One platform from collection to release

CGT developers, biopharma, pharma, and biotech teams use Title21 to run manufacturing, QC, and quality as one operation. Every lot carries the same record from the first step to release, so nothing waits on paper or a spreadsheet.

Right first time, released faster

Guided batch records catch errors as data is entered, and QA reviews by exception instead of page by page.

Chain of identity across sites

Identity and custody checks follow every autologous and allogeneic product from the collection bag through manufacturing to the treatment site.

Ready for every inspection

21 CFR Part 11 and EU Annex 11 e-signatures, complete audit trails, and one quality system keep every site inspection-ready.
Release readiness, this week
Clinical and commercial lots, all sites
Live
  • Lot CT-0412AutologousQA review
    Batch record reviewed by exception, 1 comment open
  • Lot AL-0388AllogeneicQC testing
    Potency and sterility scheduled, HPLC-02 reserved
  • Lot CT-0405AutologousReleased
    Released, chain of identity verified for shipment
  • Lot AL-0391AllogeneicManufacturing
    Step 7 of 12, guided batch record in progress
92%Right first time
14QC tests scheduled today
2Open deviations
Every lot traced from first step to release

Illustrative example

Solutions for therapy developers

For CGT developers, biopharma, pharma, and biotech. Start where release is slowest, then add the rest on the same platform as programs move toward commercial supply.

Smart-CGT

Track the cell journey

Track products from collection to treatment, verifying identity and custody at every handoff.

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Smart-MES

Release batches faster

Electronic batch records and operational controls, compliant with 21 CFR Part 11 and EU GMP Annex 11.

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Smart-QMS

Stay inspection-ready

Document control, training, deviations and CAPA, change control, and audits on one quality system shared across every site.

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Smart-QC

Keep QC off the critical path

Automate analyst and instrument scheduling, align capacity with production forecasts, and track per-test Cost of Quality.

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Smart-AId

Review records with AI

AI reads batch records, paper forms, and instrument reports, flags issues, and maintains human review and full audit trails.

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Insights

See quality trends early

Ready-made CAPA, deviation, document, and training dashboards forecast problems before inspectors find them.

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One record across the cell journey

From the collection bag to the treatment site, manufacturing, QC, and QA work from the same product record, so release decisions are made on complete data instead of chased across systems.

  1. Collection

    Collections are scheduled and labeled at each site, with chain of identity started at the collection bag.

    Smart-CGT

  2. Manufacturing

    Operators follow guided batch records, with environmental monitoring and cleanroom work in the same system.

    Smart-MES

  3. QC testing

    Tests are scheduled automatically across analysts and instruments, so QC never becomes the bottleneck.

    Smart-QC

  4. Review and release

    Batch records are reviewed by exception with AI assistance, and deviations are traced to closure.

    Smart-AIdSmart-QMS

  5. Delivery to infusion

    Chain of identity and custody follow the product to the treatment site, while leaders track quality trends across programs.

    Smart-CGTInsights

We selected Smart-QC after reviewing 17 different internal/external solutions and have implemented Smart-QC in less than 5 months in 5 of our key sites.

Johnson & Johnson
Smart-QC customer

90%

Faster batch release with Smart-MES electronic batch records

65%

Fewer batch record errors

9 of 15

Of the largest companies in the industry use Smart-QC

Batch record results are averages from Title21 client internal audits one year after implementation, client-reported. Smart-QC figures from cResults.

ERP and SAPProduction plans and expected lots
LIMSSamples, tests, and results
Title21One record for every lot, test, and quality event
EquipmentAPIs, OPC, and device integration
QMS and trainingTrackWise, LMS, and HR systems
Integration health 4 connected0 errors0 in queue

Illustrative example

Built around the systems you already run

Title21 takes production plans from ERP, samples from LIMS, and data from equipment and instruments, so every lot record is complete without re-keying. Integrations into Smart-QC are one way from your GxP systems, so they don’t need validation.

Built for

21 CFR Part 11EU GMP Annex 11GMPALCOA+ISBT 128

Business Case

Get a business case built for your programs

Tell us about your company and we’ll send you a personalized business case tailored to your manufacturing, QC, and quality operations. It shows what paper batch records, release delays, and disconnected systems cost your teams today, and how a connected platform pays back as you scale from clinical to commercial supply.

Tell us about your company.

See your path to commercial supply on one platform.

Bring a batch record, next week’s QC schedule, or your next inspection.
We will show you how it runs on Title21.

Schedule a demo
Contact sales