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Blood Bank System Validation Services

JTG offers full validation services compliant with regulatory requirements, following the standards and guidelines provided by AABB, CAP, FDA, ISBT, and other agencies for blood bank systems such as: SCC SoftBank® and SoftDonor®, Sunquest Blood Bank™, Cerner Millennium®, WellSky Transfusion (Mediware), and Haemonetics® SafeTrace Tx®. Our team has over 150 years of combined extensive blood banking experience to deliver the premium level service JTG is known for. Our testing is patient safety focused, thorough, and we address requirements completely and efficiently to ensure minimal disruption to your staff and daily operations.  


We create the validation plan, design scenarios, and perform and fully document testing for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). We can also take care of any system testing based on manufacturer General Testing Guidelines (GTGs), Client Test Plans (CTPs), and perform Mapped Record Testing (MRT).  A complete validation report including risk assessment is provided to ensure clients are audit-ready, and training is available.


We are dedicated to making the process as easy as possible for our clients. There are no time-consuming and burdensome questionnaires to fill out, and no additional testing required of your staff. JTG gathers information from our client during a kickoff call and then we’re on our way. With brief weekly client check-ins to discuss and quickly address any potential issues, projects run smoothly and on schedule.


Our structured approach and proprietary automated tools accurately and efficiently capture and produce the documented evidence our clients need, providing them a high degree of assurance the system is compliant with regulatory standards and works correctly and consistently.


Our Blood Bank system validation services include:

  • Project Creation and Preparation

  • Preparation and execution of GTGs, CTPs, and MRT

  • Preparation and execution of validation plan and protocols

    • Installation Qualification (IQ) Validation

    • Operational Qualification (OQ) Validation

    • Performance Qualification (PQ) Validation

  • Preparation and execution of End User training plans (Optional)

  • Validation Documentation

  • Validation Overview

  • Patient/Unit Validation results including issues identified and remediation

  • Interpretation results including issues identified and remediation

  • Scenario result including issues identified and remediation

  • Validation Summary document (Validation start/stop dates)

  • Risk Assessment

  • Blood Bank Validation QA warnings

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