Blood Bank Software For FDA Regulatory Compliance
Organisations worldwide use Ideagen's blood bank 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, MountainStar Blood Services, NHS Blood & Transplant and Rhode Island Blood Center, use Q-Pulse to reduce their 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 17125, 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, to easily demonstrate compliance.
Find out how our blood bank software can help you reduce the time, effort and cost spent on achieving and maintaining regulatory compliance.
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Compliance, Efficiency, Safety and Productivity
The College of American Pathologists (CAP), Clinical Pathology Accreditation (CPA), Medicines and Healthcare Products Regulatory Agency (MHRA) and the Food and Drug Administration (FDA) are committed to ensuring quality and best practice is maintained to a high level. Compliance with ISO 15189 demands commitment to operational excellence and this places a burden of work on the laboratory.
The historic management approach of fragmented systems, paper and manual processes, electronic documents, spreadsheets and email is inadequate and creates a crippling bureaucratic burden. Q-Pulse is a fully integrated Electronic Quality Management Solution (eQMS) that helps laboratories transform their operational processes and substantially decrease the time spent on compliance activities.
- Audits must be carried out to ensure these procedures are followed.
- Staff can easily report problems.
- Assets must calibrated and maintained with an audit trail.
- Suppliers must be audited to ensure their products and services are of the necessary standard.
- Risks must be identified and treated.
- Staff must be shown to be competent.
“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