Risk Management Services

Improve Quality Assurance, GxP Compliance and Validation outcomes through effective Risk Management Strategies

Regulatory agencies have embraced the application of risk management across cGMP compliance, quality assurance, validation, product design/ development and computerised systems. Companies are now expected to justify their compliance position based on risk based strategies and management.

SeerPharma risk management services focus on assessing and improving the effectiveness of quality assurance, optimising GxP and validation activities and adding real value to compliance programs. Our clients leverage vital resources, work on the right issues and optimise compliance budgets.

• Corporate risk management strategies programs and assessments. ICH Q9 is now included in cGMPs in EU and FDA
• Implement predictive, not reactive, risk management practices
• Signifi cantly reduce time and costs in validation programs using ASTM E2500 approach
• Ensure your QA programs add real value – work on the right issues
• Conduct gap analysis to identify and mitigate real compliance risk
• Use risk management as a strategic planning and control tool
• Qualify CAPAs and Deviations using risk assessment
• Track risk based mitigation strategies within a CAPA system

Click here to download SeerPharma Risk Management Services.pdf

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