EVERSANA and ReproTech teamed up to develop an automated, web-accessible system to assist in the donor eligibility determination process.
This system is specifically designed to provide tissue organizations with the ability to fully automate the donor eligibility process in a way that is not only compliant with FDA 21 CFR 1271 but also speeds up eligibility determination and saves money.
Donor Eligibility Outsourcing Services
Donor eligibility determination has historically been one of the areas in the tissue industry to receive the most scrutiny by the FDA. There is a significant amount of data that can be difficult to collect and many changing variables go into the decision making process that ultimately determine the acceptance of a donor. Incorrect donor eligibility determinations can result in tremendous liability risk and loss of revenue.
That’s why based on inputs at each step of the donor eligibility process, the the DONOR ELIGIBILITY SYSTEM by EVERSANAutilizes validated logic to identify high-risk areas and non compliances in the donor information and helps you make the correct eligibility determination. Based on this determination, a compliant summary of records is created by the system according to the requirements of 21 CFR 1271.55(b).
We Help Clinics Be Operationally Excellent
The DONOR ELIGIBILITY SYSTEM by EVERSANA works to solve the following elements for any size clinic.
Zero Capital Cost
Services are provided on a subscription model to eliminate the need for software purchase
Experienced staff and pre-validated system reduce implementation timeline
Minimal impact to current operations
System training and support included
Expedited implementations available (≤4 weeks for most clinics)
Cloud system – Fully web-based
Full access to surveys, questionnaires, and records from anywhere with an internet connection
Assess and determine donor eligibility from anywhere with an internet connection
No need to manage and store documents and records manually
Control – Permission Based Control
Allow users access to records and responsibilities based on role
HIPAA compliant system and trained staff
Hassle-Free Licensing & Resources
Unlimited Licenses provided with subscription
Staffing – Dedicated EVERSANA resources
Systems administered by EVERSANA resources
Quality Assurance Support (As requested QA support during audits for any system inquiries)
Maintenance and Validation – Executed by EVERSANA
Remove overhead and need for capital projects for software maintenance and validation.
Ongoing Software Validation and Maintenance (compliant with 21 CFR Part 11) executed by EVERSANA and included with subscription.
Security and Backup
User based system with automatic backup
Let Us Help You With Your Tissue Compliance Needs
Whether it’s short-term assistance or a long-term relationship, our consulting experts and outsourced services team members can help you with your compliance needs. As your trusted regulatory partner, we not only advise, but also specialize in implementation and results. Download one of our brochures to take an in-depth look of our services and case studies.
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