ShoeBar Associates Information

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. * Agile Transition: Training and assistance with implementing Agile methods for regulated medical software development (through special collaboration with Lean-Agile Partners) * 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.