ShoeBar Associates focuses on services related to software application and development for companies in the FDA-regulated area (medical devices and diagnostics, biotechnology, pharmaceutical, and vendors to any of these).

• Software Validation: Project evaluation, project planning, document preparation, test development and testing, and reporting.
  
  
• Part 11 Evaluation: Assessment of systems and/or processes, and improvement suggestions, for complying with the Electronic Records and Signatures regulation.
  
  
• Software Quality Systems: Process evaluation, compliance suggestions, and assistance in developing the needed SOPs.
  
  
• Auditing: Vendor auditing or independent auditing of the client’s software validation or software-related processes.
  
  
• Training: Targeted, on-site employee training on software validation, electronic records and signatures, and quality processes for software.
  
  
• Regulatory Consulting: Level of concern evaluation, tracing of development documentation to regulatory guidances and international standards.

All services are scaled to the client’s business area, size, and employee background.