Organizational performance depends on established operational systems, and successful performance depends on systems that are synergistic and function together smoothly. At Keathley and Company, we view the organization as a whole with multiple interdependent parts, and we focus on ensuring those parts work together as effectively as possible.

Case Studies

Quality Management System deployment, Drug Development Real World Experience (RWE) Industry

• Conducted gap analysis on QMS compliance for innovative drug development company managing RWE studies 
• Established QMS integration project plan after meeting with key stakeholders and reviewing QMS environment

Quality Management System deployment, Medical Device Software Industry

• Created QMS for innovative entrepreneurial company that had matured to a point where standardization was needed for efficiencies and regulatory compliance was required by primary vendor partner
• Established project plan after meeting with key stakeholders and conducting initial gap analysis
• Executed plan to satisfaction of company management and vendor partner
• Continued to maintain and improve system
• Multiple vendor partner and regulatory audits completed with minor or no findings

ISO 9001 Quality Management System implementation, Clinical Research Industry

• Co-chaired ISO9001 deployment project for international clinical research organization that resulted in successful ISO registration
• Standardized processes throughout offices in multiple countries and ensured alignment and integration across all facets of clinical trial services, including:
• Clinical study start-up and documentation
• Trial execution, monitoring, and clinical data collection
• Data management
• Statistical analysis and reporting
• Safety monitoring
• Oversaw updates of company’s QMS processes to consistent format, ensured key process metrics established for all processes, developed reporting system for monitoring process performance 

Performance Feedback Reporting, Baldrige Criteria

• Examiner for Baldrige Performance Excellence Program (sponsored by National Institutes for Standards and Technology, Department of Commerce)
  
• Participated on multiple Baldrige teams at Virginia state and national level; served as Examiner, Team Leader, Trainer, and Editor
  
• Evaluated organization applications against Baldrige Performance Excellence criteria
  
• Developed feedback reports identifying performance strengths and opportunities
  
• Participated on multiple site visits and feedback visits
  
• Reviewed applications from a variety of sectors, including healthcare, manufacturing, government/non-profit, small business, and education
  

Quality Control System deployment, Biopharmaceutical Manufacturing

• Upgraded and enhanced quality control system for manufacturer of bulk tissue culture products sold to pharmaceutical companies, including:
• Development of standardized quality control procedures
• Refinement of processes for key tests, such as endotoxin detection
• Training of quality control staff
• System met FDA GMP requirements, as evidenced by successful FDA audit, and was developed under Corning Total Quality Management program