Join us for an insightful webcast exploring the transition from traditional Computer System Validation (CSV) to the modern, risk-based Computer Software Assurance (CSA) approach. This session will ...

The life sciences industry faces complex supply chain challenges that stem from regulatory and compliance shifts, fast moving technological advancements, and evolving healthcare expectations.

Explore the future of Computer System Validation (CSV) and Computer Software Assurance (CSA) at the KENX CSV & CSA University 2025, Hybrid Conference, a two-day program designed for professionals in ...

The different processes involving multiple roles like supplier, production, manufacturer, and pieces of equipment for designing or marketing a product will inevitably invite some non-conformance ...

In the realm of Computer System Validation (CSV), risk assessment stands as a cornerstone in ensuring the safety, efficacy, and compliance of software systems, particularly in regulated industries ...

As the FDA and other regulatory bodies raise the bar for software validation in healthcare and life sciences, computer software assurance (CSA) activities are becoming increasingly critical to ...

When a company is issued an FDA 482 Notice of Inspection and FDA 483 Warning Letter, it must prepare and be ready for the long adventure it will have to take with the FDA. Receiving an FDA 482 means ...

What exactly is Compliance documentation and how do you know if you are creating clear, concise, accurate content? In the life sciences field compliance documentation is crucial for meeting regulatory ...

Join us at 2024 Medical Device Innovation Consortium (MDIC) Quality Summit, Where you will learn about adoptable cutting-edge practices to maximize the impact of investing in quality across your total ...

The Sarbanes-Oxley Act (SOX) is a U.S. law that was passed in 2002 to protect investors by preventing fraudulent accounting and financial practices at publicly traded companies. The law's purpose is ...

In this session, we will delve into Stage 3 of OCM: Adoption examining its definition, the concept of acceptance, strategies for fostering responsiveness, and insights into overcoming resistance.

ISO 13485:2016 is an international standard for medical device manufacturers and providers of quality management systems. ISO 13485:2016 is not a law or regulation and is voluntary, while FDA 21 CFR ...