About ShoeBar Associates
Principal Consultant: Brian Shoemaker, Ph.D.
- More than 20 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.
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.