When I talk about quality software with leaders of growing life sciences, we talk an awfully lot about compliance. That makes sense because meeting regulatory requirements is a fundamental requirement for every company that manufactures pharmaceuticals, devices, or other highly regulated products. However, it is just as important to discuss another topic that is equally
Category Archives: quality management
In younger life sciences companies, things move very fast. Sometimes, there is even a sense of chaos as new products are brought to market and new manufacturing processes are brought online. It’s an exciting phase of the business, with mad scrambles to meet milestones, and a kind of creative entropy that energizes the entire company.
SANTA CLARA, Calif., April 1, 2025—ValGenesis, Inc. ValGenesis Inc., a leading provider of enterprise validation lifecycle management solutions, announced that Scigeniq has successfully implemented ValGenesis VLMS 5.0, modernizing its qualification and validation processes. As a life sciences technology and consulting firm specializing in compliance solutions, Scigeniq adopted VLMS to streamline internal processes and strengthen its
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
The pharmaceutical industry is undergoing a significant shift, driven by the need for increased efficiency, stricter regulatory compliance, and the rise of Industry 4.0. Abdullah Othman, Chief Product and Quality Officer at Scigeniq, and Aghiles Mitiche, Sr.Manager of Operational Excellence at Julphar, recently attended Forum A3P Middle East and conducted a workshop highlighting electronic Quality
The pharmaceutical landscape in the Middle East and North Africa (MENA) region is undergoing a rapid transformation, and Saudi Arabia is firmly at its helm. With its proactive regulatory framework, ambitious Vision 2030 objectives, and substantial investment in local production, the Kingdom is shaping the future of the region’s pharma industry. Smart pharmaceutical companies and
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
Almost every argument about why investments in automated Quality Management Systems (QMS) are justified centers on compliance. And that makes perfect sense because failure to meet the requirements of regulatory authorities would be catastrophic for any pharma company. But for just a moment—stick with me here—imagine a world without regulatory authorities, no FDA or EMA,
Dubai, UAE October 7, 2024: Scigeniq is pleased to announce it has evolved its partnership with ValGenesis from Service Partner to Excellence Partner, allowing it to take on a more active role in the sales, configuration, and implementation of ValGenesis’s flagship product, Validation Life Cycle Management Solution (“VLMS”). Scigeniq provides unique solutions that guide customers’