Quality System Outsourcing

EVERSANA’s Quality System Outsourcing solutions have been implemented for hundreds of clients, which has helped them pass thousands of regulatory inspections over the past 20 years. As part of our commitment to quality internally, and externally for the services we provide for our clients, we have maintained ISO 13485 and 9001 Certification of our Quality Management System for over 10 years – one of the first service providers ever to do so.

Quality Management System Solution

Quality System solutions can be implemented in a phase based approach to right size the Quality System for the Company and/or Product’s current lifecycle. Our Quality Systems solutions come compliant to the latest FDA and ISO requirements and can be customized to include requirements for any regulatory agency. These solutions include systems tailored for Medical Device, Pharmaceutical, Biologic, Tissue, and Combination Products.

Clients having an existing QMS, and looking to extend their product portfolio, or creating a Combination Product can also benefit from EVERSANA’s “Bolt-On” QMS. The “Bolt-On” QMS allows use of the current QMS while only adding (or “Bolting On”) elements required to satisfy the additional regulatory requirements.

The EVERSANA Quality Management System Solution works to solve the following elements when considering the implementation of a Quality System.

  • Right size QMS
    • Implement what you need when you need it.
    • Expert QA/RA support available to help identify what QMS elements are needed and when.
  • Cost effective and timely
    • Reduce implementation time.
    • Expedited implementations available (≤4 weeks in some instances).
  • Compliance
    • Base QMS available for out of the box FDA and/or ISO compliance
  • Expert QA/RA support available to customize for any market / regulatory agency.

Document Control and Training Management Software and Services

Our fully validated 21 CFR Part 11 compliant software, along with our expert staff of document administrators and training coordinators provide an all-encompassing solution to your document control and training needs. Whether you are a startup looking to establish a document and training management system, currently managing documentation and training manually, looking for a cost effective software solution, or simply looking to reduce overall cost and overhead, EVERSANA has a customized solution to fit your company regardless of company size or lifecycle state.

The EVERSANA document control solution works to solve the following elements when considering the implementation of a Document and/or Training Management system.

  • Capital Costs – Zero Capital Cost
    • Services are provided on a subscription model to eliminate the need for software purchase and other initial setup costs.
  • Implementation Timeline – Experienced staff and prevalidated system reduce implementation timeline
    • Right sized implementation with little to no impact to current operations
    • Expedited implementations available (≤4 weeks in some instances).
  • Cloud system – Fully web-based
    • Full access to documents and records from anywhere with an internet connection.
    • No need to manage and store documents and records manually.
  • Control – Permission Based Control
    • Allow users access to documents based on role, need and/or job function.
    • Allow suppliers, clients or potential investors access to relevant documentation.
  • Licensing – Unlimited Licenses provided with subscription.
  • Staffing – Dedicated EVERSANA resources
    • Systems administered and managed by EVERSANA resources.
      • System Administrator
      • IT Administrator
      • Quality Assurance Support (As requested QA support during audits for Document/Training system inquiries).
    • Maintenance and Validation – Executed by EVERSANA
      • Remove overhead and need for expensive 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
      • User permissions.
      • Encrypted data and backups.
      • Class-One Data Warehouse with multiple redundancies.
      • SOC II Type 2 compliant.
    • Sustainability and Growth – Customized solutions for any size company
      • Ability to flex support to facilitate short term high volume or long term growth.

 

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. 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 prevalidated 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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