SOP Evaluations

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 SOP Evaluations from the left menu.
7. Select New.
8. In the General section fill in the following fields:
   1. Title field – Title describing the SOP Evaluation.
   2. Description field – Description of the evaluation, including context and supporting details.
9. Select Save.
   The SOP Evaluation is created in the Draft state.
10. To move the SOP Evaluation 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 SOP Evaluations from the left menu.
7. Select the Display Identifier of the SOP Evaluation 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 SOP Evaluation.
   3. SOP Document Name field - The standard name of the SOP document under evaluation.
   4. Related SOP field - Reference of the SOP that is being created or updated.
   5. SOP Version field - The current or target version of the SOP under evaluation.
   6. Evaluation Type field - Select whether the evaluation is for a new SOP, major update, or minor update.
   7. Regulated Area field - Select the accountable regulated area for the SOP Evaluation.
   8. Functional Area field - Select the functional area associated with the selected regulated area.
   9. Business Priority field - Select the urgency level for the SOP Evaluation.
   10. Description field - Additional information for the evaluation request.

10. In the Participants section update the following fields:

    1. Initiator Company Business Name field - Business name of the company initiating the SOP evaluation.
    2. Initiator Company Identifier Type field - Identifier type used to represent the initiating company.
    3. Initiator Company Identifier Value field - Identifier value corresponding to the selected identifier type.
    4. Assignee Company Business Name field - Business name of the partner company responsible for reviewing the SOP evaluation.
    5. Assignee Company Identifier Type field - Identifier type used to represent the assignee company.
    6. Assignee Company Identifier Value field - Identifier value corresponding to the selected identifier type.
    7. Assignee User Email field - Email address of the user assigned to review or take action on the SOP evaluation.
    8. Assignee User Name field - Name of the user responsible for reviewing or approving the SOP evaluation.
    9. SOP Owner Email field - Email address of the owner of the SOP evaluation.
    10. SOP Owner Name field - Name of the owner of the SOP evaluation.
    11. SME Lead Email field - Displays the email address of the subject matter expert lead.
    12. SME Lead Name field - Displays the name of the subject matter expert lead.

11. In the Scope & Objectives section update the following fields:

    1. Evaluation Objective field - Define the intended outcome of the SOP Evaluation.
    2. Scope Definition field - Describe what is included in the SOP Evaluation.
    3. Out of Scope field - Clarify what will not be addressed as part of the SOP Evaluation.
    4. Success Criteria field - Define the measurable criteria for successful evaluation.
    5. Regulatory Impact field - Indicate whether there is a regulatory driver or impact.
    6. Risk Assessment Summary field - Summarize key risks and mitigations related to the SOP Evaluation.

12. In the Under Development section update the following fields:

    1. Draft Summary field - Provide a summary of the SOP draft or proposed changes.
    2. Version Notes field - Provide a high-level description of the changes introduced.
    3. Supporting Documents field - Upload supporting documentation for the SOP Evaluation.

13. In the Review & Testing section add a new review or link an existing review.

    1. To add a review to the SOP Evaluation, select Add Review and Testing.
       1. Business Object type field - Select Review and Testing as the Business Object Type.
       2. Title field - Enter the title of the review and testing.
       3. Due Date field - Enter the date by which the review and testing must be completed.
    2. To link an existing review, select in the Review and Testing section.
       1. Review and Testing drop-down - Select the Review and Testing that must be linked to the SOP Evaluation.
       2. Title field - The title will be auto-populated.
       3. Due Date field - The due date will be auto-populated.
    To add a review from the Review and Testing page and then link it to the SOP Evaluation, see Add Review and Testing.

14. In the Under Revision section update the following fields:

    1. Revision Cycle field - Displays the revision cycle number for the revision activity.
    2. Conflict Type field - Select the type of issue requiring revision.
    3. Date Raised field - Enter the date the revision item was raised.
    4. Overall Identified Gap field - Describe the issue, gap, conflict, or deficiency identified during review.
    5. Resolution Description field - Describe how the identified issue will be addressed.
    6. Verified By field - Select the person who confirmed that the revision resolves the issue.
    7. Supporting Document field - Upload the updated SOP document or related supporting document.

15. In the Approval & Implementation section update the following fields:

    1. Approval Status field - Select whether the SOP Evaluation is approved or rejected.
    2. Approval/Rejection Date field - Enter the date of SOP acceptance or rejection.
    3. Approved/Rejected By field - Select the user responsible for verifying and signing off on the SOP.
    4. Rollout Plan Summary field - Describe the rollout and communication approach.
    5. Implementation Date field - Enter the effective date of SOP implementation.
    6. Implementation Lead field - Select the user responsible for rollout.
    7. Training Required field - Indicate whether training is required.
    8. Training Due Date field - Enter the training due date when training is required.

16. In the Alignment Outcome section update the following fields:

    1. SOP Evaluation Status field - Select the final outcome status for the SOP Evaluation.
    2. Next Review Date field - Enter the date for the next formal review cycle.
    3. Closed By field - Displays the user who closed the SOP Evaluation during transition to Done.
    4. Closed Date field - Displays the date and time the SOP Evaluation was closed during transition to Done.

17. In the Comments and Attachments section review the following fields:

    1. Comment Author field - Displays the user who entered the comment.
    2. Last Modified field - Displays the date and time the comment was last updated.
    3. Comment Text field - Displays the body of the comment.
    4. Attachments field - Displays files attached to the comment.

18. In the Followers section review the following fields:

    1. Follower field - Displays the list of users following the SOP Evaluation.

19. Select Save.

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 Review and Testing from the left menu.
7. Select the Display Identifier of the Review and Testing to edit.
8. Select Edit Review & Testing Details.

9. In the General section update the following fields:

   1. Display Identifier field - Displays the identifier of the Review and Testing work item.
   2. Title field - The name or title of the Review and Testing work item.
   3. Planned Start Date field - Date the department started review and testing.
   4. Planned End Date field - Date the department plans to complete review and testing.
   5. Due Date field - Deadline for Review and Testing.
   6. SOP Document Name field - Name of the SOP document being reviewed or tested.
   7. SOP Version field - Indicates the version of the SOP being reviewed or tested.
   8. Review Cycle Number field - Indicates the review round this work item belongs to.
   9. Business Priority field - Defines the urgency level for this review and testing activity.
   10. List Identifier field - Links the work item to its list.
   11. Description field - Detailed description of the review and testing activity.

10. In the Participants section update the following fields:

    1. Initiator Company Business Name field - Business name of the initiator company.
    2. Initiator Company Identifier Type field - Identifier type of the initiating company.
    3. Initiator Company Identifier Value field - Value of the initiator company identifier.
    4. Assignee Company Business Name field - Business name of the assignee company.
    5. Assignee Company Identifier Type field - Identifier type of the assignee company.
    6. Assignee Company Identifier Value field - Value of the assignee company identifier.
    7. Assignee User Email field - Email address of the person to whom the Review and Testing is currently assigned.
    8. Assignee User Name field - Name of the person to whom the Review and Testing is currently assigned.

11. In the Ready for Review section update the following fields:

    1. Reviewing Team field - Select the team responsible for performing the review and testing activity.
    2. Reviewer field - Select the assigned reviewer responsible for completing the review and testing activity.
    3. Review Type field - Select the reason for this review and testing activity.
    4. Testing Required field - Select whether testing, walkthrough, simulation, or validation is required.
    5. Testing Method field - Select the method used for testing or validation.
    6. Other Testing Method field - Enter the testing method when Other is selected.
    7. Acceptance Criteria field - Describe the expected outcome for the review and testing activity.

12. In the In Review & Testing section update the following fields:

    1. Testing Results field - Capture testing, walkthrough, simulation, or validation results.
    2. Review Feedback field - Provide consolidated feedback from the reviewing team.
    3. Acceptance Criteria Met field - Indicate whether the defined acceptance criteria were satisfied during review and testing.
    4. Revision Required field - Select whether this team requires SOP revision.
    5. Supporting Document field - Upload supporting documentation for the review and testing activity.

13. In the Review and Testing Outcome section update the following fields when revision is required:

    1. Revision Justification field - Provide a detailed explanation of why the revision is required and what is being addressed.
    2. Identified Gaps field - List issues, gaps, discrepancies, or concerns identified during review and testing.
    3. Severity of Findings field - Select the level of risk associated with the review findings.
    4. Impact Areas field - Select the business or process areas impacted by the findings that require SOP revision.
    5. Supporting Document field - Upload supporting documentation.
    6. Resolution field - Select the final resolution of the review and testing activity.
    7. Closure Comments field - Enter the summary or rationale supporting the resolution.
    8. Closed By field - Displays the user who completed and finalized the review and testing activity.
    9. Closed Date field - Displays the date when the review and testing activity was officially closed.

14. In the Review and Testing Outcome section update the following fields when revision is not required:

    1. Resolution field - Select the final resolution of the review and testing activity.
    2. Closure Comments field - Enter the summary or rationale supporting the resolution.
    3. Closed By field - Displays the user who completed and finalized the review and testing activity.
    4. Closed Date field - Displays the date when the review and testing activity was officially closed.

15. In the Comments and Attachments section review the following fields:

    1. Comment Author field - Displays the user who entered the comment.
    2. Last Modified field - Displays the date and time when the comment was last modified.
    3. Comment Text field - Displays the text of the comment.
    4. Attachments field - Displays files attached to the comment.

16. In the Followers section review the following fields:

    1. Followers field - Displays the list of users who follow the Review and Testing work item.

17. Select Save.

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 SOP Evaluations.
7. Select Dashboards.

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 SOP Evaluations 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 Identifier field – Display Identifier of the SOP Evaluations can be used for search.
   2. Title field – Allows the user to search with complete or part of the title string.
   3. State field – Workflow state of the SOP Evaluations such as Draft, To Do, In Progress, or Done.
   4. Creation Time field – The timestamp when the SOP Evaluations was created.
   5. SOP Document Name field – Standard name of the SOP document under Evaluations.
   6. SOP Version field – Version of the SOP under Evaluations.
   7. Evaluations Type field – Indicates the nature of the Evaluations effort such as New SOP, Major Update, or Minor Update.
   8. Regulated Area field – Select the accountable area such as GMP – Manufacturing, GMP – Quality Systems, GMP – Facilities & Engineering, GDP – Distribution, GCP – Clinical, GVP – Pharmacovigilance, R&D / Technical, or Corporate Quality & Compliance.
   9. Due Date field – The due date for the SOP Evaluations.
   10. Priority field – Allows the user to search with the Priority.
   11. Last Modified field – The timestamp when the SOP Evaluations was last modified.

9. Select Apply.
   All SOP Evaluations matching the filter criteria are displayed.

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 Review & Testing.
7. Select Dashboards.

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 Review & Testing.
7. Select Dashboards.

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 Review and Testing 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 Identifier field – Display identifier of the Review and Testing work item.
   2. Title field – Complete or partial title of the Review and Testing work item.
   3. State field – Workflow state of the Review and Testing work item such as Draft, Ready for Review, In Review & Testing, Review Completed, or Cancelled.
   4. Creation Time field – The timestamp when the Review and Testing work item was created.
   5. Initiator Company field – The business name and identifier of the company that initiated the Review and Testing work item.
   6. Assignee Company field – The business name and identifier of the company assigned to the Review and Testing work item.
   7. Due Date field – The due date of the Review and Testing work item.
   8. Business Priority field – Priority of the Review and Testing work item such as Critical, High, Medium, or Low.
   9. Reviewing Team field – The reviewing team assigned to the Review and Testing work item.
   10. Resolution field – Review outcome such as No Revision Required or Revision Required.
   11. Last Modified field – The timestamp when the Review and Testing work item was last modified.

9. Select Apply.
   All Review and Testing work items matching the filter criteria are displayed.