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 = Fundamentals,; Topic = OPUS Solution Environment, Process Orchestration for Empowered Teams (POET),;Persona = Solution Designer,; Orchestration =; Function = Supply Chain,
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.
How to configure a marketplace solution
Before using a marketplace solution, configure the solution in OPUS Solution Environment.
Solution Designers must first save the latest version of the marketplace solution from the marketplace catalog as a company solution.
- Select the Main Menu
icon. - Select .
- Select from the left menu.
- Select .
- On the Search Solutions page, filter the list of solutions to find the required solution.
- Find the latest version of the solution and select the to open the solution.
- On the Solution Details page, select .
- On the Save As panel, fill in the following fields:
- field – The name of the solution that will be saved as a company solution.
- field – (Optional) The description of the solution.
- Select .
The marketplace will be saved as a company solution in the Available tab on the left menu.
After saving the solution as a Company Solution, Solution designers must create a network for the solution from OPUS Administration.
- Select the Main Menu
icon. - Select .
- Select from the left menu.
- Select .
- In the Network Information section, fill in the following fields:
- drop-down – Select the application for which you want to configure the marketplace solution. For e.g. Process Orchestration for Empowered Teams.
- field – The name of the network being created.
- field – (Optional) The description of the network being created.
- In the Solution section, fill in the following fields:
- toggle – This value must be no as the solution for which the network is being created is a marketplace solution.
- field – Select the solution that you saved as a company solution in the previous procedure.
- Select .
The new network is created and the solution is ready for use.
After creating a network for the solution, Solution Designers must define roles for accessing the network.
- Select the Main Menu
icon. - Select .
- Select from the left menu.
- Select from the left menu.
- On the Search Network Members page, filter the list of network members by the network created in the previous procedure.
- Select the user email of the user who created the network.
- Select .
- In the Roles section, select the role required to access the network.
- Select .
The role to access the new network is configured.
Version History
| Date | Solution | Version | Description |
|---|---|---|---|
| 19 Aug 2026 |
Material Specification Evaluation
|
1.0.1 |
Material specification evaluation provides a structured approach for confirming that a proposed supplier or source can meet an approved material specification. It enables owners and suppliers to collaborate on feasibility, supporting documentation, technical evidence, gap resolution, and approval decisions, helping ensure qualified material sources, clear traceability, and stronger audit readiness. |
| 19 Aug 2026 | 1.0.0 |
Transportation and route risk assessment provides a structured approach for identifying and managing risks across pharmaceutical transportation lanes. It enables product owners and logistics partners to jointly assess route, temperature, security, regulatory, and operational risks, establish appropriate controls, validate lanes, manage shipment exceptions, and continuously review performance. The process supports product quality, patient safety, GDP compliance, and reliable supply chain operations. |
|
| 24 Jul 2026 | DSCSA Exception Management | 2.2.0M1 | Enhanced the POET_CECommentEmlToJson transform to automatically remove hidden Microsoft Office formatting metadata while preserving the visible comment content, including text formatting, hyperlinks, and lists. |
| 07 Jul 2026 | SOP Evaluations | 1.0.0 | SOP Evaluation is a documented process used to assess, align, review, and approve a Standard Operating Procedure (SOP) so it supports standardized work practices and compliance requirements. |
| 30 Jun 2026 | 1.0.0 |
Label and Artwork Review Label and Artwork Review is the process of reviewing and approving product labels and packaging artwork. Operator Certification Tracking Operator Certification Tracking helps organizations monitor, manage, and document operator certifications, qualifications, and training evidence so operators are authorized to perform specific tasks or use specific equipment. Site Readiness Assessment Site Readiness Assessments enable pharmaceutical companies to initiate and manage structured readiness inspections or assessments for internal and external supply chain sites. Supplier Performance Assessment Supplier Performance Assessment enables organizations to initiate, evaluate, review, and close structured supplier performance assessments across their supply network. |
|
| 30 Jun 2026 | DSCSA Exception Management | 2.2.0 |
The following updates have been made since the previous version was released:
|
| 29 Apr 2026 | 1.0.0 |
Audits and Inspections - Audits and inspections help plan, execute, and close regulatory inspections and third-party audits across the pharmaceutical supply chain. Supplier License Review - Supplier License Review helps collect, verify, and maintain regulatory licenses and certifications for suppliers in the pharmaceutical supply chain. Supplier Risk Assessment - Supplier Risk Assessment helps evaluate, classify, and manage suppliers based on the risks they introduce to the business. |
|
| 19 Mar 2026 | 2.1.0 |
The following updates have been made since the previous version was released:
|
|
| 19 Mar 2026 | 1.1.0 |
The following updates have been made since the previous version was released:
|
|
| 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. |
|
| 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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