin pump software, validation would involve testing the entire system in a clinical setting, ensuring it functions correctly when managing actual patient data. This might involve usability testing to ensure the interface is intuitive for healthcare professionals, and trials to validate that the device accurately delivers the correct dosage to patients in a real-world environment.                                                                  

The FDA's Approach to Medical Device Software Verification and Validation

The FDA considers both verification and validation as vital components of medical device software development. Failure to adequately verify or validate software can lead to device recalls, patient harm, or even death. As such, the FDA mandates a comprehensive approach through its regulations and guidance.

Key FDA standards and regulations for medical device software include:

1. 21 CFR Part 820 (Quality System Regulation): Requires that medical device manufacturers establish and maintain procedures for verifying and validating software during development.
2. IEC 62304: This international standard focuses on software lifecycle processes for medical devices and is widely accepted by the FDA. This standard builds on ISO 13485 and 14971.
3. General Principles of Software Validation (FDA Guidance): Offers detailed guidelines on how software validation should be conducted, emphasizing that software should meet user needs and intended uses.

The FDA also classifies software according to its risk to patient safety, with higher-risk devices subjected to more stringent verification and validation procedures. Medical device software that is classified as a device or as part of a device must follow these regulations to ensure compliance.

Why Are FDA Software Verification and Validation Important?

Both verification and validation are essential to ensuring medical device software is safe, effective, and compliant with FDA regulations. Skipping or inadequately performing either step can lead to serious consequences, including:

• Regulatory Non-Compliance: Failure to properly verify and validate can result in FDA warning letters, fines, or product recalls.
• Patient Harm: Inadequate testing can lead to software defects, which could compromise patient safety, especially in life-critical devices like pacemakers or drug delivery systems.
• Increased Development Costs: Catching errors late in the development cycle—during validation or even after product release—can be far more expensive to fix than identifying them during verification.

Best Practices for Implementing FDA Software Verification and Validation

To ensure robust verification and validation, medical device companies should follow these best practices:

1. Shift Left by Testing Early: Begin verification as early as possible in the design phase to catch defects when they are easier to fix.
2. Maintain Clear Documentation: Both verification and validation must be well-documented to meet FDA requirements. Document each test, result, and any corrective actions.
3. Use Automated Tools: Utilize automated testing tools for regression testing and code analysis, which can streamline verification.
4. Engage Real Users in Validation: Validation should involve actual users whenever possible, as they can help identify usability issues or unexpected behavior under real-world conditions.
5. Adopt a Risk-Based Approach: The higher the risk associated with a software failure, the more thorough the verification and validation process should be.
6. Interoperate Systems: Integrate software systems to eliminate the manual overhead of aligning data across disconnected systems.

FDA software verification and validation are cornerstones of medical device software development. Both processes are designed to ensure that medical devices perform as intended, safeguarding patient safety and device efficacy. While verification focuses on ensuring the product is built correctly according to the design, validation ensures the final product works correctly in the real world, meeting the end users’ needs.

By following FDA guidance and integrating both verification and validation into every phase of development, manufacturers can reduce the risk of software-related issues and successfully bring their medical devices to market.

How Ketryx Can Help with Medical Device Software Verification and Validation

Ketryx helps with medical device verification and validation by streamlining and automating key processes to ensure compliance with standards like IEC 62304 while improving efficiency and traceability. Here's how:

1. Centralized Traceability:
   
   • Ketryx provides end-to-end traceability by linking requirements, design inputs, risks, and test results in a single system. This ensures that all verification and validation (V&V) activities are well-documented and traceable.
2. Automation of Documentation:
   
   • Ketryx automatically generates compliance documentation, such as traceability matrices, saving teams significant time and reducing the risk of manual errors.
3. Integration with Existing Tools:
   
   • Ketryx integrates seamlessly with tools like Jira, Git, and testing frameworks, ensuring that V&V activities align with existing workflows. Changes in requirements or code are automatically synchronized and reflected in Ketryx.
4. Streamlined Testing:
   
   • Ketryx enables streamlined test management by linking test cases to specific requirements and risks. Teams can track test progress, coverage, and results in real time.
5. Audit-Ready Compliance:
   
   • Ketryx provides audit-ready records for FDA inspections and ISO audits, ensuring that all V&V activities meet regulatory requirements.
6. Risk Management Integration:
   
   • Ketryx links risk assessments with design controls and test cases, ensuring that identified risks are verified and validated appropriately.

With Ketryx, companies experience the following benefits when it comes to V&V:

• Faster V&V Cycles: By automating repetitive tasks and ensuring traceability, Ketryx reduces the time required for V&V activities.
• Reduced Errors: Automation minimizes manual errors, improving the reliability of compliance documentation.
• Regulatory Confidence: Built-in compliance with standards like IEC 62304, ISO 14971, and FDA guidelines helps teams meet regulatory expectations with confidence.

See how Foresight Diagnostics uses Ketryx to release validated software 5x faster.