Epicor P21 is a robust and comprehensive business management system designed specifically for manufacturers, distributors, and retailers. It is known for its industry-specific features, including support for FDA compliance. In this blog, we take a look at how Epicor P21 helps companies comply with FDA regulations.

The Food and Drug Administration (FDA) is the regulatory agency responsible for protecting public health by regulating food, drugs, medical devices, and other products. Companies operating in the food, pharmaceutical, and medical device industries must comply with FDA regulations to ensure the safety and effectiveness of their products.

One of the key ways Epicor P21 ensures FDA compliance is through its quality management features. The system offers a quality management module that allows companies to define, enforce, and monitor quality control processes. This is critical for companies in FDA-regulated industries because they must maintain consistent quality standards to ensure compliance.

Epicor P21 also enables lot and serial number tracking, which is critical for companies working with FDA-regulated products. Lot traceability is a key requirement of FDA regulations, and the Epicor P21 module makes it easy to track the movement of lot and serial numbers throughout the supply chain. This feature helps companies quickly identify and isolate contaminated or defective products, which is critical to ensuring consumer safety.

In addition, Epicor P21 offers robust document management capabilities, which is critical for companies seeking FDA compliance. The system enables companies to store and manage critical documents such as certificates of analysis, test results, and supplier certificates, which are critical for verifying compliance with FDA regulations.

Another important aspect of FDA compliance is effective record keeping. Companies are required to maintain accurate and detailed documentation of their processes and procedures. Epicor P21 enables companies to easily track and record all transactions and data related to FDA regulations, ensuring compliance with FDA regulations.

On top of these features, Epicor P21 offers built-in reporting and analytics capabilities that allow companies to quickly generate reports for FDA audits and inspections. This helps reduce the time and effort required to ensure compliance and ensures a smooth audit process.

Overall, Epicor P21 is a powerful tool that enables companies to comply with FDA regulations. Its numerous features, including quality management, batch traceability, document management, and robust record-keeping capabilities, make it an ideal solution for companies in regulated industries. With Epicor P21, companies can be confident that they are meeting FDA requirements and delivering safe and effective products.