Manufacturing

Electronic Batch Records (EBR) Software

Ensure compliance and improve efficiency by automating your paper-based systems.

The U.S. Food and Drug Administration's (FDA) Current Good Manufacturing Practices (CGMPs) require proof of proper handling for every step of the production process. Batch records and other types of manufacturing documentation demonstrate this level of accountability. Paper-based systems are cumbersome and error-prone. The right electronic batch record (EBR) software system removes the documentation burden from quality and manufacturing teams. It also improves product quality and key performance metrics.

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Manufacturing Excellence: Unlock Right-First-Time Production with Modern EBR

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Under regulations found in 21 CFR Parts 210-211, EBR must demonstrate the accomplishment of every significant step. This includes production, packaging, and holding of each batch of a drug product. The right solution helps you meet these requirements and adhere to the FDA’s CGMPs.

Electronic batch records make it simple to track and manage production data. In a paper-based process, it can be difficult to ensure forms are routed to the right place in the correct sequence. EBR software eliminates these problems. It helps maintain data integrity, save time, and ensure compliance.

Find out about MasterControl Electronic Batch Records™.

Paper-based batch records are problematic. Illegible entries and other documentation errors happen too often. Efforts are accidentally duplicated. These and other mistakes can cause significant production delays. It’s time to stop pushing paper. Focus on developing a quality product and getting it to market faster.

With a paper-based system, you can never know with certainty that you are reviewing the most recent batch record. Only one person at a time can review a set of documents. Someone needing to look at those documents must track them down. EBR software makes it possible to store accurate, complete data in one central location. Anyone with permission can access the data at any time from anywhere.