The U.S. Food and Drug Administration’s inspections and subsequent actions all come down to product quality. Quality system failures result in noncompliances that FDA inspectors target during their inspections. If there is any doubt that a manufacturer’s product is safe and effective, it is the agency’s responsibility to investigate issues, and the manufacturer’s responsibility to address them.

Below are key areas where manufacturers can apply eQMS automation to directly impact areas of regulatory compliance most cited in FDA inspections, Form 483, and warning letters.

Document management and control

Failure to establish and follow written processes consistently appears in many FDA Form 483 observations and warning letters issued to manufacturers. This underscores the prevalence of poor documentation in manufacturing today, a problem that can lead to recalls, fines, and reputational impacts.

Document management and control is essential. Managing and controlling large volumes of documents includes SOPs, training records, and quality manuals.

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