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We have direct experience with the science, engineering, and operations in FDA-regulated companies – we understand your business. |
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We stay informed on FDA and ISO expectations, and can guide your team to make sure those expectations are met. |
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We’ve been closely involved with implementing electronic records and signatures to satisfy FDA regulations. |
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We’ve designed and implemented software quality systems – SOPs and associated documents – multiple times, and have created outlines and templates to save you time. |
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Welcome to Our Site
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).
Our Services 
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Software Validation |
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Part 11 Evaluation |
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Software Quality Systems |
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Auditing |
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Training |
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Regulatory Consulting |
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Recent Projects
...more projects here
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Dental prosthetics company (through medical device consulting group): Assessed software quality and testing processes; planned complete project of developing software-related SOPs, user requirements, software design documentation, and software test procedures. Working directly with project team in Germany on all project deliverables.
Diagnostics firm: Assessed software validation and quality processes; assisted in developing system FMECA. Guided development of software-related quality procedures; provided initial draft of Quality Manual. Developed test plan and procedures for validating diagnostic image processing software. Assessments carried February-April 2006; validation ongoing, near completion.
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