WellSky Biotherapies Lab provides an integrated platform that supports complex manufacturing protocols and workflows in cell therapy and regenerative medicine. The software facilitates the management of both finished products and manufacturing intermediates, ensuring precise tracking and traceability. It enables verification of equipment calibrations, automates calculations and procedures, and records materials consumption, all contributing to streamlined operations. The system's interoperability is enhanced through WellSky’s Intelligent Integration engine, which manages bi-directional data exchange with electronic medical records (EMRs), laboratory information systems (LIS), instruments, and testing labs, utilizing standards such as HL7 FHIR. This integration reduces manual data entry and potential errors, saving time while increasing quality. Additionally, the platform offers comprehensive management of donation and collection processes across multiple service lines, supporting the configuration of critical donor forms and work-ups, and allowing for the complete management of the entire collection process. WellSky Biotherapies Lab also includes features for label printing, equipment and materials management, and a web portal that allows donors and patients to provide essential data, such as health histories and consents, thereby streamlining activities like sharing patient outcomes data and searching and ordering research products. Features:

• Optimized Manufacturing Tools: Configure custom forms and procedures, improve documentation of manufacturing processes through tools such as auto-calculations, dynamic grids, workflow triggers and alerts, prescribed variabilities, and electronic signatures, streamlining processes for staff while ensuring quality and compliance.
• Label Printing: Print fully compliant ISBT-128 label sets or generate custom labels specific to research projects or clinical trials with integration to labeling solutions like Digi-Trax’s Hema-Trax®-CT.
• Equipment & Materials Management: Simplify the management of materials and equipment with dedicated home pages for each equipment type, allowing for the upload of critical information, label printing, and assignment of use statuses.
• Donor Collection Management: Provide comprehensive management of donation and collection processes across multiple service lines, fully supporting the configuration of critical donor forms and work-ups, and allowing for the complete management of the entire collection process.
• Informatics: Access improved metrics that allow for greater availability of process and support materials data to help measure and improve yield and success rates, support continuous process improvement efforts, and track and trend process outcomes.
• Interoperability: Manage system integration through WellSky’s Intelligent Integration engine, streamlining bi-directional integration with data sources such as EMRs, LIS, instruments, and testing labs through proven integration technology and emerging standards such as HL7 FHIR.
• Web Portal: Enable donors and patients to provide essential data, such as health histories and consents, connecting research and clinical programs with laboratories, and streamlining activities such as sharing patient outcomes data and searching and ordering research products.