TestPros, Inc.

Consultant

• 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.

Medical Records Management Testing & Validation Consultant