Blood bank software built around 21 CFR 606 and AABB — not a repurposed hospital LIS.
Donor eligibility as a hard gate, IDM-gated quarantine, ISBT 128 component labelling, transfusion service crossmatch and issue, continuous cold-chain evidence and donor-to-recipient lookback in seconds. The blood-establishment platform an FDA investigator and an AABB assessor will both read end-to-end.
You're shopping for blood bank software because your current stack was designed for hospital lab orders, not for a blood establishment under 21 CFR 606.
Donor eligibility records live in three systems and one clipboard
IDM results and component release aren't hard-gated together
ISBT 128 codes are generated outside the record and re-typed in
Lookback against a reactive donor eats a week of analyst time
Continuous cold-chain evidence is a stack of chart-recorder printouts
Transfusion-service crossmatch and issue live in a separate LIS
AABB assessment prep is a quarter-long fire drill
The blood-establishment workflow, modeled and enforced.
Donor eligibility hard gate
DHQ, physical assessment, deferral history and IDM panel all required and in-spec before a component leaves quarantine. Signed determination bound to the donor and unit.
DHQ on the kiosk
AABB Uniform Donor History Questionnaire in structured form. No free-text gaps, no misremembered deferrals, signed and attributable.
ISBT 128 in-record
DIN, product code, ABO/Rh, expiry date/time and special-testing flags generated in-record per ICCBBA and printed via validated label printers.
Donor-to-recipient lookback
Reactive donor → every prior in-date component → every consignee and recipient, in one pass. 21 CFR 610.46 / 610.47 clocks tracked automatically.
Component processing + cold chain
Split, leukoreduce, irradiate, apheresis workflows under bound e-signature. Continuous temperature stream from the fridge/freezer/incubator into the unit record.
Transfusion service
Type-and-screen, antibody workup, crossmatch, issue and post-transfusion reaction workflow — same platform as the collection side, no LIS handoff.
AABB-ready evidence
Standards-mapped document control, training, CAPA and deviation history. Assessment is a report extract, not a project.
What changes when a blood establishment has a real system.
- Donor eligibility 483 risk drops to near-zero
- Lookback closes in hours, not a week of analyst time
- ISBT 128 mis-labelling stops happening
- Cold-chain excursions surface at the fridge, not at the assessor visit
- AABB assessment prep becomes a one-day exercise
- Release cannot occur without every IDM result being in-spec and signed
Designed against the blood-establishment inspector's checklist.
21 CFR Part 606 / 630 / 640
cGMP for blood and blood components, donor eligibility, and product-specific requirements (whole blood, red cells, platelets, plasma, apheresis) all modeled natively.
AABB Standards
Donor qualification, collection, component processing, storage, transportation, transfusion service and quality system evidence mapped to the current Standards for Blood Banks and Transfusion Services.
21 CFR Part 11 / ISBT 128
Bound e-signatures, hash-chained audit trail, RBAC; ISBT 128 DIN, product codes and barcode encoding generated in-record per ICCBBA.
EU 2002/98/EC + 2005/61/EC
European blood-safety directives — traceability, haemovigilance and serious adverse reaction/event reporting supported for cross-border operations.
Blood bank software, answered.
What is blood bank software?
Blood bank software is the system of record for a blood establishment — donor registration and eligibility (including the DHQ), collection, IDM testing, component processing under 21 CFR 606 / 630 / 640, ISBT 128 labelling, cold-chain storage, distribution and (where applicable) transfusion service — with a Part 11 audit trail tying it all together. It replaces paper, spreadsheets and single-purpose LIS modules with a single platform.
Does V5 support 21 CFR Part 606 and AABB?
Yes — natively. Donor eligibility, cGMP component processing, labelling, quality system evidence, adverse-reaction and biological-product deviation reporting are all modeled. Release is a hard gate; a component cannot be issued without every IDM result in-spec and a signed Medical Director determination.
Does V5 generate ISBT 128 labels?
Yes — DIN, product code, ABO/Rh, expiration date/time and special-testing encoding are generated in-record per ICCBBA and printed via validated label printers. Codes are never retyped from a different system.
How does lookback work?
When a donor goes reactive, V5 runs a forward-trace query: every prior in-date donation, every component, every consignee and (in transfusion service) every recipient. The 3-day quarantine and 45-day notification clocks under 21 CFR 610.46 / 610.47 are tracked and reported automatically.
Can V5 run both collection and transfusion service?
Yes. Type-and-screen, antibody workup, crossmatch, issue and post-transfusion reaction management live on the same platform as donor collection and component processing. No separate LIS, no reconciliation.
How long does implementation take?
Most blood establishments run their first signed component release within 30 days of kickoff. Full multi-site rollouts (mobile collections, processing centre, transfusion service) typically take 8–20 weeks depending on integration count.
Make 21 CFR 606 and AABB part of how the establishment runs — not a quarterly fire drill.
Free trial. Real blood-bank workflow. No sales gate.