Technology Solutions – DES

Advancing Operations. Accelerating Compliance.

The Donor Eligibility System is an automated, web-accessible platform that assists in the donor eligibility determination process.

Donor Eligibility System

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, reduces cost and allows clinicians more time for delivery of patient care.

 

  • 40% reduction in time spent managing donor eligibility data
  • 60% average reduction in cost when compared to developing proprietary solutions
  • 120+ successful FDA inspections
  • 15 years of successful operations and client support

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.

Our system incorporates input and data from multiple sources to successfully manage:

DES Input and Data Sources

Based on inputs at each step of the donor eligibility process, the DONOR ELIGIBILITY SYSTEM by EVERSANA utilizes validated logic to identify high-risk areas and non-compliance 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).

Key features of the Donor Eligibility  System

  • Easy-to-use customer interface
  • Comprehensive dashboard that allows clinicians to track donors through the donor eligibility process.
  • Customizable questionnaires that may be sent to donors prior to their clinic appointment.
  • Configurable workflows, including approval steps, that align the system with your individual processes.
  • Management of donor records across multiple locations.
  • Seamless updates and software validation to reflect FDA changes to regulation and guidance documents.

We Help Clinics Be Operationally Excellent

The DONOR ELIGIBILITY SYSTEM by EVERSANA  addresses common challenges for any size clinic through the following:

Zero Capital Cost

  • The Donor Eligibility System is a secure, cloud-based platform built on a subscription model so there are no required software purchases.

Systems, maintenance and validation administration

  • Access to the Donor Eligibility System includes:
    • The support of our experienced systems and IT administrators
    • Quality assurance support
    • Ongoing software validation that is compliant with 21 CFR Part 11 and ongoing system audits

Best-in-class customer service

Experience hands-on, boutique-level customer service from our team of experts specializing in tissue regulation and FDA software requirements.

Automated workflows

  • Workflows integrated into the Donor Eligibility System ensure all required steps are complete in order to sign the eligibility determination, reducing the margin of error.

Peace of mind

  • Our team of regulatory experts are constantly monitoring FDA regulatory changes, updating screening and testing elements as appropriate so you can focus more on patient care.

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

 

 

 

Our Vision

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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