Blood Bank Software For FDA Regulatory Compliance

Organisations worldwide use Ideagen's quality management system (QMS) software to help ensure the collection, testing, processing, storage and distribution of blood is performed in a robust, quality-assured environment. Organisations such as Scottish National Blood Transfusion Service, the Blood Bank of Alaska, Sligo General Hospital, NHS Blood & Transplant and Rhode Island Blood Center, use Q-Pulse to reduce the time and cost spent managing regulatory compliance.

Achieving and maintaining compliance with the numerous regulations and standards within the Blood and Tissue sector such as the FDA’s 21 CFR, AABB, CLIA-88, the EU Blood Directive, NetCord-FACT, ISO 15189 and ISO 17025, all require time, effort and money. Strict quality and safety requirements demanded by these regulators means organisations must implement an effective system to integrate and centralise all their quality processes and procedures in order to easily demonstrate compliance.

Find out how our QMS software can help you reduce the time, effort and cost spent on achieving and maintaining regulatory compliance.

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Ideagen helps Anthony Nolan comply with NetCord-FACT standards and strengthen processes for patient safety

“Having looked at competitive systems, we found that Q-Pulse delivers real value for blood operations such as ourselves; Q-Pulse integrates easily with our existing systems and gives us exactly what we were looking for, for considerably less than comparable systems...we’ve made huge savings in time, effort and cost in terms of managing our information.”

Marilyn Jeffers, Project Manager for Quality Assurance at Blood Bank of Alaska

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ISO 15189 accreditation

As an internationally recognised standard, ISO 15189 serves to assure the quality and competence of processes and staff in medical laboratories across the globe: in the UK alone, up to 80% of clinical diagnoses depend on laboratory test results.

Ideagen supports more than 160 medical laboratories around the world in managing the requirements of laboratory accreditation, including ISO 15189, in order to improve the quality and reliability of services and contribute to the continual improvement of care.

Ideagen’s Q-Pulse QMS software helps medical laboratories worldwide to achieve and maintain ISO 15189 accreditation by:

  • Ensuring effective diagnosis through accurate analytical work
  • Improving patient care with streamlined and robust quality processes
  • Releasing resources to help improve service quality and reliability

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Process Based Model

Find out how Q-Pulse can operate as quality management software to assure quality and maintain compliance in the Blood and Tissue sector.

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