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VOOZH | about |
Manufacturing
Electronic Batch Records (EBR) Software
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. An electronic batch record (EBR) software system, such as MasterControl's Manufacturing Excellence, removes the documentation burden from quality and manufacturing teams. It also improves product quality and key performance metrics.
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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
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.
EBR software prevents mistakes from slowing the entire production process.
