Every unit ships with a signed donor-to-distribution record an FDA investigator could sign off on.
Built for 21 CFR 1271 (HCT/Ps), 21 CFR 606 / 630 / 640 (blood cGMP), AABB and AATB standards, and ISBT 128 labeling.
The codes you're accountable to — at the data layer.
Five steps from receive to release — with the regulator on the hook at the end.
Tap to expand · download as PNG · paste into an audit prep deck.
From login to release — no end-of-shift paperwork.
- › donor id
- › eligibility
- › deferral chk
- › consent
- › DIN
- › volume
- › phlebotomist
- › time
- › NAT / serology
- › ABO / Rh
- › QC sig
- › result
- › component id
- › method
- › yield
- › operator
- › quarantine st.
- › med-dir sig
- › two e-sigs
- › release
- › ISBT 128
- › product code
- › expiry
- › consignee
- 07:00·step 01Donor intake
Donor arrives. Eligibility questionnaire, vitals, deferral history pulled live. Reactive history → auto-defer; the phlebotomist never sees a 'maybe'.
21 CFR 630 / 1271 Subpart C - 08:00·step 02Collection
DIN scanned at the chair. Whole blood, apheresis, or tissue recovery — volume, duration, phlebotomist e-sig all captured to the unit record.
21 CFR 606.160 / AABB Std 5 - 10:30·step 03IDM testing
Sample tubes route to the lab. NAT + serology + ABO/Rh stream back to the unit. Until they're complete and in-spec, the unit cannot leave quarantine.
21 CFR 610 / 630 - 12:00·step 04Processing
Whole blood → components (RBC, plasma, platelets) or tissue recovery → graft processing. Method, yield, operator e-sig on each step.
- 14:00·step 05Medical-director release
Med-dir reviews the assembled record — donor eligibility, IDM, processing, visual inspection. Two e-sigs close the unit for release.
21 CFR 606.100 - 15:30·step 06ISBT 128 label + ship
Label prints with the ISBT 128 DIN, product code, expiry, ABO/Rh. Barcode verified before the unit leaves the building. Consignee scan captures chain of custody.
ISBT 128 / AABB Std 5.1 - Any time·step 07Lookback
A reactive post-donation result triggers automatic lookback: every component from that donor, every consignee, every recipient — resolved in seconds, not days.
21 CFR 610.46 / 610.47
The terms your auditor uses
- HCT/P
- Human Cells, Tissues, and Cellular & Tissue-Based Products — the FDA category covering tissue allografts (21 CFR 1271).
- DIN
- Donation Identification Number — the unique code assigned at collection and carried through every component.
- IDM
- Infectious Disease Marker testing — the serology + NAT panel every donation is screened against.
- ISBT 128
- Global standard for labeling Medical Products of Human Origin — required by FDA, AABB, AATB, and most national regulators.
- Lookback
- The required forward trace from a reactive donor to every component, consignee, and recipient (21 CFR 610.46 / 610.47).
- AABB / AATB
- Accreditation bodies for blood banks (AABB) and tissue banks (AATB) — both audit on top of the FDA baseline.
- Quarantine release
- The control that prevents an in-process unit from being distributed until all IDM testing is complete and in-spec.
Sound familiar? We built this for you.
Donor eligibility, IDM testing, and product release live in different systems — release happens before serology is back, or the unit sits in quarantine because nobody reconciled it.
Lookback for a reactive donor is a multi-day binder hunt across donations, components, and consignees.
ISBT 128 labels are reprinted by hand when a barcode smudges — there's no audit trail tying the reprint to the original.
Cold-chain excursions on platelets, plasma, or tissue grafts get caught at month-end, not at the moment of excursion.
AABB / AATB and FDA Form 483s flag the same gap every cycle: SOP-of-record vs SOP-actually-followed.
The workflows you'd expect to see on day one.
Not a generic feature list — these are the specific blood & tissue workflows V5 ships configured for, ready to run on your batches.
Donor intake & eligibility
Donor ID, deferral check, eligibility questionnaire, and consent captured before collection.
Collection + DIN assignment
Donation Identification Number, volume, phlebotomist, and times captured at collection.
IDM / NAT / serology results
Infectious disease marker results gate quarantine release; reactive units segregated automatically.
Component processing & yield
Per-component method, yield, and lot lineage tracked from whole blood / apheresis through to graft.
Two-sig quarantine release
Medical director + QA e-sigs required to move from quarantine to distributable inventory.
ISBT 128 labeling & lookback
ISBT 128 product code, expiry, and consignee on every unit; donor-to-recipient lookback in seconds.
The record assembles itself as the work happens.
No paperwork project at end of shift. No reconstruction at audit time. The evidence IS the workflow.
Donor-record + processing-record, together
Donor eligibility determination, vitals, deferral history, IDM panel, processing steps, and release decision live on one immutable record per unit.
Hard-gated release
A unit cannot move from quarantine to distribution until IDM testing is complete, in-spec, and medical-director e-signed. No exceptions, no overrides without a recorded reason.
Donor-to-recipient lookback in seconds
Forward genealogy from donor → collection → components → finished labels → consignee. A reactive donor produces a complete recall scope in one query.
ISBT 128 compliant labeling
Data Identifiers, product codes, and donation identification number generated and verified at every handoff. Reprint events are signed and traceable to the original.
Cold-chain CCPs with auto-quarantine
Storage and shipping temperatures monitored against product-specific limits. Excursions auto-hold affected units and open a deviation — they don't wait for month-end review.
Self-building audit packet
AABB, AATB, FACT-JACIE and FDA BIMO inspections all read the same record — typed, hashed, signed, ALCOA+. No end-of-cycle paperwork project.
Plain-English playbooks for Blood & Tissue regulations.
Structure, recurring inspection findings, and a practical 60-day path — written for QA, regulatory and operations leads.
Readiness guide for blood banks and transfusion services against the AABB Standards for Blood Banks and Transfusion Services (33rd ed.) and 21 CFR 600/606/610.
Readiness guide for EU tissue and cell establishments — Directive 2004/23/EC, implementing Directives 2006/17 and 2006/86, the SoHO Regulation transition and competent authority inspection.
Readiness guide for human cells, tissues, and cellular and tissue-based products under 21 CFR Part 1271 — registration, donor eligibility, CGTP, adverse reaction reporting and 361 vs 351 boundary.
Plain-English guide to NIS2 (Directive (EU) 2022/2555) and DORA — Article 21 measures, 24/72-hour incident reporting, ICT third-party risk and how NIS2 stacks on Annex 11 and ISO 27001 for tissue establishments and blood banks.
Plain-English guide to the ISPE GAMP Records & Data Integrity (RDI) Good Practice Guide — ALCOA+, data lifecycle, hybrid records, audit trail review, and a defensible RDI programme aligned with MHRA, FDA, WHO and PIC/S expectations.
Plain-English guide to ICH E6(R3) — Quality by Design, Critical-to-Quality factors, sponsor and investigator duties, Annex 2 computerised systems and a defensible GCP programme for cell, tissue and advanced therapy clinical investigations.
Spin up a workspace seeded for Blood & Tissue.
Default templates, validation rules, and report packs are pre-loaded for your industry. Run a real batch in under an hour.
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