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 ...

CSA draft guidance 2022 is Finally here – Join Compliance Group, FDA, and FICSA Team members for a series of webinars to clarify the Application of CSA in your organization ...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

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 ...

The significance of FDA Computer Software Assurance (CSA) cannot be overstated when it comes to laboratory systems in today's technological era. Embracing the CSA methodology is crucial as it promotes ...

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 development of new medical devices or any new project brings a new set of risks. A Risk Management Plan (RMP) must be developed at the start of the Risk Management Process for a new project or ...

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 ...

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 ...

As the pace of digital transformation and automation accelerates, the need for a robust and lean risk assessment methodology for software is becoming more and more critical in the life sciences ...