One platform from the collection bag to the bedside

Cellular therapy adds collection, processing, and manufacturing work to a hospital not designed for it. Title21 gives every team the same product record. This lets cells move from apheresis to the lab to the infusion unit without breaking the chain of identity.

Connected to your EHR

Orders from Epic and other EHRs start the collection procedure, and lab and instrument results map straight to the product record.

Chain of identity at every handoff

Identity and custody checks and ISBT 128 labeling follow every product from the collection bag to the bedside.

Ready for every inspection

Controlled documents, training, deviations, and audit trails stay current, so FACT, CAP, and FDA readiness is part of daily work.
Cell journey, today
Products in progress, adult and pediatric.
Live
  • COI 2026-0412AutologousInfusion
    In storage, release pending
  • COI 2026-0415 AllogeneicProcessing
    Received in lab, identity confirmed
  • COI 2026-0398AutologousFollow-up
    Infused, identity verified at bedside
  • PCOI 2026-04211AutologousCollection
    Apheresis scheduled Thursday
3Open CAPAs
96%Training compliance
0Overdue SOP reviews
Chain of identity verified at every handoff

Illustrative example

Solutions for hospitals and academic medical centers

Start with the cell journey, then add quality, manufacturing, AI, and analytics on the same platform as your program grows.

Smart-CGT

Track the cell journey

Collection, processing, manufacturing coordination, storage, and infusion on one platform, with chain of identity and custody verified at every handoff.

Explore Smart-CGT →

Smart-MES

Digitize cell processing

Electronic batch records, environmental monitoring, and cleanroom workflows for hospital cell processing and GMP manufacturing facilities.

Explore Smart-MES →

Smart-QMS

Stay accreditation ready

Document control, training and competency, deviations and CAPA, change control, and audits, built for FACT, CAP, CLIA, and 21 CFR Part 11 readiness.

Explore Smart-QMS →

Insights

See quality trends early

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

Explore Insights →

Smart-AId

Turn paper into data

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

Smart-AId →

One record from collection to infusion

Autologous or allogeneic, every product carries the same record from the collection bag to the bedside, so nothing is re-entered and nothing is lost between teams.

  1. Collection

    EHR orders start the procedure, and apheresis and marrow collections are scheduled, labeled, and handed off with custody tracked.

    Smart-CGT

  2. Receipt and processing

    The cell therapy lab confirms identity on receipt and processes each product with guided digital records.

    Smart-CGTSmart-MES

  3. Manufacturing coordination

    Slot scheduling, progress, and release status are shared with internal or external manufacturing teams.

    Smart-CGT

  4. Storage and release

    Per-donor inventory is tracked, and custody is recorded every time the product moves.

    Smart-CGT

  5. Infusion and quality

    Chain of identity is verified at the bedside, while quality events, training, and trends stay visible.

    Smart-CGTSmart-QMSInsights

Every procedure is captured and reportable, supporting best practices and ongoing improvement for future patients.

Dr. Elena Maryamchik
Director of Cell Therapy Laboratory, Memorial Sloan Kettering Cancer Center

67%

Less work time across 13 cell therapy lab procedures

215 → 70min

Total minutes across those 13 procedures

10 of 13

Procedures cut work time by 50% or more

Source: Memorial Sloan Kettering Cell Therapy Laboratory. Average work time per procedure during downtime compared with Title21 and Epic integration.

Epic and other EMRsOrders and demographics
LISLab and IDM results
Title21OOne record for every product, donor, patient, 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 your hospital already runs

Title21 connects to your EHR, LIS, instruments, and labeling, so orders, demographics, and results flow into the product record without re-keying.

Built for

FACTCAPCLIA21 CFR Part 11ISBT 128

Epic is a registered trademark of Epic Systems Corporation. Title21 Health Solutions is not affiliated with or endorsed by Epic Systems Corporation.

Business Case

Get a business case built for your program

Tell us about your program and we’ll send you a personalized business case tailored to your cellular therapy operations. It shows what paper records, manual handoffs, and inspection prep cost your teams today, and how a connected platform pays back from collection to infusion.

Tell us about your company.

See your cell journey on one platform.

Bring the handoff that slows your program down most, from collection to infusion.
We will walk through it with you on Title21.

Schedule a demo
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