Jesse MSOPM

Proprietor at Hart Compliance Services - Indianapolis, IN, US

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Hart Compliance Services
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Hart Compliance Services

Indianapolis, IN, US • 5 - 9 Employees
Non-Profit

Providing compliance services for IT companies that are beginning to sell software as a medical device. Have you been audited? Asked to be Part 11 or 820 compliant? We have been working on projects that include software as a medical device. Need help? Please contact us. Realistic rates and a small team to help meet your needs. We specialize in creating IT Quality Management systems. Specializing in computer system validation and Part 11. Let us be your company's compliance life preserver! Compliance does not have to be an expensive, time-consuming effort. Hart Consulting's compliance services provide an intelligent, risk-based approach to validation, focusing on project-specific requirements. Because each project is unique, we create and implement efficient, stream-lined plans specifically customized for each client's needs. The most successful projects are managed by one company with cooperation from the client. Instead of outdated, inefficient staff augmentation, Hart Consulting offers a project-based approach.

Software as a Medical Device IT Quality Management 21 CFR Part 11 Gap Assessments Risk Assessments Computer System Validation Pharmaceutical Biotech Medical Devices HIPAA Project Management PMP s IT Compliance Quality Programs Project Management Methodologies Risked Based Approach
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