Batch Records

BMR & BPR

What is BMR and BPR in pharma?

Imagine you’re a pharmacist creating a life-saving medication. Every single dose needs to be identical, ensuring the correct quality and safety for each patient. That’s where batch records guide you in quality manufacturing. But within this process two crucial documents play a vital role-  Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs). Batch Manufacturing […]
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why is batch record software

Why is Batch Record Software required? Best Batch Record Software for Mid-size Pharma Manufacturing Companies!

In the fast-paced world of pharmaceuticals, every step of the production process needs to be precise, efficient, and compliant with strict regulations. This is where batch records come in – detailed documents that act as a roadmap for your product’s journey, from raw materials to finished medications. However managing these records manually can be a […]
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Unlocking Efficiency and Compliance with Electronic Batch Records

The requirement for simplified procedures and strong regulatory compliance has never been more crucial in the ever-changing environment of the manufacturing and pharmaceutical sectors. Electronic Batch Records (EBRs) arise as a game changer, revolutionizing how enterprises manage and document their manufacturing operations. In this blog, learning about what they are, how they work, and how they’re changing […]
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Automation and paper elimination in pharmaceuticals with electronic batch records

Automation and paper elimination in pharmaceuticals with electronic batch records

Batch Records Software Process XE batch records software workflows are 100% configurable. No coding required. What is a Batch Record? A batch record is a record of the history of a manufactured product. It comprises processing instructions to assure its safety, quality, and GMP compliance. As a result, pharmaceutical businesses choose to use Electronic Batch Record (EBR) […]
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the-stracture-of-batch-records

The Structure of a Perfect Batch Record

Batch Record When it comes to pharmaceutical manufacturing, ensuring quality and safety is of utmost importance. Adhering to current Good Manufacturing Practices (cGMP) is mandatory as they form the foundation for producing high-quality products. In most countries, meeting cGMP requirements is a prerequisite for selling pharmaceutical products in their respective jurisdictions. Given the high impact of the […]
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the-art-of-crafting-batch-manufacturing-records

The Art of Crafting Batch Manufacturing Records

A batch manufacturing records serves as a comprehensive document, capturing the entire manufacturing history of a product batch. This terminology finds widespread application in the Pharmaceutical & Chemical industries and is a key reference in various pharmaceutical and food regulatory agency guidelines. According to the US Food and Drug Administration’s definition, a batch represents a specific quantity […]
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Understanding Manufacturing Batch Records

Manufacturing batch records are documents that provide a detailed record of the production data for a specific batch of products. These records are typically maintained by manufacturers in industries such as pharmaceuticals sectors where quality control is essential. Here’s all you must to know about them. The pharmaceutical manufacturing business intends to comply with current good manufacturing […]
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ELECTRONIC-BATCH-MANUFACTURING-RECORDS

How should an electronic batch manufacturing record be prepared?

Electronic batch manufacturing records (EBMRs) are digital versions of paper-based batch records used in the manufacturing industry. They serve as comprehensive documentation of the manufacturing process, capturing crucial information such as batch details, materials used, equipment specifications, manufacturing steps, quality control tests, and operator activities. EBMRs are stored electronically within software solutions, enabling easy access, […]
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Electronic batch manufacturing records

What are electronic batch manufacturing records and how do you get started?

Electronic Batch Records (EBRs) and Electronic Batch Manufacturing Records (EBMRs) have revolutionized the manufacturing industry by digitizing paper-based batch records. These electronic systems provide comprehensive repositories of information, ensuring product quality, consistency, and compliance with regulations. In this blog post, we will explore what EBRs are, their benefits, and the steps involved in getting started with […]
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