EBR and QMS Integration: Unlocking the Power of Detective Work in Pharmaceutical Manufacturing

EBR and QMS as a detective

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,

Electronic Batch Records: A Crucial Link in Your Quality Management System

EBR Webinar Summary

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

The Key Quality Metrics You Need to Track in Your Pharma Business

Quality Metrics

The goal of quality management in pharma is to ensure that products are manufactured and tested consistently according to the regulations and guidelines set by the regulatory authorities. A quality management system with robust reporting of quality metrics helps pharma companies track and manage quality processes to ensure they are compliant.   But what kind

Did You Say You’re Using an ERP System for Quality Management?

ERP is not a QMS

The first time I heard someone say they were considering using their ERP platform as their quality management system (QMS), I was pretty sure I had misheard them. However, by the third time I heard it, I realized my hearing was fine. I think it’s important to talk about this because leveraging an ERP platform

4 Step Action Plan for Digital Transformation in Mid-Sized Pharma

digital transformation action plan

Digital Transformation is a very broad concept, but at its core it means leveraging computers and other digital technologies to fundamentally change the way a business operates. A simple example…Uber transformed the taxi industry by combining a mobile application for users, a digital dispatching system and a digital payments model.  For Pharma companies, digital transformation

Transforming Quality Management in Pharma: The Seven Core QMS Processes

QMS core processes

In the highly regulated pharmaceutical industry, effective quality management is crucial for ensuring that products meet safety and efficacy requirements. The right combination of processes, procedures, and policies helps pharma companies manage and improve product quality from development to distribution. However, quality initiatives can fail to deliver results if, as is often the case, quality

Regulatory Compliance Starts with Effective Document Management

Effective Document management in Pharma

Document management is an essential function for pharmaceutical companies. It allows them to efficiently store, organize, and retrieve important documents related to drug development, clinical trials, manufacturing, distribution, and other business critical information. Failure to effectively manage these documents can result in serious consequences such as fines, delays in product launch, and even legal action.

5 Essential Features in a Regulatory Management System

RMS Life Sciences

If you are in the process of researching and selecting a regulatory management system RMS), it’s essential to understand what the key capabilities are (you can read about these here). But equally important is identifying if the RMS you are looking at includes five essential features. What are those features? Let’s take a look.   1.

What is a Regulatory Management System?

What is a regulatory management system

Regulatory compliance is complex and time-consuming for life sciences organizations. But there are ways to make it easier with the assistance of technology. In a recent webinar, MarieLouise Abi Hanna, RMS Product Lead, provided insights and guidance on regulatory management systems (RMS) and how they help pharmaceutical, medical device, and biotech companies build and maintain

Meet My New Superhero: The Quality Manager

Quality Manager - Super Hero

I recently met with a Scigeniq customer – I will call her Tara – and she made a profound impression on me. She personified everything I find so amazing about the people who manage quality in pharma companies. Tara is the quality manager for a pharma company. So, of course, she is responsible for designing,