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STEMSOFT FOR

IEC and CAR-T Cell Therapy Providers

The toolkit you need to electronically document and analyze your Immune Effector Cells (IEC) and CAR-T work including:

  • Patient and consent tracking
  • Apheresis collection, traceability and ISBT-128 labeling including the ISBT 128 Full Product for Cellular Therapy Manufacturing (CT) label
  • Sponsor information
  • Materials management (both internal and external)
  • Chain of custody
  • Chain of identity
  • Processing and manipulations, including rescue cryopreservation of excess cells
  • Shipment and logistics to Contract Manufacturing Organization (CMO)
  • Receipt, quarantine storage and release of the CAR-T product from the CMO
  • 21 CFR Part 11 and Annex 11 compliant electronic signatures
  • Clinical outcomes and engraftment
  • Adverse events, adverse reactions and Occurrences
  • Analytics and data visualizations

STEMSOFT eBPR software helps you reduce redundant data entry, slips, lapses, and mistakes while also making it easier to maintain complete and accurate manufacturing records. Our software can help you maintain your FACT/JACIE and AABB accreditation and  ensures compliance with cGMP,  cGTP, GDPR, HIPAA and more.

Our proprietary Jump Start Implementation Program can help your team get up and running quickly with a proven solution including: 

  • Standardized, scheduled training with presentation materials, case studies, homework and quizzes to reinforce the live sessions
  • Access to a training site to practice at your pace
  • Access to industry standard workflows
  • Sample process documents to help organize your laboratory processes
  • Sample Standard Operating Procedures
  • Related supporting documentation for accreditation and regulatory compliance

Book your demonstration today and learn how STEMSOFT will help you take control of your CAR-T processes.

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Software Solutions to Support Your Cell Therapy Workflow