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 ...

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 ...

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 ...

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 ...

Quality Records and Documents – Non-Conformances (NC), Corrective Actions and Preventive Actions (CAPA), Change Requests (CR), Bill of material (BOM), Complaints, SOPs, Work Instructions, ...

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 ...

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 ...

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 ...

Title 21 CFR Part 11 is the portion of Code of Federal Regulations that provides standards determined by the Food and Drug Administration (FDA) on electronic records and electronic signatures. With ...

Bird-brained. Has anyone ever been called that? It’s definitely not a compliment. However, a bird’s eye view is considered good, like being in the crow’s nest or traveling straight as the crow flies.