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,

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 configure the document review marketplace solution

Before using the document review marketplace solution, Solution Designers must first configure the solution in Opus Solution Environment (OSE) by following the steps listed below:

For more information about configuring or customizing marketplace solutions as per your business needs, see OPUS Solution Environment Help Center.

Add a document review

Modify a document review

Document reviews workflow

The following workflow states are used to track the progress of a document review:

Base State Workflow State Description
Draft Draft The document review task is being created or prepared and has not yet been submitted for review.
To Do Ready for Review The document has been submitted by the author and is ready for reviewers to begin the review process.
In Progress Under Review The document is actively being reviewed, and reviewers are providing feedback, comments, or approvals.
Done Completed The document review has been finalized, and the document has been approved, closed, or recorded as reviewed.

Monitor document reviews

A high level understanding of the state of all document reviews that you have access to.

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