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Risk Management Services

Risk Management Services

Managing risk is paramount for your organization’s quality program. Assessing risk allows you to tailor your qualification approach based on the criticality of your systems. This allows you to allocate your time and resources when and where you need them the most, consequently reducing cost and cycle time in achieving compliance. The regulations related to assessing and managing risk impact many areas and individuals of an organization including: quality assurance/quality control, validation, information technology, regulatory affairs, system owner, auditors, engineers, and project managers.

Our consultants will
  • Provide direction on how to make risk management work in your organization
  • Identify risks to assess the impact on schedule, costs, and quality
  • Assist you in preparing for the new FDA System-Based Inspection Program
  • Translate high-level theoretical concepts of Risk Management into practice
  • Transfer practical approaches and techniques to individuals for risk management
  • Assist you in benchmarking risk management efforts
  • Assist you in creating risk management templates that can be immediately and effectively implemented
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