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
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.
Over the past decade, “Digital Transformation” has become one of the most widely used—and often misused—terms in business. It has graced keynote speeches, investor pitch decks, consulting proposals, and corporate mission statements. And while it’s often touted as the cure-all for operational inefficiency, competitive stagnation, and regulatory complexity, the term itself has lost much of
Pharmaceutical companies operate in one of the most heavily regulated industries in the world. From early product development to post-market surveillance, each step demands strict compliance with a complex web of global regulations. A Regulatory Management System (RMS) helps make that compliance manageable. Far more than a digital filing cabinet, an RMS is a centralized,
For pharma and medical device companies, “validation” of automated systems is typically expensive and cumbersome. And it’s a process that delays the implementation of new systems and processes. Regulatory requirements require that organizations be able to demonstrate that their software systems are fit for their intended use, operate as expected, and meet regulatory standards. Traditionally,
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
System integration has been one of the most time-consuming, expensive, and risky aspects of implementing software solutions in pharmaceutical companies for years. Whether connecting a Quality Management System (QMS) to an Enterprise Resource Planning (ERP) platform or linking different parts of a Manufacturing system, the process has traditionally relied on complex, custom-built back-end integrations. These
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
For growing life sciences companies, investing in technology is a critical key to unlocking rapid growth. But the question of where to start can be perplexing. One great choice is to address the need to plan and manage employee training activities. Selecting the right Training Management System (TMS) can immediately address regulatory requirements while improving
The digital transformation journey is a critical one for any growing pharmaceutical company because it can unlock new avenues of growth. However, when faced with the daunting task of shifting from manual systems to automated ones, many companies struggle with knowing where to begin. While it is true that the journey can feel overwhelming, there’s