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Articles about quality systems, manufacturing records, responsible product use and business operations.

Building a Practical CAPA Process

A useful CAPA process starts with clear problem definition, evidence-based root cause analysis, risk assessment, specific actions, assigned owners, realistic due dates and effectiveness […]

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How to Create a Controlled SOP System

A controlled SOP system uses approved templates, unique document numbers, revision tracking, defined responsibilities, training records and controlled distribution. Start with a master document […]

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