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 ...

In this session, participants learn some of the newer digital capabilities that enable simulation for designing out manufacturing defects, enforcement to error proof ...

These webinars describe “Computer Software Assurance” as a Risk-based approach to establish confidence in the automation used for production or quality systems and identify where additional rigor may ...

Learn from integral industry experts about the CSA Risk-Based Approach – We’ll discuss the good, the bad, and benefits gained from implementing CSA – Gain an intelligent understanding of how to ...

Since the release of the FDA draft on Computer Software Assurance (CSA), September 13th, 2023, many questions and concerns have been raised regarding the impact of the guidance on 21 CFR Part 11. The ...

CSA draft guidance 2022 is Finally here – Join Compliance Group, FDA, and FICSA Team members for a series of webinars to clarify the Application of CSA in your organization ...

This session will highlight into the evolving viewpoint on AI governance in MedTech. Learn how to align your strategies with current and upcoming regulatory expectations and prepare for regulatory ...

So, Quality Management System has produced a step-by-step process to help companies handle the CAPA process to get satisfactory results in adherence to ISO (International Standards Organization) FDA ...

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 ...

There may be some misunderstanding surrounding FDA 21 CFR Part 11 when it comes to regulatory compliance for manufacturers of medical devices. We have discovered a major pitfall here: Many businesses ...