To support the orchestration of a CGT treatment order, SAP Cell and Gene Therapy Orchestration provides a rich set of features and capabilities.
These are:
- Order Management
- Task Management
- Exception Management
- Chain of Identity/Chain of Custody Management
- Generation and Printing of Labels
- Manufacturing Management
- Document Management
- Access to Protected Health Information (PHI) Data
- Logistics Management
- Master Data Management
In addition, the following cross-platform features are available:
- Authorization
- E-Signature
- Audit Logging
- Application Logging
- Monitoring
- Change Logging
In Order Management, the Manage Orders app represents the core of the SAP Cell and Gene Therapy Orchestration (CGTO) solution. It orchestrates the path the treatment order request takes after its creation in the patient onboarding or treatment request application (not part of the solution) and its submission to Cell and Gene Therapy Orchestration. This journey is represented as a collection of data and tasks through source systems, such as ERP, until its validation, data completeness, fulfillment, and closing. The integrated Process Flow app gives an overview of the order processing steps along with their statuses. An Order Overview app is also provided, which shows key performance indicators for treatment orders and their processing steps using different visualizations, for example: counts, comparisons, actual versus target, and so on. All other solution components support the overarching order management capabilities.
In addition to the approval and end-to-end management of orders, task management takes care of assigning and orchestrating tasks among the users of the solution and triggering notifications to them. The Manage Tasks app is also integrated into the Manage Orders app, the Manage Shipment app, and the Manage Processing Activity app. This means that the number of open tasks can be seen directly in these apps and the user is directed to the Manage Tasks app to view them.
In the Manage Exceptions app, exceptions which occur during the order processing or other steps within the process are captured and made available for the users to work on a correction, thus ensuring that the treatment order can be executed and managed with an exception. The Manage Exceptions app is also integrated into the Manage Orders app, the Manage Shipment app, and the Manage Processing Activity app, so that the number of open tasks can be seen directly in these apps and the user is directed to the Manage Exceptions app to view the open exceptions.
With the Chain of Custody and Chain of Identity management, SAP Cell and Gene Therapy Orchestration ensures the permanent, unequivocal, and transparent association of a patient's unique identifiers to their biospecimen tissue or cells (raw material), and the resulting drug product. It does so for the entire process from order through manufacturing to treatment and post-treatment monitoring.
It contains the following:
- Generating of Chain of Custody/Chain of Identity IDs
- Collecting and storing Chain of Custody and Chain of Identity events
- Querying events
- Generating Chain of Custody and Chain of Identity reports
Cell and Gene Therapy Orchestration provides label-printing functionality integrating with third-party label management systems. From different apps, users can generate and print labels which will be stored in the document vault.
Manufacturing management provides ability to view/manage all the past/planned and future processing activities. Each processing activity represents different functions such as:
- Label Printing
- Report quality of received samples
- Disposition of Biospecimen and Finished Product
- Report processing start and completion with yield
- Allocation of Manufactured Batches to Shipment
All the GxP relevant steps, such as change of expiry date, manufacturing termination, Chain of Information data update, and so on, are supported by e-signature.
Manufacturing Management enables:
- Viewing of order data
- Label printing
- Capturing of key milestones, for example:
- Goods receipt
- Biospecimen disposition
- Manufacturing milestones
- Product shipment
GxP provides the capability to link documents (which may or may not contain PHI (Protected Health Information) data) to all entities such as treatment orders, shipments and processing activities. From different applications users can view, download and print existing documents from the document vault, as well as upload new documents into the document vault.
Cell and Gene Therapy Orchestration provides authorization-based access from various apps in the solution to patient data stored in customer's PHI (Protected Health Information) Data Vault.
The Manage Shipment app triggers booking request to couriers for the shipment of Biospecimen (BS) and Finished Product (FP) and manages logistics process step handovers.
The following master data management apps are provided for creation of master data within SAP Cell and Gene Therapy Orchestration, which is necessary to run the process.
- CMOs
- Material master
- Business partners
- Carriers
- Therapies
- Flow definitions
Cell and Gene Therapy Orchestration provides platform-wide, reusable services such as:
- Authorization
- E-signature
- Audit logging
- Application logging
- Monitoring
- Change logs