One platform from donor to distribution

Organizations that collect, process, store, and distribute biomaterials use Title21 to run every step as a single operation. Each unit carries the same record from the donor through processing, storage, and release. This way, nothing is re-entered or lost.

Donor history in one place

Repeat donors keep a full donation history, and every collection is scheduled, labeled, and linked to its donor.

Traceability at every handoff

Chain of identity and custody checks and ISBT 128 labeling follow every unit through processing, storage, and distribution.

Ready for every inspection

Controlled documents, training, deviations, and audit trails stay current, so AABB, FACT, and FDA readiness is part of daily work.
Unit tracking, today
Collections, processing, and inventory
Live
  • W0412 26 004812Cord bloodStorage
    In storage, available for release
  • W0412 26 004815ApheresisProcessing
    Received in lab, identity confirmed
  • W0412 26 004798Cord bloodDistribution
    Released, custody recorded at handoff
  • W0412 26 004821MarrowCollection
    Collection scheduled, donor history on file
2Open CAPAs
98%Training compliance
0Overdue SOP reviews
Every unit traced from donor to distribution

Illustrative example

Solutions for blood centers and biobanks

For organizations that collect, process, store, and distribute biomaterials. Start with unit traceability or quality, then add the rest on the same platform as you grow.

Smart-CGT

Trace every unit

Unify collection through release with donor history, ISBT 128 labeling, and identity and custody tracking.

Explore Smart-CGT →

Smart-QMS

Stay inspection-ready

Centralize documents, training, competency, deviations, CAPA, change control, and audits across sites.

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Smart-MES

Digitize processing

Electronic batch records, environmental monitoring, and cleanroom workflows for processing labs and GMP facilities.

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Insights

See quality trends early

Ready-made dashboards for CAPAs, deviations, documents, and training, with completion forecasts before an inspection.

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Smart-AId

Turn paper into data

AI that extracts values from paper forms, legacy records, and instrument reports, with a human review step and a full audit trail.

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One record from donor to distribution

Every unit carries the same record through collection, processing, testing, storage, and release, so nothing is re-entered and nothing is lost between teams.

  1. Donor and collection

    Donors are screened against your criteria, collections are scheduled and labeled, and repeat donors keep a full history.

    Smart-CGT

  2. Receipt and processing

    Units are confirmed on receipt and processed with guided digital records and built-in calculations.

    Smart-CGTSmart-MES

  3. Testing and results

    Lab and IDM results flow in from your LIS and instruments and map straight to each unit’s record.

    Smart-CGT

  4. Storage and inventory

    Per-donor inventory is tracked, and custody is recorded every time a unit moves.

    Smart-CGT

  5. Release and quality

    Units are released with complete records, while quality events, training, and trends stay visible.

    Smart-CGTSmart-QMSInsights

The success factor for ImpactLife was maximizing the benefits on an electronic system.

Director of Regulatory Compliance
ImpactLife

82%

Fewer hard copy manuals

208 days

Of staff time saved each year managing manuals

19 hrs

Less time on version control each week

Source: ImpactLife document control case study, Smart-QMS.

Donor and registry systemsAPI connections to your platforms
LISLab and IDM results
Title21One record for every unit, donor, and quality event
Instruments300+ via middleware hubs
ISBT 128 labelingLabel vendors and printers
Integration health 4 connected0 errors0 in queue

Illustrative example

Built around the systems you already run

Title21 connects to your LIS, instruments, labeling, and donor systems, so results and demographics flow into each unit’s record without re-keying, and your IT team can monitor every connection.

Built for

AABBFACT21 CFR Part 11ISBT 128

Business Case

Get a business case built for your organization

Tell us about your organization and we’ll send you a personalized business case tailored to your collection, processing, and storage operations. It shows what paper records, manual traceability, and inspection prep cost your teams today, and how an affordable, connected platform pays back, including new revenue opportunities from your existing programs.

Tell us about your company.

See every unit’s journey on one platform.

Bring the handoff that slows your team down most, from donor to distribution. We will walk through it with you on Title21.

Schedule a demo
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