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
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
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
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
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.
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.
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
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,
Last week a very impressive group of Pharma industry leaders gathered in Jordan to talk about “Digital Transformation” and the state of manufacturing and quality systems. At this remarkable event, sponsored by Scigeniq, a very clear thesis emerged. In essence, the shared belief among the speakers and participants is that Pharma companies in the Middle