This webinar explores how the life sciences industry is navigating complex supply chain challenges driven by evolving regulations, rapid technological advancements, and shifting healthcare ...

The FDA’s Final CSA Guidance represents a significant step in modernizing validation across the industry. While it brings clarity, many questions remain about interpretation, practical application, ...

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 ...

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 ...

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 ...

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 ...

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, ...

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, ...

Companies in the life sciences, food, and cosmetics industries are all too aware of how fickle the market is, how dynamic their studies and those under investigation are, as well as their timelines ...

There may be some misunderstanding surrounding FDA 21 CFR Part 11 when it comes to regulatory compliance for manufacturers of medical devices. We have discovered a major pitfall here: Many businesses ...