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Risk Management-Audits

Risk Management has been scrutinized more and more by the agencies over the past several years. Many warning letters and 483 notices have included the work “risk” in their content. In addition, Risk based approaches, if implemented correctly, generally reduce overall costs and process times for things such as validation, audits, and assessments.

USDM has the knowledge and experience to work with companies to initiate a Risk Based Methodology, or assess the current process of risk. Some of our SME’s have spoken worldwide on this subject.

As an example for Failure Mode Effects Analytical audits, USDM can help you use root cause deductive logic to identify mechanism of potential failure mode and probability to reduce and or mitigate its effect on your business to keep it running and lessen regulatory exposure.

Other examples include: 

  • Risk Analysis for Approved Vendor Supplier Lists
  • Failure Mode Effects Analytical assessment (FMEA)
  • GMP Risk Detection-Risk Avoidance