FDA Regulatory Compliance Software for Blood Services
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.
Blood Services organisations worldwide use Q-Pulse 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.
Find out how Q-Pulse can provide you with a user-friendly QMS today – reducing the time, effort and cost spent on achieving and maintaining regulatory compliance.
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, from Ideagen, 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
- 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
ISO 15189 Compliance
Q-Pulse helps medical laboratories worldwide achieve and maintain ISO 15189 accreditation.
- Ensuring effective diagnosis through accurate analytical
- Improving patient care with streamlined and robust quality
- Releasing resources to help improve service quality and