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,

Indirect Supplier Incident

Indirect supplier incidents originate from suppliers you do not contract with directly, but who provide materials or services to your direct suppliers.

What is a indirect supplier incident

Indirect supplier incidents arise from suppliers without a direct contractual relationship, but who provide materials or services to a company’s direct suppliers. For e.g. raw material contamination, process changes, regulatory or legal action, or supply chain disruption.

Types of indirect supplier incidents

  • Raw Material Contamination: Introduction of adulterated, counterfeit, or unsafe raw materials that compromise product safety and quality.

  • Process Changes at Tier-2: Unapproved modifications to raw material synthesis, formulation, or processing methods that introduce risks to quality or safety.

  • Regulatory or Legal Action at Tier-2: Actions by regulatory or legal authorities against a Tier-2 supplier that disrupt availability, compliance, or certification status.

  • Supply Chain Disruption: Interruptions in the flow of materials due to external events beyond the supplier’s direct control, impacting continuity and timelines.

How to use the indirect supplier incident marketplace solution

Before configuring and using the indirect supplier incidents 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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