Label and Artwork Review

Solution Designers must first save the latest version of the marketplace solution from the marketplace catalog as a company solution.

1. Select the Main Menu icon.
2. Select OPUS Solution Environment.
3. Select Catalog from the left menu.
4. Select Marketplace Solutions.
5. On the Search Solutions page, filter the list of solutions to find the required solution.
6. Find the latest version of the solution and select the Solution Name to open the solution.
7. On the Solution Details page, select Save As.
8. On the Save As panel, fill in the following fields:
   1. Solution Name field – The name of the solution that will be saved as a company solution.
   2. Description field – (Optional) The description of the solution.
9. Select Apply.
   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.

1. Select the Main Menu icon.
2. Select Administration.
3. Select Network and Apps from the left menu.
4. Select New.
5. In the Network Information section, fill in the following fields:
   1. Application drop-down – Select the application for which you want to configure the marketplace solution. For e.g. Process Orchestration for Empowered Teams.
   2. Network Name field – The name of the network being created.
   3. Network Description field – (Optional) The description of the network being created.
6. In the Solution section, fill in the following fields:
   1. Standard Solution toggle – This value must be no as the solution for which the network is being created is a marketplace solution.
   2. Company Solution field – Select the solution that you saved as a company solution in the previous procedure.
7. Select Save.
   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.

1. Select the Main Menu icon.
2. Select Administration.
3. Select Users from the left menu.
4. Select Network Members from the left menu.
5. On the Search Network Members page, filter the list of network members by the network created in the previous procedure.
6. Select the user email of the user who created the network.
7. Select Edit.
8. In the Roles section, select the role required to access the network.
9. Select Save.
   The role to access the new network is configured.
   

1. Select the Main Menu icon.
2. Select My Networks.
3. Select a [POET Network] from the Select your Network drop-down in the header.
4. Select a Partner or location from the Select your Partner or Location drop-down in the header.
5. Select Go.
6. Select Label and Artwork Reviews from the left menu.
7. Select New.
8. In the General section fill in the following fields:
   1. Title field – The title of the new label and artwork review.
   2. Description field – The description of the label and artwork review.
9. Select Save.
   The label and artwork review is created in the Draft state.
10. To move the label and artwork review to To Do state, select Move to.

1. Select the Main Menu icon.
2. Select My Networks.
3. Select a [POET Network] from the Select your Network drop-down in the header.
4. Select a Partner or location from the Select your Partner or Location drop-down in the header.
5. Select Go.
6. Select Label and Artwork Review from the left menu.
7. Select the Display Identifier of the label and artwork review to edit.
8. Select Edit.
9. In the General section update the following fields:
   1. Display ID field – Unique identifier for a label and artwork review across its lifecycle. The value is system generated.
   2. Title field – The name of the label and artwork review.
   3. Description field – Detailed explanation of why the label or artwork change is required.
   4. Review Type field – Defines the primary reason triggering the review such as Clinical, Localization, Manufacturing, Operational, Packaging, Regulatory, or Other.
   5. Review Reason field – Indicates the origin of the request such as Clinical, Localization, Manufacturing, Operational, Packaging, Regulatory, or Other.
   6. Business Priority field – Indicates the priority of the label and artwork review. Select from Critical, High, Medium, or Low.
   7. Change Control Number field – Reference identifier linking the label and artwork review to a related change control record.
10. Add scheduling details in the Milestones section:
    1. Due Date field – Target date by which the label and artwork review must be completed.
    2. Target Effective Date field – Planned date when the updated label becomes effective.
    3. Submission Deadline field – Deadline for preparing artwork files for regulatory submission.
    4. Print Release Date field – Date when final artwork is released for printing.
11. If collaboration with an external partner is required, enter the following Initiator Company details under the Participants section:
    1. Business Name field – Business name of the company initiating the label and artwork review.
    2. Identifier Type field – Identifier type used to represent the initiating company.
    3. Identifier Value field – Identifier value corresponding to the selected identifier type.
12. If collaboration with an external partner is required, enter the following Assignee Company details under the Participants section:
    1. Business Name field – Business name of the partner company responsible for reviewing the label and artwork.
    2. Identifier Type field – Identifier type used to represent the assignee company.
    3. Identifier Value field – Identifier value corresponding to the selected identifier type.
13. Specify an accountable entity in the Assignee User section:
    1. Email field – Email address of the user assigned to review or take action on the label and artwork review.
    2. Name field – Name of the user responsible for reviewing or approving the label and artwork.
14. Add product details in the Product and Market Scope section:
    1. Product Name field – Commercial or internal name of the pharmaceutical product associated with the label review.
    2. Item Code Type field – Type of unique identifier assigned to the product.
    3. Item Code Value field – Unique identifier value associated with the product.
    4. Product Type field – Indicates the classification of the product such as Prescription Drug, OTC Drug, Medical Device, or Nutritional Product.
    5. Dosage Form field – Physical form in which the product is administered.
    6. Strength field – Strength or concentration of the product.
    7. Impacted Markets field – Countries or regions where the label or artwork update will apply.
15. Add packaging scope details in the Label and Artwork Scope section:
    1. Label Components field – Indicates which packaging components require updates such as Primary Label, Secondary Carton, IFU, Package Insert, Booklet Label, or Blister Foil.
    2. Language Requirement field – Languages required for the updated label or artwork.
    3. Serialization Impact field – Indicates whether serialized data elements are affected.
16. Add details about the artwork files in the Label and Artwork Upload section:
    1. File field – Upload the label or artwork file for review.
    2. Description field – Optional description of the uploaded artwork file.
    3. Original Artwork Location field – URL to the original artwork repository or design location.
    4. Version field – Revision number of the artwork under review.
    5. Uploaded By field – The user who uploaded the artwork file.
    6. Uploaded On field – The date and time when the artwork file was uploaded.
17. Add details about any reference image in the Reference Label and Artworks section:

    1. Reference Label and Artwork Type field - The type of reference artwork.

    2. Reference Label and Artwork File field - The reference artwork file.

18. Add details about the internal review and approval tracking in the Internal Review & Tracking section:
    1. Regulatory Reviewer Email field – Email address of the regulatory reviewer.
    2. Regulatory Reviewer Name field – Name of the regulatory reviewer.
    3. Quality Reviewer Email field – Email address of the quality reviewer.
    4. Quality Reviewer Name field – Name of the quality reviewer.
    5. Quality Approval Status field – Indicates the quality review status. Select from Pending, Approved, or Rejected.
    6. Regulatory Approval Status field – Indicates the regulatory review status. Select from Pending, Approved, or Rejected.
    7. Internal Artwork Approval Status field – Indicates the internal artwork approval state. Select from Not Started, In Review, Changes Requested, Approved, or Rejected.
    8. Approval Date field – The date when final approval for the artwork was granted.
19. Add details about the final outcome in the Closure Details section:
    1. Resolution field – Indicates the final outcome of the label and artwork review.
    2. Closure Reason field – Business explanation for why the review was closed.
    3. Closure Summary field – Summary of how the review concluded.
    4. Closed By field – The user who closed the label and artwork review.
    5. Closed Date field – The date and time when the review was closed.
    6. Approved Artwork field – Final approved artwork file used for downstream execution.
20. Add comments or attachments in the Comments and Attachments section:
    1. Comment Author field – Name of the user who entered the comment.
    2. Last Modified field – Displays the date and time when the comment was last modified.
    3. Comment field – Text of the comment.
    4. Visibility field – Text of the comment.
    5. Attachments field – Name of the file attached.
21. The Followers section displays names of users who are following the label and artwork review:
    1. Followers field – Displays the list of users following the label and artwork review.

1. Select the Main Menu icon.
2. Select My Networks.
3. Select a [POET Network] from the Select your Network drop-down in the header.
4. Select a Partner or location from the Select your Partner or Location drop-down in the header.
5. Select Go.
6. Select Label and Artwork Reviews from the left menu.
7. Select Dashboards.
   View the widgets in the dashboard, which display pre-defined queries to demonstrate the state of all label and artwork reviews at a high level.

1. Select the Main Menu icon.
2. Select My Networks.
3. Select a [POET Network] from the Select your Network drop-down in the header.
4. Select a Partner or location from the Select your Partner or Location drop-down in the header.
5. Select Go.
6. Select Label and Artwork Reviews from the left menu.
7. Select Dashboards.
   View the widgets in the dashboard, which display pre-defined queries to demonstrate the state of all label and artwork reviews at a high level.

1. Select the Main Menu icon.
2. Select My Networks.
3. Select a [POET Network] from the Select your Network drop-down in the header.
4. Select a Partner or location from the Select your Partner or Location drop-down in the header.
5. Select Go.
6. Select Label and Artwork Reviews from the left menu.
7. Select Filter.

8. In the Filters panel, fill in one or more of the following fields to filter the results:

   1. Display ID field – The display identifier of the label and artwork review.
   2. Title field – The title of the label and artwork review.
   3. State field – The state in which the label and artwork review is, such as Draft, To Do, In Progress, or Done.
   4. Creation Time field – The time when the label and artwork review was created.
   5. Initiator Company field – The business name and identifier of the company which initiated the label and artwork review.
   6. Assignee Company field – The business name and identifier of the company which is assigned the label and artwork review.
   7. Due Date field – The due date of the label and artwork review.
   8. Review Type field – The type of label and artwork review.
   9. Business Priority field – The business priority of the label and artwork review.
   10. Last Modified field – The period of time in which the label and artwork review was last updated.

9. Select Apply.
   All label and artwork reviews matching the filter criteria are displayed.