SAP Cell and Gene Therapy Orchestration (CGTO) solution helps life sciences companies organize, plan, and execute cell and gene therapy treatments. It covers the orchestration and integrity of the personalized therapy lifecycle and helps ensure that the right patients get the right treatments without errors. CGTO provides the ability to record and track the end-to-end integrity and traceability of the chain of identity (COI) and chain of custody (COC) of custom medicinal products and orchestrate their supply chain to ensure the product is delivered on-time.

 

CGTO is a Software as a Service (SaaS) solution built on SAP BTP - Cloud Foundry platform. It leverages SAP BTP services and is hosted on SAP BTP in the Europe Frankfurt (EU10) region.

 

SOC 1 reports are prepared in accordance with AT-C section 320, Reporting on an Examination of Controls at a Service Organization Relevant to User Entities’ Internal Control Over Financial Reporting, and evaluate the effect of the controls at the service organization on the user entities’ financial statements. SOC 1 reports are specifically intended to meet the needs of the entities that use service organizations (user entities) and the CPAs that audit the user entities’ financial statements (user auditors).  SOC 1 Type 1 report on the fairness of the presentation of management’s description of the service organization’s system and the suitability of the design of controls to achieve the related control objectives as of a specified date, whereas a SOC 1 Type 2 also includes the operating effectiveness of controls to achieve the related control objectives throughout a specified period.

 

SAP Cell and Gene Therapy Orchestration has prepared a SOC 1 Type 1 audit report by an independent 3rd party accountant. This version of the report covers as of 30. September 2023.

 

The use of these reports is restricted to the management of the service organization, user entities, and user auditors. A copy of this report is available for all SAP Cell and Gene Therapy Orchestration customers who had productive and had financially-relevant systems during the audit period covered by the report.