For young pharmaceutical companies, the prospect of an audit — whether internal or from regulators — can be intimidating. And it is not just the worries about the audit results; it is the large amount of preparation needed to get ready. Pulling together the proper documents, double-checking training records, and making sure every deviation is
Tag Archives: document management
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
In a recent blog, we discussed the growth that Latin America’s pharmaceutical market has experienced in recent years and said the trajectory seems promising for the future. Readers responded by asking why we feel the market is so promising, so here is a summary of the top five reasons we believe the market will continue
For most small and mid-size pharma companies, risk reduction is the overarching reason for investing in automated quality management and training management systems. That makes sense because quality and training management systems help ensure adherence to regulatory requirements, and any failure to comply with those standards may result in product delays, fines, and reputation risks.
Dubai, UAE – November 10, 2023 – Scigeniq, a Dubai-based provider of cutting-edge quality and regulatory solutions for the pharmaceutical industry, is pleased to announce that Amman Pharmaceutical Industries (Amman Pharma) in Amman, Jordan, is implementing Scigeniq’s Regulatory and Document Management systems. “With our focus on providing quality and regulatory solutions for leading pharma companies
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
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.