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
Dubai, UAE – October 3, 2023: Scigeniq, a provider of advisory services and software applications, announces continued rapid growth in the second and third quarters of 2023, adding to its product portfolio and dramatically expanding its customer base in the MENA region as well as Brazil. In recent comments, Jawad Kamal, the CEO of
Quality and manufacturing managers know that a method for documenting and reviewing accurate batch records is the single most important element in a pharmaceutical manufacturing and quality process. That’s because, without accurate batch records, even a well-designed quality system will be vulnerable to audit findings and warning letters. After all, nobody wants to receive a
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,
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
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.