batch records

Role of Batch Records at Process XE®

Precision, efficiency, and compliance are grave in the fast changing pharmaceutical, biotechnology, and chemical sectors. The hardworking administration of batch records is a key pillar supporting these aims. We investigate the relevance of batch records in Process XE® operations, giving light on their critical role in ensuring quality, safety, and regulatory compliance. Understanding Batch Records […]
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Comparing Master Batch Records with Electronic Batch Records

Comparing Master Batch Records with Electronic Batch Records

In the pharmaceutical manufacturing sector, Master Batch Record (MBR) and Electronic Batch Records (EBR) are two crucial documents that are required to preserve quality, efficiency, and compliance. The industry is getting closer to digital transformation, which has sparked a debate about the optimal strategy. In this comparative analysis, we examine the distinctions between MBRs and […]
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Why is Batch Record Software required_ Best Batch Record Software for Mid-size Pharma Manufacturing Companies!

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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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 Structure of a Perfect Batch Record

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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Electronic Batch Recording Software-Salient features

Electronic Batch Recording Software-Salient features

Pharmaceutical industry is one of the industry needs to comply with stringent regulatory and quality guidelines to reassure the superior quality of medicines they are delivering for the wellbeing of human health. Effective management of batch recording documents like Master Production Control Record (MPCR) and Batch Production Control Record (BPCR) is very important part of […]
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Why batch manufacturing records are so important according to GMP

Why batch manufacturing records are so important according to GMP?

Batch Records According to good manufacturing practices (GMP) your each process should be documented properly to establish evidence that your process, operated within pre-established parameters to prove that the produced drug and dietary product meeting its pre-determined specifications and quality attributes. Before establishing the importance of creating and maintaining batch manufacturing records, let’s understand what […]
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