FDA Compliance

In the highly regulated world of life sciences, data integrity isn’t optional; it’s essential. The ALCOA principles—attributable, legible, contemporaneous, original, and accurate—provide a foundational framework for ensuring data are reliable and trustworthy.

With the rise of…

Cybersecurity has become increasingly critical in the digital age as organizations across all sectors face growing threats from cybercriminals.

Imagine that hackers breached a small healthcare practice through “phishing”—sending a scam email and gaining access to sensitive patient…

Before the ICH Harmonized Tripartite Guideline Q9—“Quality risk management”—was introduced in 2005, the pharmaceutical industry was evolving but lacked a structured, scientific, and systematic approach. Various stakeholders, including the industry, regulators, and patient rights groups,…

With its roots in compassion and humanity, the healthcare sector might seem an unlikely place for artificial intelligence (AI) to play a big role. Yet as we look deeper into the complex processes that build our medical systems, we uncover a multitude of ways that AI could revolutionize patient…

The U.S. Food and Drug Administration (FDA) is the country’s chief agency for regulating the manufacture, marketing, and distribution of critical consumer goods including food, cosmetics, medical devices, biological products, and pharmaceuticals. The FDA provides direct oversight of the…

This year, the Medical Device Innovation Consortium held an Excellence in Quality Summit where it was promised that participants would receive a “unique opportunity to learn adoptable cutting-edge practices to maximize the impact of investing in quality across [their] total product life cycle…