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.
← Different industryThe 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 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.
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.
Ask anything · No credit card · Onboard in days, not months