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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

Collect

Electronically capture each harvest and product collection including full lot-to-lot traceability, ISBT 128, SEC 128 and third party collection label generation, 21 CFR Part 11 compliant electronic signatures and more.

Process

You need a flexible solution to seamlessly document the complete lifecycle for every product, aliquot and sample. STEMSOFT automates full chain of custody for all of your products, includes built-in ISBT 128 and SEC product labels and provides you with the flexibility you need to document the data you care about including interfaced test results, shipment details, automated calculations, verification activities, scanned documents, full consumable and equipment traceability, clinical outcomes and more.

Store

Being able to identify exactly where your units are located is imperative to your operations. STEMSOFT lets you electronically track and assign all storage locations making it easy for you to store or retrieve products without compromising integrity.

Infuse

Electronically document all of your cell therapy infusions including standard of care and novel cell therapies while enabling your care team to efficiently and securely document detailed protocols, donor information, generate ISBT 128 labels and more from the convenience of a mobile device.

Analyze

Aggregating data is one thing but mining your data is key. STEMSOFT keeps all your critical data elements in one place and lets you perform ad-hoc queries and generate visualizations on the fly without having to be a report writing expert. Automated and on-demand business intelligence and visualization is also included to provide you with your weekly dashboard, key quality indicators, completed paperwork and more.

Your Software Solution

STEMSOFT LAB

Track all of your unique operational and manufacturing details in one platform, with built-in support for accreditation compliance, processing standardization and data analysis.

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Receive Extended Support with Your STEMSOFT Solution

At STEMSOFT, we know that the proper software solution is only one piece of your cell therapy program. That’s why we’re proud to offer additional services and resources to help you get the most out of your STEMSOFT system.

Support Portal

As a valued client, you’ll gain access to our users-only Support Portal offering extensive supporting documentation, example Standard Operating Procedures (SOPs), a searchable knowledgebase, video library, newsletters, and more.

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Software Implementation and Ongoing Support

With over 25 years of experience in implementing cellular therapy software solutions, we have developed a structured training approach that will enable your team to easily get started with STEMSOFT today while also providing you with the ongoing training, upgrades, and support you need for the long term.

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