Medical Records Management Testing & Validation Consultant

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🕒 May 27

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TestPros, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1988

📋 Compliance

🔒 Cybersecurity

Compliance • Cybersecurity • Consulting

TestPros, Inc. is an established company founded in 1988, providing independent reviews, testing, and consulting services to meet the information technology needs of both federal and commercial clients. They specialize in compliance, cybersecurity, accessibility, and software testing, offering services such as digital accessibility solutions, verification and validation, IT assessments, and compliance consulting. TestPros is trusted by a diverse clientele, serving sectors like healthcare, government, and finance, ensuring their services meet rigorous industry standards. They have secured numerous government contracts and are dedicated to enhancing quality assurance and operational excellence for their clients.

📋 Description

• Support hands-on testing and compliance validation of a medical records management and electronic document management application operating within a regulated healthcare environment. • Perform functional, security, compliance, privacy, and data integrity testing of systems managing sensitive healthcare and electronic records. • Execute compliance validation activities related to HIPAA, FDA 21 CFR Part 11, ISO 16175-1, and ISO 14641 requirements. • Review system functionality related to electronic records management, electronic signatures, audit trails, access controls, and user permissions. • Develop and execute test plans, test cases, validation scripts, traceability matrices, and compliance validation documentation. • Validate data integrity, record authenticity, retention, and system security controls. • Document findings, risks, gaps, and recommendations.

🎯 Requirements

• Experience testing or validating medical records systems • Experience testing or validating electronic document management systems (EDMS) • Experience testing or validating Electronic health record (EHR/EMR) systems • Hands-on experience with software testing and validation in regulated healthcare, pharmaceutical, biotech, medical device, laboratory, or records management environments • Strong understanding of HIPAA Privacy Rule • Strong understanding of HIPAA Security Rule • Familiarity with FDA 21 CFR Part 11 • Experience validating electronic records • Experience validating electronic signatures • Experience validating audit trails • Experience validating access controls • Experience validating security safeguards • Experience validating data integrity controls • Ability to analyze regulatory requirements and translate them into testable validation criteria

🏖️ Benefits

• Equal Opportunity Employer