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.