This webinar explores how the life sciences industry is navigating complex supply chain challenges driven by evolving regulations, rapid technological advancements, and shifting healthcare ...

The FDA’s Final CSA Guidance represents a significant step in modernizing validation across the industry. While it brings clarity, many questions remain about interpretation, practical application, ...

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.

From CSA to digital transformation, our experts turn compliance into a competitive advantage. OCM bridges the gap between innovation and adoption—ensuring your workforce is ready when change occurs.

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 ...

Change management is when an organization creates a step-by-step protocol to manage and implement modifications to products and processes. A change management plan is a protocol that implements and ...

Modern technology is always crucial to the advancement of the healthcare sector and the quality of healthcare provided to patients. Technology enables medicine to change, adapt, and advance, from the ...

In the life sciences industries, documentation plays a crucial role in proving the product’s effectiveness and safety. Furthermore, it discusses the processes and practice’s dependability, ...