Precision at every handoff

Manual workflows and disconnected systems put cell products at risk as they move between teams. Smart-CGT connects collection, processing, manufacturing, storage, and infusion in one environment.

Move cells without delays

Scheduling, labeling, and handoffs live in one place, so no product waits on paperwork between sites.

Protect chain of identity

Scheduling, documentation, and handoffs live in one place, so nothing waits on paperwork between sites.

Stay inspection-ready

Audit trails and e-signatures are built into each workflow, with no extra preparation before an inspection.
Chain of identity check
Infusion, final product verification
3 of 3 matched
  1. Patient wristbandCOI 2026-04812
    Verified
  2. Apheresis collection bagISBT 128 label, COI 2026-04812
    Verified
  3. Final product bagReleased lot, COI 2026-04812
    Verified
Match confirmed and e-signed at bedside, logged to the audit trail

Illustrative example

The cell journey, from collection to infusion

Each handoff passes the product to the next team in the same system, so its record, labels, and custody travel with it.

  1. Collection

    Schedule apheresis and collections, apply ISBT 128 labels, and start chain of identity at the source.

  2. Receipt and processing

    Confirm identity on receipt, then guide each processing step with built-in calculations and e-signatures.

  3. Manufacturing coordination

    Share slot scheduling, progress, and release status between clinical and manufacturing teams.

  4. Storage and release

    Track product inventory for every donor and record custody each time the product moves.

  5. Infusion

    Verify chain of identity at the bedside and record administration with an e-signature.

Cell journey capabilitie

Everything a cellular therapy program needs to track products, protect identity, schedule resources, and stay compliant.

End-to-end cell journey tracking

Follow each product from collection through processing, manufacturing, storage, and infusion, linked to its donor and patient

Chain of identity and chain of custody

Enforced checks at each critical step confirm that every sample and product matches the right patient.

Apheresis and collection management

Digitize scheduling, paperwork, labeling, and handoff to manufacturing, with full donation history for repeat donors.

Guided step-by-step workflows

Turn each SOP into guided steps with a progress bar, key data pinned on screen, and step-level instructions with images.

Task assignment and in-workflow actions

Assign steps to the right staff in advance, and launch a CAPA or sample order tied to the product without leaving the workflow.

Manufacturing coordination

Share real-time progress updates, slot scheduling, and release status between clinical and manufacturing teams.

Resource and capacity scheduling

Allocate staff, equipment, and consumables to each step, then drag and drop to rebalance the schedule when plans change.

Multi-tenant programs

Run separate clients, sites, or programs, such as adult and pediatric, each with its own protocols, forms, users, and integrations.

Product and inventory management

Create products, record anticoagulants, and view inventory for each donor, so every unit is accounted for.

Automated calculations

Simple and complex formulas from the built-in field library, such as product volume after sampling, remove manual math from critical steps.

Dashboards and reporting

Role-based dashboards and real-time reports on procedures, products, and quality trends.

Regulatory-ready compliance

Support 21 CFR Part 11 with e-signatures that lock completed forms, field-level audit trails with reasons for change, ICCBBA labeling, and configurable record retention.

Driving program readiness and performance

What changes when every cell product’s journey runs on one platform.

Higher patient safety

Reduce errors with enforced COI/COC, guided workflows, and real-time checks.

Faster therapy delivery

Cut manual work and remove delays from scheduling, documentation, and status tracking.

Stronger compliance

Keep complete, clean records across the entire cell journey, ready for inspection.

Better coordination

Give every team a single source of truth for each product, with shared updates and alerts.

Real-time visibility

Track every product’s status across collection centers, labs, manufacturing, and treatment sites in one view.

Supports program growth

Take on more donors, products, and programs without adding headcount or manual burden.

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.

Your SOPs, configured by your team

Change a procedure, add a form, or open a new program without waiting on a vendor. Every change is versioned and audited, so you stay ready for accreditation.

No-code form builder

Drag in text, dates, dropdowns, toggles, signatures, and formulas from a ready-made field library. Make fields required, or lock a step until the steps before it are done.

Paper to digital, fast

Upload a completed form template and Smart-CGT builds the form for you, ready for e-signature. Scanned documents can also be attached straight to the record.

Versioned workflows

Every edit creates a new version with full history, and version checks confirm each workflow runs the latest form.

Easy for every user

A simple, web-based interface, a user guide with color-coded job aids, and a team that builds your first workflows alongside you.
Donor intake
Procedure template, adult collections
Version 12
  • Text
  • Number
  • Date
  • Dropdown
  • Toggle
  • Formula
  • Signature
  1. Donor ID GRIDAnchoredGRID 9204 7731 0058 214
  2. Collection volume mLRequired312
  3. Volume after sampling mLFormula309
  4. Consent verifiedUnlocks after 2 fields
Change saved as version 12 and logged to the audit trail

Illustrative example

Epic and other EMRsOrders and demographics
LISLab and IDM results
Smart-CGTOOne record per product, donor, and patient
Instruments300+ via middleware hubs
ISBT 128 labelingLabel vendors and printers
Integration health 4 connected0 errors0 in queue

Illustrative example

Connect every system along the cell journey

Smart-CGT sits at the center of your data. Connect Epic and other EMRs, laboratory information systems, instruments, and ISBT 128 labeling, and add new connections yourself with a base URL and API key.

Results mapped to the right field

Map lab and instrument results, demographics, donor workups, and IDM results directly to forms, building one complete record.

Charts created automatically

An order placed in a connected EMR can create the patient chart and start the procedure. Manual entry is always available.

Integration health at a glance

See queued, errored, and quarantined messages and live connection status for one integration or the whole map, then drill down to resolve issues.

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

Solutions Overview

Smart-CGT at a glance

Download our two-page guide to Smart-CGT’s cell journey workflows, compliance features, and care coordination tools.

Complete the form to download.

See Smart-CGT on your cell journey

Talk with our team about protecting chain of identity, removing delays between handoffs,
and scaling your program without adding manual work.

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