Batch Records

As a biologics manufacturer, you’re likely aware of the complexities and nuances of working with living organisms. Electronic Batch Recording (eBMR) can help streamline your operations and ensure compliance. However, biologics manufacturing poses unique challenges.  Unique Considerations for Biologics  Biologics manufacturing requires special consideration due to the nature of living organisms. These include:   Cell Line […]

Imagine a scenario where a batch of life-saving medication is stuck in customs due to incomplete documentation. The delay not only affects the patients waiting for the medication but also impacts the entire supply chain. This is just one example of how poor BMR documentation can have far-reaching consequences. Let’s explore the impact of poor […]

Change is inevitable, but when it comes to Batch Manufacturing Records (BMRs), it’s crucial to manage those changes effectively. Think of BMR change control like updating a recipe book. You need to ensure that every change is documented, approved, and communicated to the right people. Let’s dive into the best practices for BMR change control […]

As a pharma professional, you know how important it is to get your Batch Manufacturing Records (BMRs) right. But manual data entry can be a real pain point, leading to errors and delays. What if you could reduce those errors and make your life easier? Let’s explore how automated data capture technologies can help.  The […]

As a pharma manufacturer, you’re likely familiar with the importance of Batch Manufacturing Records (BMRs) in ensuring product quality and compliance. But have you ever stopped to think about the critical connection between BMRs and batch release? In this article, we’ll explore the relationship between these two essential processes and why getting it right matters.  […]

If you’re part of India’s pharmaceutical manufacturing world, it’s crucial that you align your practices with CDSCO guidelines for BMR and eBMR. The Central Drugs Standard Control Organization (CDSCO) plays a key role in regulating how batch records are created, maintained, and audited across the country.  Let’s break it down so you can understand what’s […]

If you’re working in pharmaceutical manufacturing, understanding the FDA guidelines for electronic batch records (eBMR) is no longer optional — it’s essential. In 2025, the FDA is putting more emphasis on data integrity, system validation, and real-time traceability. So, if you’re using or planning to switch to eBMR systems, here’s what you need to keep […]

A vaccine manufacturer once faced a nightmare: a critical batch failed because of inconsistent mixing times. The culprit? Disconnected systems and manual errors. This costly mistake could have been avoided with ISA 88 and ISA 95 in pharma—the twin standards revolutionizing batch control.  What Are ISA 88 & ISA 95?  These International Society of Automation […]

The pharmaceutical industry is undergoing a digital transformation, with companies moving from traditional paper-based systems to automated solutions. At the heart of this shift are Electronic Batch Manufacturing Records (eBMR) and Electronic Quality Management Systems (eQMS), two powerful tools that ensure compliance, enhance efficiency, and maintain a quality-first approach in manufacturing.  Integrating these systems allows […]

Struggling with Pharma Compliance & Efficiency? Here’s How ProcessXE’s® eBMR Software Can Help!  Pharmaceutical manufacturing is a complex process that requires precision, compliance, and efficiency. However, traditional batch record management methods often lead to inefficiencies, compliance risks, and high operational costs. If you’re still relying on paper-based or outdated systems, you’re likely facing challenges such […]