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 ...

CSA draft guidance 2022 is Finally here – Join Compliance Group, FDA, and FICSA Team members for a series of webinars to clarify the Application of CSA in your organization ...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

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 ...

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 ...

Organizations must develop a written method to approve papers for sufficiency prior to issuance. Documents should be reviewed, updated as needed, and re-approved. Determine the changes and the current ...

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 ...

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 ...

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 ...

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, ...

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 ...

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 ...