Technology Solutions – DES

Advancing Operations. Accelerating Compliance.

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 EVERSANA utilizes 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

  • System Administrator
  • IT Administrator
  • 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.
  • System audits.

Security and Backup

  • User based system with automatic backup
  • User permissions

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.

Donor Eligibility Outsourcing Services

Tissue Compliance Solutions

FDA Compliance Solutions

 

 

 

Experience our newly updated Donor Eligibility System, in partnership with Reprotech

How can we help manage clinic operations in a compliant way.  Schedule a demo session with us to see our state-of-the-art software in action.

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Contact us to learn more.

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