Tag Archives: qms

Beyond Compliance: How a Training Module Optimizes Quality

Training Management in QMS

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

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

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

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

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,