POET is not designed to serve as the system of record for regulated processes, therefore not subject to GxP requirements. It is designed to enable cross-organizational collaboration and process orchestration, while the system of record for each process remains within the respective enterprise systems.

Type = Troubleshooting,; Topic = Multienterprise Information Network Tower (MINT),;Persona = TraceLink Administrator, User,; Orchestration = Manufacturing, Logistics, Commerce, Transportation, Clinical Supply,; Function = Supply Chain, IT, Procurement,

Direct Supplier Incident

Direct supplier incidents are those that occur within suppliers with whom a company has a direct commercial and operational relationship.

What is a direct supplier incident

Direct supplier incidents allow users at companies that own or link to POET (e.g. supplier relationship managers, quality compliance managers, manufacturing plant managers) to collaborate with their internal locations and external Partners to investigate and resolve problems, as well as update processes to ensure an incident does not happen again. For example, a Supplier might need to report a shortage in raw materials to a Manufacturer, or a CMO might need to report a late or missing shipment from the Supplier to the Manufacturer.

Types of direct supplier incidents

  • Quality Issues: Problems with the identity, strength, purity, or labeling of supplied materials that may compromise product quality or patient safety.

  • Deviation Events: Failures to follow established procedures or maintain required process parameters, often due to equipment or environmental factors.

  • Delivery and Logistics Failures: Breakdowns in the timely and accurate supply of materials, impacting production schedules and continuity.

  • Regulatory and Compliance Breaches: Non-conformance with applicable regulations or quality standards, which may result in citations, warnings, or audit failures.

  • Change Control Failures: Unapproved changes to processes, materials, or specifications that can affect quality, compliance, or performance.

  • Performance Issues: Ongoing supplier under-performance that negatively impacts quality, reliability, or service delivery.

  • Data Integrity Issues: Compromises in the accuracy, completeness, or reliability of records that support quality and compliance.

How to use the direct supplier incident marketplace solution

Before configuring and using the direct supplier incident marketplace solution, Solution Designers must first save the latest version of the marketplace solution from the marketplace catalog as a company solution. Once saved, Solution Designers can modify and release them into their Company Catalog. For more information about using marketplace solutions, see OPUS Solution Environment Help Center.

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