Regulatory & Compliance

Donor Eligibility System Software and Services

EVERSANA pioneered the use of software to maintain and trace donor eligibility shortly after the release of 21 CFR Part 1271 in the mid 2000’s. We have implemented our Donor Eligibility System and Services at hundreds of clients, which has helped them pass thousands of regulatory inspections over the past 15 years. The software and expert support staff help to maintain the system and are able to provide additional regulatory and/or quality support as needed.

The Donor Eligibility system implements controls compliant with 21 CFR Part 1271 and associated Guidance to take significant regulatory burden off of the clinic and staff.  Changes to regulation and guidance are continuously monitored, and the system is updated as appropriate to ensure compliance at all times. With reduced regulatory worry, staff are free to focus on what matters most to healthcare providers; delivering patient and donor care.

The EVERSANA Donor Eligibility System Solution works to solve the following elements for any size clinic.

  • Capital Costs – Zero Capital Cost
    • Services are provided on a subscription model to eliminate the need for software purchase.
  • Implementation Timeline – 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.
  • Licensing – 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

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