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  • Writer's pictureJohn Hannan

21CFR Part 11 Compliance in your ERP System

Understanding 21 CFR Part 11 compliance is essential to any software selection process within the Life Sciences Industry. This regulation, also known as FDA's Title 21 Electronic Records and Electronic Signatures (ERES), lays out specific requirements regulated industries must meet to ensure electronic records' accuracy, consistency, and safety.


So what does this mean? Ensure that your ERP system can support the necessary infrastructure to meet 21 CFR Part 11 compliance. To do that, it must provide complete documentation of all process controls, records integrity, data integrity and accuracy assurances, and authentication and authorization processes.


Implementing 21CFR Part 11 Into Your ERP System

An ERP system is designed to manage a business’s data and processes. But did you know that if your company produces, stores, or transmits certain types of data (for example, pharmaceutical products or clinical studies), it might have to comply with regulations such as 21 CFR Part 11?


It's important to know what type of ERP system works best for meeting the requirements of 21CFR Part 11. Generally, cloud-based solutions are the most reliable and secure way to handle sensitive data—as they're not only password protected but require additional authentication methods. But on-premise solutions can achieve compliance, too; IT teams need closer monitoring and manual management to meet the standards.


Other enterprise solutions offer out-of-the-box capabilities that make it easier to comply with 21 CFR Part 11. For instance, SAP has built-in features in their S/4HANA cloud software that can help streamline compliance processes such as user authentication and audit trails. Others, like Microsoft Dynamics and Oracle NetSuite, offer comprehensive regulatory compliance support for different industries, including life sciences and healthcare.


Types of ERP Software Supporting 21CFR Part 11 Compliance

When it comes to ERP software, there are a few different types that offer 21CFR Part 11 compliance. Let’s look at some of the more popular solutions and how they can help you ensure all internal operations and data remain compliant.


Oracle NetSuite

Oracle NetSuite’s ERP solution is all about maximizing performance and accelerating innovation. It automates compliance using sophisticated controls, identity management, and workflow design to ensure accuracy throughout your processes. Oracle sort of steps up your game by adding advanced analytics capabilities with machine learning so you can transform your compliance operations. And make them more efficient — plus increase visibility into activities, such as data reconciliation or identifying unanticipated issues or changes.


Microsoft Dynamics

Microsoft Dynamics offers a range of features that help you comply with 21 CFR Part 11 via the Microsoft Workflow-based integration platform Microsoft Flow. This allows you to create automated workflows by connecting other Microsoft applications to EUM/ERP systems so you can more easily manage and monitor activities across different systems from one centralized location.


SAP Ariba

SAP Ariba, a procurement system that can be integrated with SAP S/4HANA, enables companies to manage their digital spending effectively and achieve tremendous financial success. This ERP system helps with 21 CFR Part 11 compliance by supporting automated electronic signatures, which streamline digital processes. Hence, no manual steps in the workflow could result in errors or mistakes. Additionally, data integrity is maintained through automatic versioning controls so everyone in the chain is always aware of who is responsible for what step in the process.


No matter which type of ERP software you use, you can ensure that your business operations comply with 21 CFR Part 11 regulations when appropriately implemented. Consult an experienced professional if you have any questions about how to best use your system for regulatory compliance!


Benefits of 21CFR Part 11 Compliance in Your ERP System

Compliance with 21CFR Part 11 allows your organization to have better control and safeguards for your data and business operations. Here are a few of the benefits of having compliance in your ERP system:


Regulatory Compliance

Having an ERP system compliant with 21CFR Part 11 ensures that all of your processes meet the regulatory standards set by the FDA, which means that you can stay up-to-date with all related laws and regulations for the industry. This helps you maintain a good reputation, remain competitive and ensure product quality.


Data Security

Since 21CFR Part 11 requires systems to protect data from unauthorized access, it can help provide greater security for sensitive information. Only those granted access can view, modify or delete data within the ERP system, helping limit data leakage and theft.


Improved Efficiency

When you have 21CFR Part 11 compliance in your ERP system, it makes it easier to build out robust audit trails to track back any changes made within the system quickly. This reduces manual work and helps streamline processes, ensuring more accurate reporting and improved efficiency across the organization.


Investing in an ERP system compliant with 21CFR Part 11 can ensure better regulatory compliance, improved data security, and increased efficiency for your organization.


Questions to Ask Your Service Provider on 21CFR Part 11 Compliance

When it comes to being compliant with 21CFR Part 11, there are a few key questions you should ask your service provider. First and foremost, you want to make sure that your ERP software solution is validated. This means that the software has been tested to ensure it meets the requirements of the FDA.


You also should be asking questions about the following:

  • Security of user authentication

  • Access control processes

  • Data integrity

  • Data retention periods

  • Electronic signatures and their use

  • Audit trails and security protocols

Your ERP provider should also be able to answer any other questions you might have about what specific measures they are taking for 21CFR Part 11 compliance. A reputable provider should have robust processes in place and be able to give detailed answers on what protective layers they’ve built into their system.


The Bottom Line on 21CFR Part 11 Compliance

Knowing the compliance standards within ERP software and how they can support your business’s overall goals is essential. While the 20 CFR Part 11 compliance standard may seem daunting, taking the proper steps to maintain compliance can help ensure you run a successful enterprise that aligns with all pertinent regulations.


ERP compliance is a critical component of any modern business, and having the right compliance protocols in place can help keep your business running smoothly and securely. For more information about ERP software compliance with 21 CFR Part 11, follow #JohnHannanLLC on LinkedIn for updates!

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