Tissue bank software built around 21 CFR 1271 and AATB accreditation — not retrofitted from a generic QMS.
Donor eligibility as a hard gate, DRAI on the kiosk, ISBT 128 labelling, lookback as a single query, cGTP processing records, and a signed Part-11 audit trail. The tissue bank platform an FDA investigator and an AATB inspector will both read end-to-end.
You're shopping for tissue bank software because the regulatory burden has outgrown paper and SharePoint.
Donor eligibility records live in three different folders and one inbox
DRAI gaps were cited in your last FDA inspection
Lookback takes a week of analyst time per reactive donor
ISBT 128 labelling is generated outside the record and re-typed in
AATB self-assessment is a quarter-long fire drill
Release happens before all IDM results are confirmed in-spec
The tissue-bank workflow, modeled and enforced.
Donor eligibility gate
DRAI, medical history, physical assessment, and IDM panel all required and in-spec before a unit can leave quarantine. Responsible Person e-signature bound to the record.
DRAI on the kiosk
Structured Donor Risk Assessment Interview with the FDA-aligned question set. No free-text gaps. Signed, timestamped, attributable.
ISBT 128 labelling
DIN, product code, expiration encoding, special-testing flags — generated in the record and printed via validated label printers, not retyped.
Lookback in one query
Forward trace from a reactive donor to every consignee and recipient in seconds. 21 CFR 610.46 / 610.47 / 1271.150 obligations met on time, every time.
cGTP processing records
Recovery, processing, sterilisation, packaging, and release — all under bound e-signature with hash-chained audit trail.
AATB-ready evidence
Standards-mapped document control, training records, CAPA, and deviation history. Self-assessment is a report, not a project.
What changes when tissue-bank operations have a real system.
- Donor eligibility 483 risk drops to near-zero
- Lookback completed in hours, not weeks
- ISBT 128 labelling errors stop happening
- AATB self-assessment becomes a one-day exercise
- Release decisions are made by the system, not chased by QA
Designed against the tissue-bank inspector's checklist.
21 CFR Part 1271
Registration & listing, donor eligibility (Subpart C, including DRAI under 1271.75), cGTP processing controls, labelling, deviation reporting — all modeled natively.
AATB Standards
Donor screening, recovery, processing validation, sterilisation, packaging integrity, labelling, and distribution — evidence captured in the standards-mapped quality system.
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.
Tissue bank software, answered.
What is tissue bank software?
Tissue bank software is the system of record for an HCT/P establishment — donor eligibility (including the DRAI under 21 CFR 1271.75), recovery, processing, sterilisation, labelling under ISBT 128, storage, distribution, and the cGTP audit trail tying it all together. It replaces paper, spreadsheets, and SharePoint with a single platform that an FDA investigator and an AATB inspector can both read.
Does V5 support 21 CFR Part 1271?
Yes — natively. Establishment registration data, donor eligibility (Subpart C including the DRAI), cGTP processing (Subpart D), labelling, adverse-reaction and HCT/P deviation reporting (Subparts E/F) are all modeled. Eligibility is a hard gate; release cannot occur without complete in-spec IDM results and a signed Responsible Person determination.
Does V5 generate ISBT 128 labels?
Yes — DIN, product code, ABO/Rh (where applicable), expiration date/time, and special-testing encoding are generated in-record per ICCBBA and printed via validated label printers. Codes are not retyped from a different system.
How does lookback work?
When a donor goes reactive, V5 runs a forward-trace query: every in-date component from every prior donation, every consignee, every downstream record. The 3-day quarantine and 45-day consignee notification clocks under 21 CFR 610.46 / 610.47 / 1271.150 are tracked and reported automatically.
Is V5 AATB-ready?
Yes. Document control, training records, CAPA, deviation management, and evidence capture are mapped to AATB Standards for Tissue Banking. The self-assessment is a report extract, not a quarter-long project.
How long does implementation take?
Most tissue banks run their first signed eligibility determination within 30 days of kickoff. Full multi-line rollouts (recovery sites, processing, distribution) typically take 8–16 weeks depending on integration complexity.
Make 21 CFR 1271 and AATB part of how operations runs — not a quarterly fire drill.
Free trial. Real tissue-bank workflow. No sales gate.