Cell Therapy Lab Management Software

The vendor is required to provide cell therapy lab management cloud-based system with capabilities to customize to program needs.  
•    Must be compliant with current good manufacturing practices 
o    Audit trail detailing data input and electronic sign off on each record including the ability to audit the record at each timepoint (reports of when and by whom data was entered or changed)
o    System supports multi-tiered permission-controls beyond simple ‘read-only’ and ‘power user’ designations
o    Enforce operational sequencing and functionality – forced data entry prerequisites (hard stop)
o    Support for automated calculations with verified and stored results
o    Provides software installation, set up, training and installation qualification and operational qualification validation (IQ/OQ)
o    Able to validate the configured system
•    Software must maintain compliance in updating accreditation and regulatory requirements for cellular therapy applications 
•    System interfaces at a minimum with epic and Cerner (ICENTRA) EMR systems (pull and push data) integration with CIBMTR
- Chain of custody and batch records (patient charting) for donor and recipient collections, laboratory processing, product storage and distribution
•    Record and track product quality metrics, e.g., viability, collection efficiency, recovery range of product, cd34% 
•    Record and track clinical outcomes and engraftment rates
•    Query data and use of data visualization tools to analyze historical trends
o    Assess trends and identify outliers
o    Generate standard and customizable reports
o    produce printable and hard copy versions of electronic documents and forms in human-Readable format
o    Generate summary reports for individual or multiple donors and products
o    System supports child units to be generated from parent units complete with linkages, reduced double-data entry and seamless processing
•    Ability to easily share records for review and sign off
•    Ability for users to query and retrieve records using different unique identifiers
- Consumables inventory management including lot and sub-lot type, quantities, manufacturer, distributor, uploading of quality certificates and ability to link consumables to cell therapy patient or product
•    Manages receipt, use and expiration dates of consumables
•    Par level reporting
•    Query consumables in event of recall and link to donor or product record
•    Generate, print and read bar-coded labels for consumables
- Quality management system that includes document and change control, corrective and preventative actions (CAPA), training and competency module, vendor and supplier tracking (approval and review notifications) and equipment and asset tracking, maintenance alerts and stores maintenance reports for records
- International society of blood transfusion (isbt-128) label generation and barcoding and security exchange commission compliant.
- Software supports a minimum of 10 users at a time and provides access up to 50 users at multiple sites.

- Contract Period/Term: 5 years
- Questions/Inquires Deadline: September 9, 2025