Documenting Equipment Qualification in Pharma: Templates, Records & Audit Readiness

Documenting Equipment Qualification in Pharma: Templates, Records & Audit Readiness Documenting Equipment Qualification in Pharma: Templates, Records & Audit Readiness In the pharmaceutical industry, equipment qualification is not just about installation, operation, or performance testing. What distinguishes a compliant, audit-ready process from an inadequate one is documentation. Regulatory agencies such as the FDA, EMA, and WHO emphasize that “if it’s not documented, it didn’t happen.” This principle underscores the criticality of detailed, accurate, and controlled documentation throughout the equipment qualification lifecycle. This article provides QA, validation, and regulatory teams with an actionable framework to generate and manage qualification documentation from…

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