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,

Understand Marketplace Solutions

Marketplace Solutions are created by TraceLink or Solution Partners to address specific business needs.

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 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
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	Document Review Batch Record Review	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.
23 Sep 2025	Change Request Manufacturing Incident Direct Supplier Incident Indirect Supplier Incident Product Complaint	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.

Date

Solution

Version

Description

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.

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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