ERP (Enterprise Resource Planning) software is a critical tool for businesses in many industries, including those that are regulated by the FDA. These software systems are constantly evolving, with new updates and releases being made available on a quarterly basis. While these updates can bring new features and improvements to the system, they can also have an impact on FDA validation. In this article, we will explore how quarterly ERP software updates can impact FDA validation and what steps companies can take to ensure compliance.
One of the key considerations when it comes to FDA validation is the concept of system changes. According to FDA guidance, any changes made to a system that is used for regulated activities must be evaluated to ensure that they do not negatively impact the system's validation status. This includes changes to software, hardware, and procedures. When a quarterly update is released for an ERP system, it is considered a change and must be evaluated to determine its impact on the system's validation status.
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The impact of quarterly releases on FDA Validation
While most cloud-based ERP systems are updated quarterly, the need for re-validation is commonly misunderstood.
Here is the typical scenario - the processes in the software are validated, then there is a subsequent quarterly software release. Companies will keep their solution in a steady state of validation by having a change control process in place to accommodate the validation. Each software release is judged for impact even if the release does not involve cGMP or regulated functionality. The company will then document that the update was examined and determined to have no impact on the validation and signed off by Quality. If there is an impact, you will rerun test cases to confirm they still execute and no further validation testing is required. If there is a regulated impact, then new test cases will need to be written, tested, and documented. This reduces the burden of revalidation. SAP delivers quarterly releases in the offline mode, allowing for detailed review before release, which further supports the ability to determine the impact and acceptance of the update.
The type of changes made in the update will determine the level of impact on FDA validation. Minor changes, such as bug fixes or small enhancements, may have minimal impact and may not require any significant changes to the system's validation. However, major changes, such as new functionality or major enhancements, can have a significant impact and may require additional validation activities.
To ensure compliance with FDA regulations, companies must have a robust change control process in place. This process should include a review of the update to determine the level of impact on the system, as well as a risk assessment to determine the likelihood of the change impacting the system's validation status. If the update is determined to have a significant impact, the company must conduct additional validation activities, such as testing and documentation, to ensure that the system continues to meet FDA requirements.
Another important consideration is the documentation of the change control process. FDA regulations require that companies maintain records of all validation activities, including changes made to the system. This documentation must be kept up to date and be made available to the FDA upon request.
In conclusion, quarterly ERP software updates can impact FDA validation. Companies must be aware of this impact and have a robust change control process in place to ensure compliance with FDA regulations. This process should include a review of the update, a risk assessment, and additional validation activities if necessary. Additionally, companies must maintain accurate documentation of their change control process to ensure compliance with FDA regulations.