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, Spare 2,
Understand Marketplace Solutions
Marketplace Solutions are created by TraceLink or Solution Partners to address specific business needs. Marketplace solutions in POET are defined as sub-types of the Work Item base object, allowing them to inherit the standard workflow, collaboration, and lifecycle management capabilities.
What is a marketplace solution
Marketplace solutions are created by TraceLink or Solution Partners to address specific business needs. These solutions are published in the OPUS Solution Environment (OSE) catalog, where companies can select, configure, and customize them to fit their own requirements. Once customized, the solutions can be saved as company-specific versions called company solutions that are ready to be used within their business processes. POET currently offers several marketplace solutions, including but not limited to Change Requests, Direct Supplier Incidents, DSCSA Exception Management, Indirect Supplier Incidents, Manufacturing Incidents, and Product Complaint Management.
How to use a 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.
Version History
| Date | Solution | Version | Description |
|---|---|---|---|
| 19 Mar 2026 | 2.1.0 |
The following updates have been made since the previous version was released:
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| 19 Mar 2026 | 1.1.0 |
The following updates have been made since the previous version was released:
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| 19 Mar 2026 | CAPA Exchanges | 1.0.0 | A CAPA exchange is a structured process used to investigate issues, identify root causes, define corrective and preventive actions, and verify their effectiveness. |
| 30 Oct 2025 | Tasks | 1.0.0 |
Tasks or Subtasks in POET facilitate structured orchestration of collaborative workflows where a business outcome is achieved by executing a set of tasks. |
| 29 Oct 2025 | 1.0.0 |
Document Review: Document Review is a business process in which internal and external stakeholders collaborate to evaluate and approve documents critical to regulated pharmaceutical processes. Batch Record Review: Batch Record Review is a regulated quality assurance process where the manufacturing and testing records of a specific batch of a pharmaceutical product are reviewed to ensure compliance with Good Manufacturing Practices (GMP) and regulatory standards (e.g., FDA, EMA) before the batch is released for distribution. |
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| 23 Sep 2025 | 1.0.0 |
Change Request: A change request is a formal proposal to modify an existing process, system, material, document, or equipment. Manufacturing Incident: A manufacturing incident is any unexpected event during production that may impact product quality, safety, compliance, timelines, or supply. Direct Supplier Incident: Direct supplier incidents are those that occur within suppliers with whom a company has a direct commercial and operational relationship. 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. Product Complaint: Product complaint includes issues reported by customers, healthcare providers, distributors, or internal stakeholders about a pharmaceutical product. |
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