Two solutions.
One record from start to finish.

GxP Solutions manage the regulated processes of collecting, manufacturing, and releasing therapies. Business Solutions coordinate laboratory and quality activities to support these operations. Compliant AI supports both areas, from batch record review to regulatory risk management.

● GxP Solutions

Validated systems for collection, manufacturing, and quality.

Smart-CGT

Schedules collections and tracks chain of identity and custody.

Smart-MES

Guides manufacturing steps and captures electronic batch records.

Smart-QMS

Manages deviations, CAPAs, change control, documents, and training.

Insights

Unify manufacturing, quality, and clinical data with predictive analytics.

● Business Solutions

AI-assisted tools that shorten review, testing, and regulatory work.

Smart-QC

Plans and schedules QC lab capacity, analysts, and instruments.

Smart-QA

Plans and schedules QA work, including batch release and audits.

Smart-FDA

Applies AI to compliance and regulatory risk management.

Smart-AId

Turns paper records and reports into reviewed, structured data.

Built for 21 CFR Part 11 and ALCOA+ data integrity

Smart-AId

Paper records to usable data in minutes, not hours.

Train Smart-AId once on a form. From then on, it reads every page of each new record, extracts the fields you chose, and flags anything out of range, missing, or uncertain for a reviewer to confirm.

See Smart-AId in Action
Cord blood processing record
14 pages, matched to trained template
44 of 44 fields read
Extraction complete
OK 42Out of range 1Missing info 0Low confidence 1
  • Hespan volume3699%OK
  • Final volume3897%OK
  • Cord blood volume14695%OK
  • TNC × 10e91.683871%Confirm
  • % NRBC7.0898%Out of range
Reviewer confirms or overrides each value, and every action is logged in the audit trail.

*Illustrative example

①   Train

Mark the fields to read, set data types and acceptable ranges.

②  Scan or upload

Each new record is matched to its template and extracted.

③  Review

Check values side by side with the page, confirm or override.

④  Use the data

Export to CSV or send it on to analytics.

See Smart-AId in Action

Measured results from a cell therapy lab running Title21.

Integration across collection, processing, and clinical services established seamless digital workflows spanning the patient care continuum and product lifecycle.

Dr. Elena Maryamchik

Director of Cell Therapy Laboratory, Memorial Sloan Kettering Cancer Center

215 → 70 min

Total minutes across 13 cell therapy lab procedures with Title21 and Epic integration

    • Before100%
    • After30%

    96% faster

    ISBT 128 label generation, from 25 minutes to 1

      • Before100%
      • After4%

      10 of 13

      Lab 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.

      Built for every organization that makes or delivers advanced therapies.

      Choose your setting to see the workflows, products, and results that matter to your team.

      Hospitals and academic medical centers

      Run cellular therapy programs from collection through infusion, connected to your EHR.

      Includes hospital cellular therapy programs and cell therapy laboratories.

      Therapy developers

      Move from clinical to commercial supply with chain of identity and quality built in.

      Includes CGT developers, biopharma, pharma, and biotech.

      CDMOs and GMP facilities

      Manage manufacturing and quality for multiple clients and programs on on platform.

      Includes contract manufactures and GMP manufacturing facilities.

      Blood centers and biobanks

      Track collection, processing, storage, and distribution with full traceability.

      Includes blood centers, cord blood banks, and biorepositories.

      Research and clinical labs

      Turn instrument reports into structured data without re-keying, and prepare for GxP as programs mature.

      Includes R&D labs, clinical trial sites, and regenerative medicine labs.

      QC and QA teams

      Plan and schedule lab testing and quality work, from analyst capacity through batch release.

      Includes QC laboratories and QA and batch release teams.

      See your workflow running on Title21.

      Bring the process that slows your team down most.
      We will walk through it on the platform, from collection through release.

      Schedule a demo
      Contact sales