Quality and manufacturing managers know that a method for documenting and reviewing accurate batch records is the single most important element in a pharmaceutical manufacturing and quality process. That’s because, without accurate batch records, even a well-designed quality system will be vulnerable to audit findings and warning letters. After all, nobody wants to receive a
Category Archives: electronic batch records
Electronic Batch Records (EBRs) occupy a unique position in the complex world of pharmaceutical manufacturing, bridging the realms of Manufacturing Execution Systems (MES) and quality management and compliance systems. Traditionally viewed as records of production activities, EBRs have evolved into much more than mere documentation. They embody instructions, standard operating procedures (SOPs), recipes, and records,
If you manage your batch records using a manual process, you know how time-consuming and challenging it can be. Electronic batch records systems are designed to make it easier to manage batch records, ensuring your products are of the highest quality and are compliant with regulations. We tackled the topic of electronic batch records in