This Help Center is a preview of a future release. The final Help Center will be available on the Validation date.

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,

Document Review

A Document Review allows internal and external stakeholders to collaborate to evaluate and approve documents critical to regulated pharmaceutical processes.

What is document review

Document Review is a formal business process in which internal and external stakeholders collaborate to evaluate and approve documents critical to regulated pharmaceutical processes. These documents may include SOPs, quality agreements, regulatory submissions, validation protocols, and more.

Advantages of document reviews

Compliance: Ensures documents comply with regulatory standards (FDA, EMA, ICH, etc.).
Accuracy: Prevents errors in manufacturing, labeling, or quality processes..
Alignment: Coordinates cross-functional and cross-organizational input.
Auditability: Maintains a traceable history of reviews, decisions, and revisions.
Accountability: Assigns clear responsibility for each review and approval step.

How to use the document review marketplace solution

Before configuring and using the document 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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