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HART COMPLIANCE SERVICES
Compliance does not have to be an expensive, time-consuming effort. Hart Compliance Services provides an efficient, risk-based approach to compliance, focusing on project-specific requirements to create and implement streamlined solutions customized for each client’s needs. We understand the compliance needs of large, established companies as well as those of startups or smaller organizations. We help our clients obtain the maximum level of quality compliance that their resources allow.
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Hart Compliance Services
Hart Compliance Services offers over 18 years of progressive experience with validation, compliance, and quality program development for the healthcare industry, including pharmaceutical, clinical trials, medical devices, and mobile medical apps.
The speed of our work is not challenged by any other company. We use constant collaboration and an open-door approach to both management and customer service. The strategic point of view is simple; provide the best service and the best solution at the best cost for each unique client.
HCS has been performing CSV tasks for nearly 20 years. We can help you validate new systems or perform validation remediation (“retro-validating” a system already in place) for any applicable system
HCS has an enormous library of templates and examples, offering a wide variety of customizable, sizable documentation solutions.
In the world of healthcare compliance, there is one rule above all else: “If it isn’t documented, it didn’t happen.” Polices and procedures must be approved and in place. Training must be established and tracked. A document management system or method must be utilized. Record retention must be defined. Technical solutions must be thoroughly documented and validated. Data must be secured. Access to facilities, documents, systems, data, and repositories must be monitored. Changes must be managed. Purchasing and vendor management must be handled with consistency.