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 remains within 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,
Material Specification Evaluations
Material Specification Evaluations enables Owner and Supplier organizations to collaboratively evaluate and approve a material-source combination against an approved material specification before the material is authorized for GMP supply.
What is a material specification evaluation
A material specification evaluation is an end-to-end collaborative process for exchanging technical information, validating material capability, reviewing supporting evidence, and recording the final qualification outcome for a specific material-source combination.
Types of material specification evaluations
- New Material
- Initial Qualification
- Material Revision
- Specification Change
- New Supplier
- Alternate Supplier
- Alternate Source Qualification
- Supplier Change
- Supplier Site Change
- Manufacturing Site Change
- Material Source Change
- New Grade Qualification
- Requalification
- Periodic Review
- Regulatory Change
- Compendial Update
- Analytical Method Change
- Quality Event
- Business Continuity
- Supply Risk Mitigation
- Shortage / Supply Constraint
- Process Improvement
- Cost Reduction
- Material Retirement / Discontinuation
Add a material specification evaluation
Add a material specification 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 – Enter a title for the material specification evaluation. This field is required.
- field – Enter a description or additional context for the material specification evaluation.
- Select .
The material specification evaluation is created in Draft state. - Select to progress the evaluation.
Modify a material specification evaluation
Modify an existing material specification evaluation 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 required material specification evaluation.
- Select .
- In the General section update the following fields:
- field – Enter the descriptive title of the material specification evaluation.
- field – Enter the summary of the evaluation.
- field – Select the reason for initiating the material specification evaluation.
- field– Select the product domain applicable to the evaluation.
- field – Enter the product or products for which the material qualification applies.
- field – Select Critical, High, Medium, or Low.
- – Specify the target completion date.
- In the Participants section update the following fields:
- field – Review or update the initiating company information, including Business Name, Identifier Type, and Identifier Value.
- field – Review or update the assigned company information, including Business Name, Identifier Type, and Identifier Value.
- field – Review or update the assigned user's Email and Name.
- In the Material Information section update the following fields:
- field – Enter the material name.
- field – Enter the ERP or material master identifier.
- field – Select the classification of the material.
- field – Select the applicable material type based on the Material Category.
- field – Select the grade of the material being qualified.
- field – Enter additional material grade details.
- field – Identify the site or sites where the material will be used.
- field – Select the GMP relevance of the material-source combination.
- In the Specification Details section update the following fields:
- field – Enter the name of the approved material specification against which supplier evidence will be assessed.
- field – Enter the version of the approved material specification.
- field – Upload the approved material specification document.
- field – Identify the person or function responsible for the approved specification.
- field – Enter additional information relevant to the approved specification.
- In the Specification Review section update the following fields:
- field – Enter a summary of the supplier's review of the evaluation request.
- field – Select Feasible, Feasible with Conditions, or Not Feasible.
- In the Material Availability and Manufacturing Capability section update the following fields:
- field – Indicate whether the proposed material is available.
- field – Enter the site name or location where the material is manufactured.
- field – Indicate whether manufacturing capability is confirmed.
- field – Enter supplier comments about availability, lead time, constraints, and manufacturing capability.
- In the Specification Validation section update the following fields:
- field – Indicate whether the supplier considers the material aligned with the approved specification.
- field – Enter a summary of supplier validation activities and any differences between supplier capability or results and the approved specification.
- In the Review and Validation Documents section update the following fields:
- field – Select the type of supporting technical, quality, regulatory, validation, or supplier document.
- field – Upload the supporting document.
- field – Enter additional comments regarding the submitted evidence.
- In the Supplier Submission Review section update the following fields:
- field – Enter the Owner's overall assessment of the submitted evidence.
- field – Indicate whether the review is complete.
- field – Enter Owner observations and comments supporting the review outcome.
- In the Supplier Submission Validation section update the following fields:
- field – Upload laboratory results, qualification sample reports, comparability studies, or internal validation reports used to support the qualification decision.
- field – Indicate whether validation is complete.
- In the Additional Documents section update the following fields:
- field – Upload additional documents that support the Owner's findings after review and validation.
- In the Closure Summary section update the following fields:
- field – Select Approved, Approved with Conditions, Rejected, or Canceled.
- field – Enter a summary supporting the approval decision.
- field – Specify the date from which the approval becomes effective.
- field – Enter a summary of the completed evaluation.
- field – Identify the user closing the evaluation record.
- field – Specify the date the evaluation record was closed.
- Select .
Monitor material specification evaluations
Monitor material specification evaluations using the Owner dashboard, Partner dashboard, and Search.
- 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 .
| Metric | Description |
|---|---|
| Current Trends | |
| Material Specification Evaluations by Status – Open | Total number of Material Specification Evaluations categorized by Status (Draft, To Do, In Progress). |
| Material Specification Evaluations by Business Priority | Total number of open Material Specification Evaluations categorized by Business Priority (Critical, High, Medium, Low). |
| Material Specification Evaluations by Evaluation Reason | Total number of open Material Specification Evaluations categorized by Evaluation Reason, such as New Material, Initial Qualification, Material Revision, and Specification Change. |
| Material Specification Evaluations by Product Type | Total number of open Material Specification Evaluations categorized by Product Type, such as Small Molecule, Biologics, Cell and Gene Therapy, and Vaccines. |
| Material Specification Evaluations by Material Category | Total number of open Material Specification Evaluations categorized by Material Category, including Chemical and Process Materials, Biological Materials, Manufacturing Components, Packaging Components, Quality Control Materials, and Utilities. |
| Due Date Monitoring | |
| Material Specification Evaluations Due in Next 24 Hours | Total number of Material Specification Evaluations with Due Date within the next 24 hours categorized by Status (Draft, To Do, In Progress). |
| Material Specification Evaluations Due in Next 7 Days | Total number of Material Specification Evaluations with Due Date within the next 7 days categorized by Status (Draft, To Do, In Progress). |
| Material Specification Evaluations Overdue | Total number of Material Specification Evaluations with Due Date earlier than the current date and time categorized by Status (Draft, To Do, In Progress). |
| Material Specification Evaluations Due in Future | Total number of Material Specification Evaluations with Due Date greater than or equal to the current date and time categorized by Status (Draft, To Do, In Progress). |
| Network Performance | |
| Material Specification Evaluations by Assignee Company | Total number of open Material Specification Evaluations categorized by Assignee Company. |
| Material Specification Evaluations by Assignee User | Total number of open Material Specification Evaluations categorized by Assignee User. |
| Supplier Feasibility by Assignee Company | Total number of Material Specification Evaluations for each Assignee Company categorized by Feasibility (Feasible, Feasible with Conditions, Not Feasible). |
| Manufacturing Capability Confirmed by Assignee Company | Total number of Material Specification Evaluations for each Assignee Company categorized by Manufacturing Capability. |
| Organizational Performance | |
| Material Specification Evaluations by Overall Outcome | Total number of Material Specification Evaluations in Done state categorized by Overall Outcome (Approved, Approved with Conditions, Rejected, Canceled). |
| Average Time to Close Material Specification Evaluation by Overall Outcome | Average time taken to close Material Specification Evaluations categorized by Overall Outcome (Approved, Approved with Conditions, Rejected, Canceled). |
- 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 .
| Metric | Description |
|---|---|
| Current Trends | |
| Material Specification Evaluations by Status – Open | Total number of Material Specification Evaluations categorized by Status (Draft, To Do, In Progress). |
| Material Specification Evaluations by Business Priority | Total number of open Material Specification Evaluations categorized by Business Priority (Critical, High, Medium, Low). |
| Material Specification Evaluations by Evaluation Reason | Total number of open Material Specification Evaluations categorized by Evaluation Reason, such as New Material, Initial Qualification, Material Revision, and Specification Change. |
| Material Specification Evaluations by Product Type | Total number of open Material Specification Evaluations categorized by Product Type, such as Small Molecule, Biologics, Cell and Gene Therapy, and Vaccines. |
| Material Specification Evaluations by Material Category | Total number of open Material Specification Evaluations categorized by Material Category, including Chemical and Process Materials, Biological Materials, Manufacturing Components, Packaging Components, Quality Control Materials, and Utilities. |
| Due Date Monitoring | |
| Material Specification Evaluations Due in Next 24 Hours | Total number of Material Specification Evaluations with Due Date within the next 24 hours categorized by Status (Draft, To Do, In Progress). |
| Material Specification Evaluations Due in Next 7 Days | Total number of Material Specification Evaluations with Due Date within the next 7 days categorized by Status (Draft, To Do, In Progress). |
| Material Specification Evaluations Overdue | Total number of Material Specification Evaluations with Due Date earlier than the current date and time categorized by Status (Draft, To Do, In Progress). |
| Material Specification Evaluations Due in Future | Total number of Material Specification Evaluations with Due Date greater than or equal to the current date and time categorized by Status (Draft, To Do, In Progress). |
| Network Performance | |
| Material Specification Evaluations by Feasibility | Total number of Material Specification Evaluations categorized by Feasibility (Feasible, Feasible with Conditions, Not Feasible). |
| Material Specification Evaluations by Material Availability | Total number of Material Specification Evaluations categorized by Material Availability. |
| Material Specification Evaluations by Manufacturing Capability | Total number of Material Specification Evaluations categorized by Manufacturing Capability. |
| Organizational Performance | |
| Material Specification Evaluations by Overall Outcome | Total number of Material Specification Evaluations in Done state categorized by Overall Outcome (Approved, Approved with Conditions, Rejected, Canceled). |
| Average Time to Close Material Specification Evaluation by Overall Outcome | Average time taken to close Material Specification Evaluations categorized by Overall Outcome (Approved, Approved with Conditions, Rejected, Canceled). |
- 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 one or more of the following fields:
- field – Enter the Material Specification Evaluation display identifier to search for.
- field – Enter the complete or partial title to search for.
- field – Filter by the current state. Base states are Draft, To Do, In Progress, and Done; configured substates are also available through currentState.
- field – Search by the timestamp when the Material Specification Evaluation was created.
- field – Search by initiating company business name or identifier.
- field – Search by assignee company business name or identifier.
- field – Filter by the target completion date.
- field – Filter by the reason the evaluation was initiated.
- field – Enter the material name to search for.
- field – Enter the Owner material identifier to search for.
- field – Filter by Business Priority.
- field – Search by the timestamp when the Material Specification Evaluation was last modified.
- Select .
Matching material specification evaluations are displayed.
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