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Corrective Action & Remediation Plans
Corrective Action/Remediation plans typically are an outcome of a Quality Audit or FDA audit finding (483 finding). However a firm may request such a plan as a result of documentation review etc. without actually conducting an audit. The plans will be organized according to risk and may include both corrective and preventive action recommendations, depending on available information. Plans may also include a work-break-down structure and resource requirements as requested. |
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