For growing life sciences companies, investing in technology is a critical key to unlocking rapid growth. But the question of where to start can be perplexing. One great choice is to address the need to plan and manage employee training activities. Selecting the right Training Management System (TMS) can immediately address regulatory requirements while improving
Tag Archives: qms
For young pharma companies, the focus is typically on research, securing funding, and pushing products through the development pipeline. However, the need for a more structured, automated Quality Management System (QMS) becomes critical as operations grow. At that point, moving from manual processes to an automated QMS is not just a “nice to have”—it is
It is just a guess, but over the last 25 years, I have probably helped about 100 companies transition from paper-based systems to automated systems for managing documents, quality processes, and training activities. One thing I have learned is that for some companies, the transition is fast and relatively painless, and for others, it can
Implementing a digital Quality Management System (QMS) is a transformative step for growing pharmaceutical companies. A QMS enhances operational efficiency, ensures regulatory compliance, and improves product quality. One significant challenge, however, can be that the path to a fully operational QMS can be daunting, particularly when considering the range and complexity of the processes involved.
Compliance with industry regulations is often the focal point in discussions about quality management systems (QMS). That’s not surprising since adherence to standards and regulations is an existential issue for any pharma company. However, another element of QMS systems that deserves more attention is how a complete QMS can drive teams to very high levels
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,
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 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
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
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,