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
Tag Archives: qms
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,