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 = Technical Guides,; Topic = Opus Solution Environment, Process Orchestration for Empowered Teams (POET), Opus Platform,;Persona = Solution Designer, Solution Partner, Technology Partner,; Orchestration = Logistics,; Function = Regulatory Affairs, Quality,

Supplier License Reviews

In the pharmaceutical supply chain, a supplier license review is a structured process used to verify that suppliers maintain valid regulatory licenses, certifications, and approvals required for pharmaceutical manufacturing, distribution, or related regulated activities.

What is a supplier license review

A supplier license review ensures that supplier regulatory licenses and certifications remain valid and compliant with regulatory requirements. The supplier license review process typically involves the following steps:

  1. Initiation: A supplier license review is initiated to verify the regulatory standing of a supplier.
  2. Documentation Collection: Regulatory licenses and certifications are collected from the supplier.
  3. Verification: Compliance teams validate the authenticity and validity of submitted licenses.
  4. Assessment: The supplier’s licenses are evaluated against applicable regulatory requirements.
  5. Clarification: After assessing the supplier's licenses, the supplier is requested to provide clarification for any irregularities or discrepancies.
  6. Approval: Compliance or regulatory teams approve the review outcome.

Types of supplier license reviews

  • Manufacturing License Review: Verification of supplier manufacturing authorization licenses.

  • Distribution License Review: Validation of wholesale or distribution licenses.

  • Import and Export License Review: Verification of regulatory permissions required for cross-border product movement.

  • Quality Certification Review: Verification of quality certifications such as GMP or ISO.

  • Regulatory Registration Review: Validation of regulatory registrations applicable to the supplier.

How to configure the supplier license review marketplace solution

Before using the supplier license review marketplace solution, Solution Designers must first configure the solution in Opus Solution Environment (OSE) by completing the following steps:

Add a supplier license review

Modify a supplier license review

Workflow

The workflow defines the lifecycle of a record from creation to completion. Each state represents a stage in the collaboration process between the Owner and Partner organizations.

Workflow State Description
Draft The record is created but not yet shared with external participants. Owners can update information before initiating collaboration.
To Do The record has been shared with participants and is awaiting action from the assigned organization or user.
In Progress The assigned participant is actively working on the task or reviewing the information provided.
Done The workflow has been completed and the record is closed.

Monitor supplier license reviews

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

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