Data Sheet
Batch Manufacturing Records
You will learn:
- The key benefits and features of MasterControl Electronic Batch Records.
- How you can track manufacturing processes and deviations.
- Essential compliance features, including audit trails and training management tools.
- Tips about improving data integrity and system integration.
About This Asset
Batch manufacturing records help manufacturers show compliance with Current Good Manufacturing Practices (cGMP) outlined by regulatory authorities. Electronic batch record (EBR) systems offer a high level of control and visibility in real time that paper-based systems cannot. Improve your efficiency by automating shop floor processes and ensuring complete, accurate records. Learn more about MasterControl EBR software in this data sheet.
EBR Software Videos
MasterControl Manufacturing Excellence helps companies around the world automate their batch record processes to meet regulatory requirements.
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, like MasterControl Manufacturing Excellence, 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, such as MasterControl's Manufacturing Excellence, eliminates these problems. It helps maintain data integrity, save time and ensure compliance.
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, like MasterControl Manufacturing Excellence, makes it possible to store accurate, complete data in one central location. Anyone with permission can access the data at any time from anywhere.
Free Resources on EBR Software
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The Competitive Advantage of Going Paperless with an EBR software
cGMPs require extensive EBR systems documentation. This includes the following: Batch dates Identity of major equipment/lines used Components/materials used and their weights and measures In-process and laboratory control results Complete labeling control records Sampling Identification of personnel supervising or checking each step
Comply With 21 CFR 210-211
Pharmaceutical companies have traditionally used paper (hard copy) to maintain production batch records. With the advent of 21 CFR Part 11 in 1997, the FDA began to accept EBR systems like MasterControl Manufacturing Excellence. When you adopt an EBR software system, it must be in compliance with regulations found in 21 CFR Parts 210-211.The requirements include a time-stamped audit trail, reporting, electronic signature and security requirements.
MasterControl EBR Software Reviews
Achieve right-first-time production with a Complete EBR Software like MasterControl's Manufacturing Excellence.
EBR software prevents mistakes from slowing the entire production process.
Download the Product Data Sheet