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 ...

As FDA’s Quality Management System Regulation (QMSR) takes effect on February 2, 2026, medical device organizations face the most significant shift in quality and compliance expectations in decades.

Join us in person or virtually at the upcoming KENX Validation University and Pharmaceutical Engineering Summit 2026, taking place March 19–20, 2026 in Philadelphia, PA. Save $400 with early bird code ...

As the English saying goes, "Potato, Potato" doesn't translate well in the written form. Still, it's saying the same vegetable but with a different pronunciation, meaning it doesn't matter how you say ...

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 ...

Corrective And Preventive Action (CAPA) is often discussed as it is an alarming issue for the life sciences industry. Organizations consider its importance and try to deal with it better as CAPA's are ...

The US Food and Drug Administration (FDA) is responsible for protecting public health by ensuring medical devices' safety, efficacy, and quality. The agency has developed a rigorous medical device ...

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 ...

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 ...

Information flow is evident in the life sciences industry, resulting in more unstructured data. Therefore, quality data is vital for effective and compliant operations as the industry's regulations ...

Maintaining Data integrity for medical devices is still a challenge in the current healthcare industry. Data Integrity means that information is accurate and has not been altered in any way. Incorrect ...