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,;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.
Add a supplier license review
Add an SOP evaluation by entering the required details.
- 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
Modify an existing supplier license review by updating the required details.
- 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
Monitor supplier license review records using dashboards and search to track progress, monitor key activities, and analyze performance.
- 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.
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Select .
All supplier license reviews matching the filter criteria are displayed.
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