Principal Consultant: Brian Shoemaker, Ph.D.

• More than thirteen years’ experience with software quality and validation in the FDA-regulated industry.
  
  
• Knowledgeable in diverse application areas, including automated in vitro diagnostics, clinical trial data management, clinical safety data, ERP and shop floor automation, change order management, and electronic document management.
  
  
• Well versed in practical application of FDA and ISO requirements for software life cycle documentation, validation, and risk management.
  
  
• Adept at unraveling issues around electronic records and signatures (21 CFR Part 11).
  
  
• Diverse clientele, including manufacturers, software developers, medical device startups, and pharmaceutical multinationals.

Mission Statement

ShoeBar Associates is committed to helping our clients establish software quality and control, to achieve regulatory compliance, world-class product reliability, and unquestioned patient and user safety.