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How to Accomplish FDA Validation for ERP Software

Updated: 3 days ago

Implementing ERP software for GxP processes into an FDA-regulated business or organization requires FDA validation. The Food and Drug Administration (FDA) requires that certain technologies used in the manufacturing and storing of products, such as pharmaceuticals and medical devices, be validated before they are released to the market. Whether you are implementing Microsoft Dynamics 365 (D365), Oracle NetSuite or another capable ERP system, the principles of FDA Validation remain the same.


Validation is proving that a system meets the intended purpose it was designed for by confirming that the system works properly. Validating an ERP system involves testing and validating its various components, including security controls, configuration settings, processes, functions, and reports.


Keep in mind that the purpose of FDA Validation is to ensure that the tracking and traceability features of a system exist and are reliable so that if there is ever a problem or an investigation, the required information will be there. Understanding this purpose helps when completing the FDA Validation, as you can align your actions with the end goal.



Steps Involved in Validating Software?

The FDA validation process must follow strict protocols to ensure compliance with applicable regulations and industry standards. These protocols typically involve a combination of manual review and automated tools to ensure accuracy. To validate an ERP system successfully, companies must adhere to several best practices, including:



Risk Assessment

Companies should conduct a comprehensive risk assessment prior to implementing any changes or new processes within their ERP system. This includes evaluating any potential risks associated with user access control, data storage, and integrity issues and any impacts from changes in business rules or other critical systems components.



Change Management Processes

All changes to the ERP system must be carefully managed according to predefined processes to ensure no unexpected problems arise. It is also important that all stakeholders in change management understand their roles in the validation process and how each step will affect other parts of the system.



Testing & Validation

The FDA validation process involves extensive testing of all aspects of the system, including security measures, database architecture, performance criteria, and reporting capabilities.


Once all tests have been completed. The testing and validation are commonly separated into 3 parts:

  • Installation Qualification (IQ) – This is the installation of the hardware and software used to run the ERP system. The good news for many ERP implementations these days is that when you are running a SaaS model from a reliable ERP vendor, the hardware (yes, even in the cloud, there is hardware out there somewhere!) itself does not need to go through the IQ portion of the FDA Validation process. Companies like Microsoft, SAP, and Oracle have demonstrated to the satisfaction of the FDA that their hardware installations meet requirements. The process to deploy the software to the organization's instance can go through an IQ. Of course, there are considerations and exceptions when we start talking about modifications and integrations, but the point is this is the easiest of the 3 parts of FDA Validation.

  • Operational Qualification (OQ) – This is a test of business processes and system procedures through Test Scripts that shows that the system is doing what it is supposed to do. This is the meat of the process and the most time-consuming. An ERP implementation where there are many GxP processes to validate (which essentially can be everything but finance) can require a whole team and weeks into months to conduct this phase. Given the investment, it is important that Validation Master Plan (VMP) clearly outlines how these tests will be conducted, and everyone involved follows that guidance.

  • Performance Qualification (PQ) – The PQ ensures that the software and procedures will work in the environment in which they are going to be used. This means simulating as much as possible through the use of actual end-users, equipment (i.e. barcode scanners), and work locations. It may mean going to different receiving docks or warehouse locations and running the same tests multiple times with multiple people interacting with the system at the same time. This should also be detailed in the Validation Master Plan (VMP).



Document Retention & Control

Companies must keep track of all documents related to their ERP system’s validation process to prove regulatory compliance when external auditors or agencies such as the FDA request. Signatures, dating, and even the correction of any mistakes within all need to follow a protocol. In addition, companies should also have established procedures for monitoring ongoing operations and updating existing documentation regularly so as not to become out-of-date over time due to changes in regulations or other factors impacting quality assurance.



How Can You Ensure Your Software Is Validated?

Ensuring that software is validated is important in software development and release. Software validation helps ensure it meets the expectations and requirements set out for it and reduces the risk of costly bugs and errors once it is released into the wild. Here are some tips for ensuring your software is properly validated:


Develop a Validation Master Plan (VMP)

Before any testing, you must develop a thorough test plan outlining all the steps required to validate your software and how the program will be operated. This Validation Master Plan should include everything from feature testing to usability tests to compatibility checks with different operating systems. Ensure all areas are covered in your test plan so nothing gets missed when validating the software. This is the road map for how you will do the Validation and should be as detailed as possible.



Utilize Automated Tests

Automated tests can save time validating your software as they can quickly run through thousands of lines of code or even simulate how a user interacts with the program. Plenty of tools are available to help automate testing, some of which come with ERP systems natively, so make sure you take advantage of them whenever possible.



Test Across Different Environments

Testing across different domains (e.g., different hardware, operating systems, etc.) is essential when validating software since these variations can cause unexpected issues during use by real users after launch. Ensure that all test plans account for variations between platforms, devices, browsers, etc., and provide feedback accordingly so issues can be identified and addressed ahead of time.



Set Up QA Processes

Quality assurance (QA) processes are key to ensuring proper validation as these allow you to keep track of bugs found in various stages throughout the process and help prevent them from becoming bigger issues later on down the line. Set up regular QA cycles for each phase of development to ensure everything has been thoroughly tested before release into production environments.



Involve Users

Involving users during validation testing can help identify real-world problems and potential issues before releasing a product into production. Invite beta testers or power users willing to offer constructive feedback on the product and use this data in conjunction with automated tests to properly validate that all expected functionality works as expected across all scenarios where the software might be used.



FDA Validation Done Better At John Hannan LLC

Talk with John Hannan LLC for reliable and comprehensive FDA validation advisory for your ERP software. With our help, the guesswork is removed from the validation process

If you have any questions about FDA validation and ERP software? Please leave them below; the John Hannan LLC team will happily answer them.

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