What employees are saying

"Regulatory compliance is important to us and our customers. CaridianBCT helps customers successfully achieve this compliance."

Mark Herzberg, Esq,
Senior Regulatory Affairs Specialist

Regulatory Q/A

Blood quality and safety are critical to the life-saving treatment provided through transfusions. Though necessary, regulations and procedures that ensure quality and safety make your job more complicated. New concerns and diseases only add to the pressure on blood centers. Each new regulation adds additional overhead and reporting to the cost of producing blood products.

Regulatory Q/ASnapshot: Some regulatory influencers in the US

  • Industry Certifications, such as tracking American Society of Clinical Pathologists (ASCP) certifications for all Specialist in Blood Banking Technology (SBB) personnel
  • CBER & CDER Regulations outline inspection by FDA's Biologics division, as well as compliance with FDA's Drug agency guidelines
  • Specific blood requirements, such as 21 CFR 606, mandates operational requirements for blood center processes throughout every phase of production
  • 21 CFR Part 11 provides for inspection of donor records and formalizes standard operating procedures
  • New diseases mean new tests and updated testing procedures, which change every time a new disease is indicated

CaridianBCT and regulatory compliance

Automating and integrating every step and process in your blood center simplifies regulatory compliance and quality assurance. The Vista Information System provides the tools and capabilities needed to ensure donor safety, improve process consistency and automate records management. It connects all the systems in your blood center, providing the transparency into each process you need to easily maintain compliance.

Find out more about how the Vista™ Information System helps ease the burden of regulatory compliance. You can also learn how the Vista Information System works with the Trima® Accel™ Collection System to optimize collections for each Trima® Collection System or Trima Accel Collection System in your blood center.

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