In Chapter 4: Tracking What Matters – KPIs and Dashboards, we explored how visualizing workflow and defining the right KPIs helped us spot bottlenecks and align our teams around value delivery. With better visibility into our DevOps pipeline, we began to ask deeper questions-not just where the bottlenecks were, but why they were happening.
In our previous chapter, Designing for Testability: Breaking the Next Barrier, we explored how testability became a key focus after resolving initial bottlenecks in team setup and manual testing. That chapter marked a turning point in our DevOps transformation, as we shifted attention to deeper software design principles that enabled smoother, faster testing.
In our ongoing DevOps for the Win series, we’ve been documenting our DevOps transformation journey. In Chapter 1, we introduced the DevOps Triangle: Tools, Architecture, and People in Product Development, where we discussed the foundational elements that drive DevOps success.
The FDA's accelerated approval pathway has always balanced speed with rigorous evaluation.
In the second chapter of this series – DevOps for the Win, we explore the crucial initial steps of a DevOps transformation journey. The first steps in any transformation journey are often the hardest. In DevOps, identifying the right initial steps-ones that are both impactful and achievable-is key to driving meaningful progress.
Knowledge is valuable, but its real power lies in how we put it into action. At Freyr Digital, we were familiar with DevOps, its associated practices, and how it could transform our organization into a high-performing product development powerhouse-capable of delivering quality products and solutions to our life sciences customers. As we began our journey, our efforts laid a strong foundation, but to truly become a development powerhouse, we knew we needed to adopt a more strategic and adaptive approach.
USFDA Form 483, often known simply as "Form 483," is a critical document in the pharmaceutical and biotech sectors. Issued by the U.S. Food and Drug Administration (USFDA) after inspections, this form highlights observations regarding potential violations of the Federal Food, Drug, and Cosmetic Act. For companies regulated by the USFDA, receiving a Form 483 requires immediate attention and action. This article delves into what Form 483 is, and why it is issued?
We can all agree that the life sciences industry is ever evolving. But how was 2024 different, and what will set 2025 apart? The life sciences industry has always been defined by its ability to adapt, innovate, and evolve. But the rapid advancements in Artificial Intelligence (AI) and emerging technologies throughout 2024 have set the stage for a transformative era in regulatory affairs. As we move into 2025, the early adopters of these technologies are not just keeping pace—they're pulling ahead.
Imagine a world where every digital interface you interact with is tailor-made just for you—adapting dynamically to your needs, preferences, and context in real- time. Welcome to the world of Generative UI, a cutting-edge approach to user interface design redefining personalization and efficiency in digital experiences.
Regulatory audits are an unavoidable reality in the pharmaceutical and life sciences industries. Agencies like the FDA, EMA, and other local regulatory bodies meticulously review documentation, processes, and data integrity. A single overlooked document, inconsistency, or human error can lead to severe consequences such as delays, financial penalties, and product recalls. The critical question is: Are you truly prepared for your next regulatory audit?