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6 Common Reasons External Quality Audits Fail

In FDA and ISO environments, quality audits are a process of examination and substantiation that procedures, records, and activities are effectively aligned with desired objectives. The FDA and [...]


Root Cause Analysis Tools: Which Should You Use?

Root cause analysis is a common weak spot in manufacturing, causing numerous quality issues, product safety problems, and enforcement actions. For example, recent headlines over baby formula [...]


8 CAPA KPIs You Should Be Measuring Now

Corrective and preventive action (CAPA) is a core function in any quality management system (QMS) and critical to the Plan-Do-Check-Act process approach. Like any quality process, tracking CAPA [...]

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