Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quailty of the medicinal drug product across the product lifecycle.

The services we provide for the application of risk management tools in your industry include the following:

• Interpretation and Application of Quality Risk Management Guidelines (e.g. ICH Q9, ASTM, ISO) to your industry
• Documentation, review current interpretations and application of regulatory expectations (SOPs, guidelines, etc.)
• Training and Education
• Auditing/Inspection
• Risk identification and control (application of tools such as FMEA, FMECA, FTA, HAZOP, etc.)
• Periodic reviews to interpret and analyze monitoring data
• Change management and change control

Risk-Based Approach for Qualification

• Interpretation and Application of Quality Risk Management Guidelines (ASTM, ISO)
• Leverage testing from Commissioning (Enhanced Commissioning)
• Eliminate redundant paperwork during qualification
• Reduce test cases based on risk assessments
• Interpretation and Application of new standards based on Risk Based Approach
• Streamline practices and procedures
• Develop risk management exercises (e.g., FMEA)