ShoeBar Associates
Medical Equipment - Dedham, MA, US
ShoeBar Associates Employees
ShoeBar Associates Details
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.
ShoeBar Associates Technologies
Captcha
reCAPTCHA
Load Balancers
Apache
Fonts
Google Font API
Hosting
Blue Host
Online Video Platforms
YouTube