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:
- Initiation: A supplier license review is initiated to verify the regulatory standing of a supplier.
- Documentation Collection: Regulatory licenses and certifications are collected from the supplier.
- Verification: Compliance teams validate the authenticity and validity of submitted licenses.
- Assessment: The supplier’s licenses are evaluated against applicable regulatory requirements.
- Clarification: After assessing the supplier's licenses, the supplier is requested to provide clarification for any irregularities or discrepancies.
- Approval: Compliance or regulatory teams approve the review outcome.
Types of supplier license reviews
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Manufacturing License Review: Verification of supplier manufacturing authorization licenses.
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Distribution License Review: Validation of wholesale or distribution licenses.
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Import and Export License Review: Verification of regulatory permissions required for cross-border product movement.
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Quality Certification Review: Verification of quality certifications such as GMP or ISO.
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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:
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.
Add a supplier license review
- Select the Main Menu
icon. - Select .
- Select a [POET Network] from the drop-down in the header.
- Select a Partner or location from the drop-down in the header.
- Select .
- Select from the left menu.
- Select .
- In the General section fill in the following fields:
- field – The title of the supplier license review.
- field – The description of the supplier license review.
- Select .
The supplier license review is created in the Draft state. - To move the supplier license review to To Do state, select .
Modify a supplier license review
- Select the Main Menu
icon. - Select .
- Select a [POET Network] from the drop-down in the header.
- Select a Partner or location from the drop-down in the header.
- Select .
- Select from the left menu.
- Select the Display Identifier of the review to edit.
- Select .
- Update the following information in the General section:
- field – System-generated ID for the supplier license review.
- field – Supplier License Review title.
- field – Why licenses are requested. Select from Onboarding, Renewal, Expansion, or Regular Audit.
- field – Target completion date for the review.
- field – Additional context or information.
- Update the following information in the Participants section:
- field – Company requesting licenses.
- field – Supplier providing licenses.
- field – Accountable owner for the review.
- Update the following information in the Licenses & Certifications section:
- field – Regulatory-recognized license or certification being reviewed.
- field – Specify the license or certification type if is selected.
- field – Issuing geography, such as country or state.
- field – Issuing authority.
- field – Supplier-provided identifier.
- field – Validity date for the license or certification.
- field – Compliance status. Select from Valid, Invalid, or Under Renewal.
- field – Upload one or more files as license proof.
- field – Additional context.
- If clarification is required for the submitted license information, update the following fields in the Clarification Handling section:
- field – Supplier-provided identifier for the license row requiring clarification.
- field – Reason for requiring the clarification. Select from Missing, Invalid, Expired, Under Renewal, or Others.
- field – Clarification request sent to the supplier.
- field – Requester details.
- field – Supplier explanation.
- field – Target resolution date.
- field – Responder details.
- Update the following information in the Compliance Review Summary section:
- field – Overall compliance decision. Select from Compliant, Partially Compliant, or Non-Compliant.
- field – Compliance comments.
- field – Review completion date.
- field – Indicates whether there was a prior audit failure.
- field – Reviewer details.
- Update the following information in the Closure Summary section:
- field – Final closure outcome. Select from Closed-Compliant, Closed-With Exceptions, Closed-With Conditions, Closed-Non-Compliant, or Closed-Re-review Required.
- field – Closure rationale.
- field – Formal closure date.
- field – User who closed the supplier license review.
- Add comments in the Comments and Attachments section.
- field – User who entered the comment.
- field – Comment content.
- field – Supporting CAPA documentation.
- Review the Followers section to view the list of users following the Supplier License Review record.
- Select .
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.
- Select the Main Menu
icon. - Select .
- Select a [POET Network] from the drop-down in the header.
- Select a Partner or location from the drop-down in the header.
- Select .
- Select .
- Select .
| Metric | Description |
|---|---|
| Current Trends | |
| Supplier License Reviews by Status – Open | Total number of Supplier License Reviews records categorized by currentState (Draft, To Do, In Progress). Provides real-time visibility into license coordination lifecycle distribution and bottlenecks. |
| Supplier License Reviews by Business Priority | Total number of Supplier License Reviews records by priority by currentState (Draft, To Do, In Progress). Enables compliance tracking by business urgency. |
| Open Supplier License Reviews by License Status | Open Supplier License Reviews categorized by License Status (Valid, Invalid, Under Renewal) by currentState. Identifies compliance exposure and renewal risk. |
| Supplier License Reviews by License Type | Distribution by License Type (GMP, GDP, Wholesaler, Import, Export, Controlled Substance, etc.) by currentState. Identifies high-volume regulatory domains and exposure areas. |
| Due Date Monitoring | |
| Overdue Supplier License Reviews | Supplier License Reviews records past Due Date by currentState. Escalates compliance and license lapse risks. |
| Due in Next 24 Hours | Supplier License Reviews records due within 24 hours by currentState. Indicates reviews requiring immediate compliance attention. |
| Due in Next 7 Days | Supplier License Reviews records due within 7 days by currentState. Supports short-term workload and renewal planning. |
| Due in Future | Supplier License Reviews records due beyond 7 days by currentState. Supports compliance capacity forecasting. |
| Network Performance | |
| Supplier License Reviews by Partner | Supplier License Reviews grouped by Supplier Company stacked by currentState (Draft, To Do, In Progress). Identifies supplier-specific compliance risk and coordination workload. |
| Supplier License Reviews by Jurisdiction | Supplier License Reviews categorized by Jurisdiction by currentState. Tracks geographic regulatory exposure. |
| Clarification Rate | Percentage of Supplier License Reviews entering the Clarification Required sub-state. Identifies documentation gaps and supplier responsiveness issues. |
| Organizational Performance | |
| Supplier License Reviews by Compliance Owner | Distribution of Supplier License Reviews by Compliance Owner. Enables workload balancing and accountability. |
| Supplier License Reviews by Closure Outcome | Closed Supplier License Reviews categorized by Closure Status (Closed Compliant, Closed With Conditions, Closed Non Compliant). Measures supplier compliance quality. |
| Average Time to Close Supplier License Reviews | Average duration from creation to Done state. Measures license coordination efficiency. |
| On-Time Closure Rate | Percentage of Supplier License Reviews closed before Due Date. Tracks compliance SLA adherence. |
Steps to access
- Select the Main Menu
icon. - Select .
- Select a [POET Network] from the drop-down in the header.
- Select a Partner or location from the drop-down in the header.
- Select .
- Select .
- Select .
| Metric | Description |
|---|---|
| Current Trends | |
| Supplier License Reviews by Status – Open | Supplier License Reviews categorized by currentState (Draft, To Do, In Progress). Provides visibility into active license coordination tasks. |
| Supplier License Reviews by Business Priority | Total number of Supplier License Reviews by priority by currentState. Enables prioritization of compliance-critical submissions. |
| Supplier License Reviews by License Status | Open Supplier License Reviews categorized by License Status. Identifies renewal and invalid documentation risk. |
| Supplier License Reviews by License Type | Distribution of license types assigned to the partner organization. Highlights regulatory scope and exposure. |
| Due Date Monitoring | |
| Overdue Supplier License Reviews | Supplier License Reviews past Due Date by currentState. Escalates partner compliance delays. |
| Due in Next 24 Hours | Supplier License Reviews due within the next 24 hours. Indicates urgent compliance actions. |
| Due in Next 7 Days | Supplier License Reviews due within the next 7 days. Supports short-term workload planning. |
| Due in Future | Supplier License Reviews due in future. Provides planning visibility for compliance activities. |
| Network Performance | |
| Supplier License Reviews Failed Prior by Partner | Supplier License Reviews grouped by partners where reviews failed. Identifies site-specific compliance exposure. |
| Supplier License Reviews by Jurisdiction | Supplier License Reviews categorized by Jurisdiction. Tracks regulatory obligations by region. |
| Organizational Performance | |
| Average Time to Close Partner-Owned Supplier License Reviews | Average closure duration for partner-owned supplier license reviews. Measures partner responsiveness. |
| Supplier License Reviews by Closure Outcome (My Organization) | Closed Supplier License Reviews categorized by Closure Status. Reflects documentation readiness and compliance maturity. |
- Select the Main Menu
icon. - Select .
- Select a [POET Network] from the drop-down in the header.
- Select a Partner or location from the drop-down in the header.
- Select .
- Select from the left menu.
- Select .
-
In the Filters panel, fill in one or more of the following fields to filter the results:
- field – Search by display identifier.
- field – Supports partial or full text search.
- field – Filter by workflow state such as Draft, To Do, In Progress, or Done.
- field – Search by SLC creation timestamp.
- field – Search by the initiating company.
- field – Search by the supplier company.
- field – Search by the assigned compliance owner.
- field – Filter by the target due date.
- field – Filter by request reason such as Onboarding, Renewal, Expansion, or Audit.
- field – Filter by compliance assessment such as Compliant, Partially Compliant, or Non-Compliant.
- field – Search by last updated timestamp.
-
Select .
All supplier license reviews matching the filter criteria are displayed.
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