Title21 Batch Record Solution streamlines the process of approving cell therapy products for lab release, infusion and transplant by ensuring complete and accurate data collection and traceability throughout operations.
Workflows and electronic forms have logic and thresholds enabling visible flags to alert missing critical data, incompatibilities, or deviations according to defined parameters.
Assemble donor and recipient testing data for a full review and e-signature sign-off.
Critical materials that come into contact with the cell therapy product are identified including unique IDs, manufacturer, lot number and expiration dates.
All steps of the process are documented on the record and can be reviewed including product labeling and cryopreservation steps.
Lab release and patient charts are electronically routed for review and e-signature approval.
Documentation gaps, errors, or patient safety concerns are alerted to the user throughout the workflow, facilitating and efficient review and sign-off.
Manually assembling patient and processing information through disconnected paper forms is tedious and leaves room for missing data – Title21 Batch Record Solution enables automated and accurate data review.
Rely on a validated, electronic system to facilitate proper approval for the safe distribution of cell therapy products.