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            Get to Know Custody Management

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            Get to Know Custody Management

            Advanced Therapy Management’s Chain of Custody (CoC) and Chain of Identity (CoI) capabilities help you comply with pharmaceutical regulations and uphold safety standards across the lifecycle of an advanced therapy. CoC helps you maintain a digital trail of the patient’s collected biosample as it passes through the various stages, steps, and tasks of an advanced therapy. CoI ensures that the right patient receives the right treatment by assigning a unique identifier to the collected biosample.

            Required Editions

            Available in: Lightning Experience

            Available in: Enterprise and Unlimited Editions with Health Cloud or Life Sciences Cloud

            You can create custody records automatically as part of Advanced Therapy Management’s Therapy Orchestration. When you create an enrollee record, Therapy Orchestration is set in motion. When a care program enrollee work order (such as Apheresis) is in progress, the Override Custody Verification Type When Work Order Is Changed flow creates the related custody records. When a care program enrollee work order step (Identity Verification) is in progress, the Override Custody Verification Type When Work Order Step Is Changed flow creates the related custody records.

            You can create electronic signature records for chain of custody entries automatically by creating a flow or overriding a managed flow. You can also use a subflow to confirm if all signatures on a trail are complete.

            The Evaluate Step and Task Completion Status flow checks whether custody of a biosample for each step and task has been fulfilled. The Process Advanced Therapy Work Orders orchestration flow moves on to the following step, if any, only after custody is complete.

            As part of CoI, you assign a unique identifier that represents the biosample (custody item). The identifier can originate in Salesforce or from external systems. Maintaining the CoI ensures the integrity of the custody item.

            • Configure Custody Records With Workflows
              To successfully execute the therapy orchestration workflows and capture custody data, set up a Custody Verification Type Override decision table and create a Custody Verification Type Override record.
            • Configure Chain of Identity for a Custody Item
              When the Create Custody Chain Entries flow is executed, it creates custody items and custody chain entries. Add a unique identifier to the custody item to maintain a chain of identity throughout all the therapy orchestration processes.
            • Track Chain of Custody Data
              Capture all custody-related changes in a therapy orchestration workflow, including the date and time of past events, and new data that’s generated after every change. Ensure regulation compliance by tracking and auditing the history of chain of custody events.
             
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