Understand the CSA Risk-based approach, when to use FMEA Vs CSA Risk assessment. Watch the webinar.

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 ...

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Most data integrity findings trace back to the same root cause: no systematic program. Not bad intent — missing infrastructure. Compliance Group builds the data integrity programs, procedures, and ...

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 ...

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 ...

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 ...

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 ...

What working with CG Looks Like“CG’s membership in the FDA Case for Quality CSV Team enabled trust and allowed for early adoption of new guidance.” Our team includes regulatory experts and validation ...

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 ...

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 ...

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 ...