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The Fundamentals of FDA Software Validation


    Software design and development is under increased scrutiny by a "tougher" U.S. FDA. Software validation issues are becoming a growing area of concern by regulatory agencies. Product, production / test equipment, and even the QMS are heavily software / firmware driven in today's manufacturing. Understanding FDA software validation is necessary.

    Software Validation

    The process of establishing recorded evidence that a computer system has been installed correctly, will fulfil users' demands, and performs as intended is known as software validation.

    FDA Software Validation

    When an FDA-regulated company demonstrates and verifies that their software can accurately and consistently provide results that meet established compliance and quality management criteria, this is known as FDA software validation.


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    While the FDA makes guidelines, it does not instruct companies on how to validate their software or what the findings should look like. Rather, it's up to each company to describe how they plan to evaluate their program and to show proof that they did it correctly.

    Even if the software is purchased from a third-party vendor, validation is the responsibility of the company, not the seller.

    Who Needs to Validate Software?

    All companies subject to FDA regulations must validate any software that could potentially affect product quality, safety, or effectiveness.

    Even if a company isn't in a regulated industry, validation is a brilliant concept for everyone who wants to enhance quality.

    Organizations can establish good practice (GxP) or good manufacturing practice (GMP) procedures with FDA software validation. GxP or GMP processes are a set of guidelines that assist manufacturers in reducing risk and ensuring that their products are manufactured and distributed to the highest possible quality standards.

    The How of Validating Software

    Validating software entails capturing proof that a software system fulfils the required standards and quality attributes, has been correctly installed, and will perform as intended.

    You must validate how you intend to utilize your software to create regulated products and/or perform relevant business procedures during this phase. The goal is to not only show that the software will do what you want it to do, but also to identify and mitigate issues that could harm the manufacture of regulated products or their raw materials.

    FDA Requirements for Software Validation

    The following are the only definitive rules for FDA software validation:

    • The products you manufacture and the processes you use must meet the FDA's production and inventory management criteria.
    • The validation process must be documented at every step.

    Your validation plan must show the FDA how your company expects to use its software. This includes identifying the requirements and quality standards that define success, as well as testing out common situations in which the software will be used to manufacture or distribute regulated items.

    The FDA has developed detailed validation project guidance. Not all of the recommendations are applicable to all organizations. Validation is predicated on the degree of risk associated with the product being manufactured: the higher the risk, the more FDA criteria will apply to your validation process, making it more difficult.

    Methods of Software Validation

    The FDA's guidance and criteria may appear daunting at first, but following them can help you not only stay compliant, but also grow your business.

    The "4Q Lifecycle Model" as most validation initiatives are known, follows the same fundamental framework. It consists of four stages of testing and recording the results:

    Design Qualification (DQ): Design specifications, software requirements, functional specifications, operational specifications, and vendor attributes are often included in this document, which is typically provided by the software vendor.

    Installation Qualification (IQ): Your testing and documentation at this point will prove that the software was installed appropriately, in accordance with your company's specifications and user requirements, the vendor's recommendations, and the FDA's instructions. All hardware, software, equipment, and systems are included.

    Operational Qualification (OQ): These tests provide assurance that the software will consistently operate as expected when operating under specified parameters. Because these tests and results include standard features and security capabilities, the vendor can provide them.

    Performance Qualification (PQ): This stage verifies that the program, when installed, will meet your company's requirements. Your testing and documentation prove that the product being produced will meet FDA criteria for functionality and safety, based on the processes and specifications established in the preceding stages.

    Software Validation Steps

    #1 Create a Validation Plan: The "who," "what," and "where" of your validation project are all outlined in your validation plan. It specifies and documents the software system, as well as the environment in which it is installed, the project's assumptions and limits, the testing and acceptance criteria you'll use, the procedures you'll follow, and who makes up the validation team and what their duties are.

    #2 Establish Your System Requirements (SRS): Describe the conditions that must be met in order for the software to work as expected. Infrastructure needs, such as personnel, facilities, and equipment, as well as functional requirements, such as performance and security requirements, system and user interfaces, and the operating environment, are among them. A risk analysis may also be included to discover any gaps in your functional needs.

    #3 Make a Validation Protocol as well as Test requirements: Now you must define what you want the software to accomplish and how you'll demonstrate that it does so. This entails putting together a test plan and test cases. Your test plan explains why and how you'll test and validate the software. Your test cases will re-enact common scenarios to demonstrate that the software can generate a regulated product or carry out a critical business operation. They're made to find as many potential flaws as possible while also demonstrating whether critical functionalities are working properly.

    #4 Conduct Tests and Document Them: This is where you actually run the tests and describe the results, including successes, errors, and failures, based on your test plan and test cases.

    #5 Set Up Procedures and Write You Final Report: After you've finished testing, you'll need to create and revise software-use procedures. The final step before releasing the system for internal usage is to write, review, and approve your final validation report. Support, training, and security backup and recovery should all be included.

    Best Practices for Software Validation

    While the process you use will vary depending on your industry and company procedures, there are some best practices that can be applied to most businesses. These are some of them:

    Link Validation with Change Management: Every time there is a change, such as when a regulated system is installed, upgraded, or updated, FDA software validation should be automatically initiated. This allows you to stay compliant, satisfy GxP or GMP standards, and guarantee that any changes continue to fulfil the needs of your business.

    Test Only the Features You will Utilize: Only test the functionality you require as part of your production, inventory, or quality control system to save time and effort during the validation process. It is good to turn off any features that aren't in use so that consumers don't come across them by accident.

    Validate the Software's Output Rather Than the Software Itself: This is a subtle but crucial difference: you must confirm how your company will use the features rather than the tools themselves. Your tests should be designed to see if the software's capabilities can be utilized to create a finished product that fulfils your demands and FDA regulations, not just to see if a certain feature works.

    Use the Documentation Given by the Vendor: Using the validation documentation given by most major software suppliers is another wonderful method to lighten your load. These materials provide a step-by-step guide to the validation procedure as well as standard information. The vendor can verify functional specs and basic feature products (the OQ stage), but they can't guarantee how your company will use the program (the PQ tests and results).

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