Being human, we make mistakes. Using paper increases those odds. We’re writing /typing/-swiping in 2022. However, many companies aren’t moving their documents along digitally yet. Why? If we have an ...

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Industry is being driven to constantly improve their processes and systems for designing, manufacturing, testing, and servicing their products. Industry 4.0 is about enabling cyber-physical systems ...

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 ...

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 ...

Version control is required for documents involving processes, procedures, and best practices that undergo revisions and redrafting to maintain regulatory guidelines and compliance. Throughout the ...

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 ...

Change Management, as you may know, involves the process and methodology focused on the people side of change. In simple terms, it’s about helping people succeed through change, enabling your ...

As AI adoption accelerates across life sciences, organizations face a critical challenge: determining when AI becomes relevant to GxP compliance. But is asking whether an AI solution is GxP or non-GxP ...

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 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 ...