Log Sheet SOP-24.1: Quarterly Quality Metrics is a structured, GMP-compliant log sheet used to document and evaluate key quality performance indicators on a quarterly basis. It supports objective monitoring of quality trends and provides documented input for management oversight and the annual Quality Management Review (QMR).
The log sheet is pre-formatted and ready to use, requiring only company- and period-specific information.
Designed to complement SOP-24: Quality Metrics, the template captures essential data such as changes, deviations, OOS results, rejected batches, CAPA timeliness, and repeated quality issues. It also includes a dedicated section for the Quality Manager’s assessment and decisions.
Includes:
• Quarterly period and review details
• Quality metrics categories and result fields
• Tracking of deviations, OOS, rejected batches, and CAPAs
• Timeliness indicators for corrective actions
• Quality Manager evaluation and decision section
• Signature and date fields for compliance documentation
Why it matters:
Regulators expect companies to actively track and evaluate quality performance. This log sheet provides clear, structured evidence of quality monitoring and management oversight, supporting inspection readiness and continuous improvement.
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Artikelnummer: SINGLE-SOP-24.1
189,00€Preis
exkl. MwSt.
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