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
Author Archives: Ken Lownie
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
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,
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 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
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,
Navigating the complex regulatory environment is a constant challenge in every country. Between evolving standards, stringent documentation requirements, and the need for timely submissions, keeping up can overwhelm even the most efficient teams. Nowhere is this more true than in Brazil, where ensuring compliance with ANVISA (Agência Nacional de Vigilância Sanitária) requires constant attention and