Risk assessment workbook (FMEA)
FMEA risk analysis tool.
1 300 Skr
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Purpose:
Provides a structured workbook to perform and document risk assessments using Failure Modes and Effects Analysis (FMEA) methodology to support GMP risk-based decision-making.
Regulatory Alignment:
Aligned with EU GMP expectations for quality risk management and consistent with ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System).
Included Files:
• FMEA-based risk assessment workbook
• Risk scoring and prioritisation tables
• Guidance fields to support consistent risk evaluation
Format:
Microsoft Excel (fully editable)
Intended Users:
Pharmaceutical manufacturers, quality assurance teams, technical, manufacturing, and validation personnel involved in GMP risk assessment activities.