Join our upcoming Complementary Webinar on Integrated Compliance – Synergy between GxP and Other Regulatory Requirements in association with KENX. Immerse yourself in an engaging discussion featuring ...

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 ...

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 ...

For health and life sciences organizations, compliance with regulatory requirements is non-negotiable. Historically, Computer Systems Validation (CSV) has been the focus of QA and compliance ...

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 ...

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 ...

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 ...

FDA (Food and Drug Administration) issued a draft guidance to offer recommendations on Computer Software Assurance (CSA) for automated data processing systems that are used as a part of medical device ...

Packaging and sterilization validations are a critical step in the development and manufacturing of medical devices, as they ensure patient safety, regulatory compliance, product quality, and the ...

ISO 13485:2016 is an international standard for medical device manufacturers and providers of quality management systems. ISO 13485:2016 is not a law or regulation and is voluntary, while FDA 21 CFR ...