Understanding FDA Software Validation

According to FDA 21 CFR Part 820.70(i), any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use. In our video CQ’s Software Validation Approach for Life Sciences Companies, we discuss in detail the need for an FDA-regulated company to establish recorded evidence that demonstrates and verifies that the software used meets the compliance and quality management criteria.

The FDA software validation also helps organizations to implement Good Manufacturing Practice (GMP) guidelines. The FDA has compiled comprehensive guidance that is applicable to the validation of medical device software or the software used to design, develop or manufacture medical devices.

Purpose of FDA Software Validation

All companies subject to FDA regulations must validate any software, including the software used as components in medical devices, software that is itself a medical device, and software used in the production of the device or in the implementation of the device manufacturer’s quality system. This is applicable to –

• Any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or any other aspect of the quality system.
• Any computer system used to create, modify or maintain electronic records and signatures.

As such, there are only two rules for FDA software validation:

• All the products manufactured and the processes used must meet the FDA’s production and inventory management criteria
• Every step of the validation process must be documented

As the world of standards moves towards a risk-based approach, FDA reinforces this approach with Computer Software Assurance (CSA). The new CSA understands these challenges and is focused on easing many of the requirements by narrowing them down to risks and critical quality attributes (CQA).

Methods of Software Validation

FDA follows the ‘4Q lifecycle model’, which includes four qualification aspects – design, installation, operational and performance.

• Design Qualification (DQ) focuses on various specifications including user requirement, functional, operational and vendor.
• Installation Qualification (IQ), where FDA validates if the software arrived as purchased and the installation of hardware and software is in accordance with the vendor and user specifications.
• Operational Qualification (OQ) is conducted to test the key operational and security functions to establish the success of the installation and whether the software is performing as intended.
• Performance Qualification (PQ) tests the specified application while focusing on preventive maintenance and performance tests to ensure the software meets all the FDA requirements for functionality and safety.

Here is a checklist for ‘Basic Steps of Computer System Validation & Regulatory Requirements.’

Steps Involved in FDA Software Validation

Software validation is a critical tool used to

• assure the quality of device software and software automated operations
• increase the usability and reliability of the device
• reduce long-term costs and the cost of validation

Broadly, there are five steps to FDA software validation.

Step 1: Create a validation plan that documents various aspects of the software system, its installed environment and project limitations. The plan will also include the testing and acceptance criteria, development procedures and responsibilities of the members of the validation team.

Step 2: Determine system requirements (SRS) by outlining the conditions, including infrastructural, equipment and functional requirements. Perform a risk analysis to identify gaps in the functional requirements.

Step 3: Create a validation protocol and test specifications to uncover potential errors and to check whether all the key features are performing properly.

Step 4: Conduct tests and document results into various categories, including successes, errors and failures.

Step 5: Establish procedures and write the final report that includes a detailed description of support, training, secure backup and recovery, before releasing the system for use within the company.

Benefits of FDA Software Validation

FDA software validation offers numerous benefits that contribute to regulatory compliance, patient safety, product quality, risk mitigation, productivity, trust-building, and cost-effectiveness in developing and deploying software solutions in the healthcare industry. The benefits of FDA software validation include the following:

• Regulatory Compliance: FDA software validation ensures that your software meets the regulatory standards set by the Food and Drug Administration. Compliance with these standards is crucial for obtaining FDA approval and maintaining regulatory compliance throughout the software lifecycle.
• Patient Safety: Validating software helps ensure that it functions as intended, reducing the risk of errors, malfunctions, or other issues that could compromise patient safety. By adhering to FDA validation requirements, you contribute to the overall safety and well-being of patients who rely on medical devices and software.
• Quality Assurance: Software validation improves the quality of your product by systematically testing and verifying its performance, functionality, and reliability. It helps identify and rectify defects or deficiencies early in development, resulting in a higher-quality, more dependable software solution.
• Risk Mitigation: By conducting software validation, you proactively assess and mitigate potential risks associated with your software. This includes identifying and addressing any vulnerabilities, security risks, or potential hazards impacting patient safety or software integrity.
• Enhanced Productivity: Implementing FDA software validation practices streamlines the development process by providing a structured framework for testing and documentation. This can improve efficiency, reduce rework, and faster time-to-market for your software solution.
• Increased Confidence and Trust: FDA software validation instills confidence in your stakeholders, including regulatory bodies, healthcare professionals, and end-users. Demonstrating compliance with FDA standards and validation practices builds trust and credibility in your product, making it more attractive to customers and facilitating market acceptance.
• Cost Savings: While implementing FDA software validation practices requires time and resources, it can ultimately result in cost savings. By identifying and rectifying issues early in the development process, you can avoid costly rework, product recalls, and potential legal consequences of non-compliance.

With CQ EQMS, it becomes easy to automate the process of FDA Software Validation, including all training, guidance, and document management. Additionally, with CQ – it becomes simple to collaborate with relevant stakeholders as needed and manage change in case any issues come up during the validation process.

Request a demo here: https://www.compliancequest.com/lp/eqms/