Enable PSMF Automatic Logbook Generation

With the 22R3 release, SafetyDocs can generate a Pharmacovigilance System Master File (PSMF) logbook when merging a PSMF Binder to a PDF. Vault populates the logbook based on the PSMF Logbook Entries for each major version of a PSMF document in the PSMF Binder.

26R1 Updates

With the 26R1 release, we have added the following updates to this feature:

  • PSMF: Display Document Title in PDF Table of Contents: SafetyDocs introduces the ability to display document Titles, instead of Names, in PSMF Table of Contents. To configure your Vault for this feature, update the PSMF Table of Contents Label Field setting to Title.
  • Increase PSMF Logbook Record Limit: SafetyDocs supports up to 50 PSMF Logbook Entries per major version of a PSMF document. Contact your Veeva Representative to change this limit.
  • PSMF Logbook Governance: SafetyDocs introduces the ability to enforce strict PSMF document governance by allowing you to configure PSMF Logbook Entries such that:
    • Only the user specified in the Person Making Change field can edit or delete a PSMF Logbook Entry
    • When a PSMF document is part of an active PSMF document workflow and is at version 1.1 or greater, users can only move the document to a steady state if it has a PSMF Logbook Entry from each workflow contributor with an open or complete task associated with the document

      You can make one or both of these configurations, depending on your business requirements. To configure your Vault for this feature, see Configure PSMF Logbook Governance.

23R3 Update: Add Planned Documents to PSMF Binder Templates

With the 23R3 release, PSMF logbooks and eSignature pages are only automatically generated if documents with the PSMF Logbook or PSMF eSignature classifications have been uploaded. This update allows users to customize these documents in their PSMF binders using the Generate PSMF Documents from Vault Reports feature. To configure your Vault for this feature, see Configure Add Planned Documents to PSMF Binder Templates.

23R1 Update: PSMF Table of Contents Template

With the 23R1 release, SafetyDocs can generate a table of contents for PSMF Binders when merging to PDF. The table of contents in the merged PDF includes links to the first page of every document within it. To configure your Vault for this feature, see Configure PSMF Table of Contents Template.

Overview

To configure this feature in your Vault:

Update Object Layouts

To configure object layouts, complete the following for the PSMF Logbook and PSMF Logbook Entry objects:

  1. Copy the standard layout and ensure it is active.
  2. Set the new custom layout as the default.
  3. Delete any other existing custom layouts.

Configure Security

You will need to add security settings to grant access to the new PSMF features. Use the following settings as a starting point, but configure access according to your business process:

Add the PSMF Office Application Role

To add the PSMF Office application role:

  1. Navigate to Admin > Users & Groups > Application Roles.
  2. Select Create.
  3. On the Create Application Role page, enter the following details:
    • Label: Select PSMF Office
    • Name: Enter psmf_office__c
  4. Select Save.

Configure Custom PSMF Permission Sets

To configure custom PSMF permission sets:

  1. Copy the standard PSMF Coordination Actions and PSMF Contributor Actions permission sets. For each permission set, in the Name field, enter [Permission Set]_custom, where [Permission Set] is the name of the permission set.
  2. To manage tab-level permissions for each permission set, grant View permissions for the following tabs:
    • Home
    • Library
    • PSMF
      • PSMF Binders
      • PSMF Logbook
      • Periodic Document Reviews
      • PSMF Generated Documents

Create a PSMF Document Type Group

To create a PSMF Document Type Group:

  1. Navigate to Admin > Configuration > Objects > Document Type Group.
  2. Select Edit.
  3. In the Options section, select the Display in Business Admin checkbox.
  4. Navigate to Business Admin > Objects > Document Type Groups.
  5. Select Create.
  6. On the Create Document Type Group page, in the Name field, enter PSMF Documents, then select Save.

Configure Document Type Permissions

To configure document type permissions:

  1. Navigate to Admin > Configuration > Document Types.
  2. On the Pharmacovigilance System Master File (pharmacovigilance_system_master_file__v) document type, select the Actions menu, then select Edit Details.
  3. In the Edit Details dialog, in the Document Type Groups field, add the PSMF Documents group.
  4. Navigate to the Security tab.
  5. In the Create Document Permission and Create Binder Permission fields, add the All Internal Users group.
  6. Select Save.

Update User Role Setup Object Fields

To update the User Role Setup object fields:

  1. Navigate to Admin > Configuration > Objects > User Role Setup > Fields.
  2. Select Create.
  3. In the Step 1 section, select Object.
  4. In the Step 2 section, in the Label field, enter Document Type Group.
  5. In the Step 3 section, complete the following:
    • In the Object field, select Document Type Group
    • Select the Display in default lists and hovercards checkbox
  6. Select Save.

Configure Object and Document Lifecycles

To configure object and document lifecycles:

Update the PSMF Logbook Entry Lifecycle

To update the PSMF Logbook Entry Lifecycle:

  1. Add the PSMF Office role.
  2. Edit role permissions such that the Edit permission is available only on the Draft lifecycle state.

Configure Document Lifecycles

To configure document lifecycles:

Add the PSMF Office Role

Add the PSMF Office role to the following document lifecycles:

  • PSMF Binder Lifecycle
  • PSMF Content Lifecycle
  • PSMF Generated Document Lifecycle

To add the PSMF Office role:

  1. Navigate to Admin > Configuration > Document Lifecycles > [Lifecycle] > Roles.
  2. Select Create.
  3. In the Label field, enter PSMF Office Role.
  4. In the Application Role field, select PSMF Office.
  5. In the Options section, select the Enable Dynamic Access Control checkbox. In the Confirm Modify dialog, select Continue.
  6. Select Save.
  7. Navigate to the PSMF Office Role then select the Sharing Rules tab.
  8. Select Create, then configure a matching rule as follows:
    • Label: Enter PSMF [Type] - Doctype Group, where [Type] is the document lifecycle type
    • Rule Criteria: Select the Document Type Group (document_type_group__c) checkbox
    • Auto Managed Groups: Enter ${Document Type Group}-${role}
  9. Select Save.

Update Document Lifecycle State Security Settings

To update the PSMF Office role security settings for the applicable document lifecycles:

  1. Navigate to Admin > Configuration > Document Lifecycles > [Lifecycle] > States > [State] > Security Settings.
  2. Select Edit.
  3. For each of the following document lifecycles and states, select the following security settings checkboxes for the PSMF Office role, then select Save:
Document Lifecycle Lifecycle State Security Settings
PSMF Binder Lifecycle Draft
  • View Document
  • View Content
  • Edit Fields
  • Edit Relationships
  • Edit Sharing Settings
  • Annotate
  • Download Source
  • Edit Document
  • Reclassify
In Review
  • View Document
  • View Content
  • Edit Fields
  • Edit Relationships
  • Edit Sharing Settings
In Approval
  • View Document
  • View Content
  • Edit Relationships
  • Edit Sharing Settings
Approved
  • View Document
  • View Content
  • Edit Relationships
  • Edit Sharing Settings
  • Version
  • Download Source
Superseded
  • View Document
  • View Content
PSMF Content Lifecycle Draft
  • View Document
  • View Content
  • Edit Fields
  • Edit Relationships
  • Edit Sharing Settings
  • Annotate
  • Download Source
  • Edit Document
  • Reclassify
In Authoring
  • View Document
  • View Content
  • Edit Fields
  • Edit Relationships
  • Edit Sharing Settings
  • Download Source
  • Edit Document
Ready for Review
  • View Document
  • View Content
In Review
  • View Document
  • View Content
  • Edit Relationships
  • Edit Sharing Settings
  • Annotate
  • Download Source
In Approval
  • View Document
  • View Content
  • Edit Relationships
  • Edit Sharing Settings
Approved
  • View Document
  • View Content
  • Edit Sharing Settings
  • Download Source
Superseded
  • View Document
  • View Content
  • Download Source
Planned
  • View Document
  • View Content
  • Edit Fields
  • Edit Relationships
  • Edit Sharing Settings
  • Download Source
  • Edit Document
PSMF Generated Document Lifecycle Generated
  • View Document
  • View Content
  • Edit Fields
  • Edit Relationships
  • Edit Sharing Settings
  • Annotate
  • Download Source
Final
  • View Document
  • View Content
  • Edit Sharing Settings
  • Download Source
  • Change Owner
Planned
  • View Document
  • View Content
  • Edit Fields
  • Edit Relationships
  • Edit Sharing Settings
  • Download Source
  • Edit Document
  • Delete

Create Document Lifecycle Stage Groups

Create document lifecycle stage groups and stages according to your organization’s process. We recommend the following:

Lifecycle Stage Group Label Document Lifecycle Stage Labels
PSMF Binder PSMF Binder Lifecycle
  • Draft
  • In Progress
  • Approved
PSMF Content PSMF Content Lifecycle
  • Draft
  • Review
  • Approved
PSMF Generated Document PSMF Generated Document Lifecycle
  • Generated
  • Final

Configure Document and Binder Templates

Complete the following configuration if you intend to use controlled document templates in your Vault:

Create Document and Binder Templates

To create PSMF document and binder templates:

  1. Create basic or controlled document templates based on your organization’s requirements.
  2. Create binder templates based on your organization’s requirements, using the Sample PSMF Binder template as a guide, if available in your Vault:
    Sample PSMF Binder Template

Add the Table of Contents Document to PSMF Binder Templates

To add the Table of Contents document to the relevant PSMF Binder templates:

  1. Navigate to Business Admin > Templates > Documents and Binders.
  2. Select the PSMF binder template to which you want to add the table of contents.
  3. Add a planned document to the Introduction section, populating the fields as follows, then select OK:
Field Description
Type Select Pharmacovigilance System Master File.
Subtype Select PSMF Generated Document.
Classification Select PSMF Table of Contents.
Lifecycle Vault populates PSMF Generated Document Lifecycle.
Template Select PSMF Table of Contents Sample.
Planned Name Enter ${name__v} - Table of Contents.

Configure the PSMF Binder Signature Page

To configure the PSMF Binder signature page:

Create a PSMF Binder Signature Template

Create a signature page template and configure it per your organization’s requirements, or complete the fields as follows:

Field Description
Name Enter PSMF Binder Signature Page
Template Selection Select Basic Template
Header (first field) Enter Document Name: ${name__v}
Header (second field) Enter Document ID: ${source_document_id__v}
Signature Block 1 Enter
${signee_name__v}
${signee_title__v}
Signature Block 2 Enter
${signature_verdict__v}
${signature_capacity__v}
${signature_date__v}
Location Select End of Document

Apply the Signature Page Template Overlay to PSMF Content Lifecycle

Apply the PSMF Binder Signature Page universal overlay template to the PSMF Content Lifecycle.

Configure Binder and Document Workflows and Lifecycles

Configure document workflows and lifecycles according to your organization’s process. The following sections provide sample configurations:

Create the PSMF Binder Workflow

To create a document workflow for managing the review and approval process for PSMF Binders:

  1. Navigate to Admin > Configuration > Workflows.
  2. Select Create.
  3. In the Create Workflow dialog, select Document Workflow, then select Continue.
  4. On the Create Workflow page, populate the fields as follows:
    • Label: Enter PSMF Binder Workflow
    • Document Lifecycle: Select PSMF Binder Lifecycle
    • General: Select the Use workflow for single document checkbox
  5. Select Save.
  6. Configure the following workflow steps:
  7. Activate the workflow.

Sample PSMF Binder Workflow

Configure the Start Step

To configure the Start step:

  1. In the Workflow Steps section, select Start.
  2. On the Start step page, select Edit.
  3. In the Details section, populate the Next Steps field as follows:
    • Remove the End step
    • Select Create Step
    • In the Step Name field, enter Action: In Review
    • Select OK
  4. In the Start Options section, select Add Control and populate Control 1 as follows:
    • Control 1: Select Instructions
      • Instructions: Enter You are starting the review for ${docName}. Please specify the reviewer and approver. Note this review is reviewing that all expected documents are present, not their content.
  5. Select Add Control, then populate Control 2 as follows:
    • Control 2: Select Participants
    • Participant Label: Enter PSMF Reviewer
    • Add Participants:
      • Role allowed to participate: Select PSMF Office
      • Select the Allow task instructions for these participants checkbox
      • Select the Default users from sharing settings checkbox
  6. Select Add Control, then populate Control 3 as follows:
    • Control 3: Select Participants
    • Participant Label: Enter PSMF Approver (QPPV)
    • Add Participants:
      • Role allowed to participate: Select PSMF Office
      • Select the Allow task instructions for these participants checkbox
  7. Select Add Control, then populate Control 4 as follows:
    • Control 4: Select Date
    • Label: Enter Due Date
  8. Select Save.
  9. From the Next Steps field, select Action: In Review to navigate to the next step.

Configure the In Review Action Step

To configure the Action: In Review step:

  1. From the Action: In Review step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Action
    • Next Steps
      • Select Create Step
      • In the Step Name field, enter Task: Review
      • Select OK
  3. In the Rules section, select Create Rule then populate the fields as follows:
    • Condition Type: Select Always
    • perform actions: Select Change State
      • Lifecycle State: Select In Review
  4. Select Save.
  5. In the Next Steps field, select Task: Review to navigate to the next step.

Configure the Review Task Step

To configure the Task: Review step:

  1. From the Task: Review step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Task
    • Next Steps
      • Select Create Step
      • In the Step Name field, enter Decision: Move to approval?
      • Select OK
  3. In the General Settings section, populate the fields as follows:
    • Task Label: Enter Review PSMF Binder
    • Assign Task To: Select PSMF Reviewer
      • Select Make available to users in participant group
      • Instructions: Enter Please review the PSMF Binder ${docName} to ensure all expected documents are present.
      • Task Requirement: Select Required
  4. In the Due Date section, populate the Due Date field with Due Date > - > 2.
  5. In the Update Sharing Settings section, select Add rule, then populate the Update Role on Event field with Task Assignment > Add > Reviewer.
  6. In the Prompts section, select the Prompt for Verdicts checkbox, then select Single Verdict: One verdict that applies to all items.
    • In the Verdict Label field that appears, enter Continue to Approval
      • Select Add Comments, then in the Prompt for Comments field, enter Comments
    • Select Add Verdict and in the Verdict Label field that appears, enter Missing content, back to Draft
      • Select Add Comments, then in the Prompt for Comments field, enter Comments
  7. In the Notification section, select Multi-document Workflow Review Task in the Notification Template field.
  8. Select Save.
  9. From the Next Steps field, select Decision: Move to approval? to navigate to the next step.

Configure the Move to Approval Decision Step

To configure the Decision: Move to approval? step:

  1. From the Decision: Move to approval? step page, select Edit.
  2. In the Type field, select Decision.
  3. In the Rules section, select Create Rule and populate the fields as follows:
    • Condition Type: Select All conditions are met
    • if: Select Task > Task: Review > all labels equal > Continue to Approval
    • then: Select Create Step
      • In the Create Step dialog, enter Change State: In Approval
      • Select OK
  4. In the then field of the Else section, select Create Step.
    • In the Create Step dialog, enter Action: Draft (after review)
    • Select OK
  5. Select Save.
  6. In the Rules section, select SC: In Approval to navigate to the next step.

Configure the In Approval State Change Action Step

To configure the SC: In Approval step:

  1. From the SC: In Approval step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Action
    • Next Steps:
      • Select Create Step
      • In the Step Name field, enter Task: Approve
      • Select OK
  3. In the Rules section, select Create Rule and populate the fields as follows:
    • Condition Type: Select Always
    • perform actions: Select Change State
      • Lifecycle State: Select In Approval
  4. Select Save.
  5. From the Next Steps field, select Task: Approve to navigate to the next step.

Configure the Approve Task Step

To configure the Task: Approve step:

  1. From the Task: Approve step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Task
    • Next Steps
      • Select Create Step
      • In the Step Name field, enter Action: Approve
      • Select OK
  3. In the General Settings section, populate the fields as follows:
    • Task Label: Enter Approve PSMF
    • Assign Task To: Select PSMF Approver (QPPV)
      • Select Make available to users in participant group
    • Instructions: Enter Review and approve or reject PSMF Binder ${docName}. Approval will trigger PDF Generation.
    • Task Requirement: Select Required
    • Display information about previous tasks: Select Task: Review
  4. In the Due Date section, populate the Due Date field with Due Date > + > 0.
  5. In the Update Sharing Settings section, select Add rule, then populate the Update Role on Event field with Task Assignment > Add > Approver.
  6. In the Prompts section, select the Prompt for Verdicts checkbox, then select Single Verdict: One verdict that applies to all items.
    • In the Verdict Label field that appears, enter Approved
      • Select Add Capacities
      • In the Capacity Label field, enter Capacity then select the Required checkbox
      • Add the following Capacity Values:
        • QPPV
        • Local QPPV
        • Delegate QPPV
        • QPPV Office
      • Select Add eSignature and populate the Instructions field with You are providing a binding eSignature
    • Select Add Verdict and in the Verdict Label field that appears, enter Rejected, back to Draft
      • Select Add Comments
      • In the Prompt for Comments field, enter Comments, then select the Required checkbox
  7. In the Notification section, populate the following fields:
    • Notification Template: Select Multi-document Workflow Approval Task
    • Select the Include verdicts and comments from previous tasks checkbox
    • Select Tasks: Select Task: Review
  8. Select Save.
  9. From the Next Steps field, select Action: Approve to navigate to the next step.

Configure the Approve Action Step

To configure the Action: Approve step:

  1. From the Action: Approve step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Action
    • Next Steps: Select End
  3. In the Rules section, select Create Rule then populate the fields as follows:
    • Condition Type: Select All conditions are met
    • if: Select Task > Task: Approve > all labels equal > Approved
    • perform actions: Select Change State
      • Lifecycle State: Select Approved
  4. Select Create Rule then populate the fields as follows:
    • Condition Type: Select All conditions are met
    • if: Select Task > Task: Approve > at least one label equals > Rejected, back to Draft
    • perform actions: Select Remove eSignature from items
      • Task: Select Task: Approve
      • Verdicts: Select Approved
    • Select Add Action then populate the fields as follows:
      • Select Change State
      • Lifecycle State: Select Draft
  5. Select Save.
  6. Navigate to the main page of the workflow.

Configure the Draft After Review Action Step

To configure the Action: Draft (after review) step:

  1. From the PSMF Binder Workflow workflow page, select the Action: Draft (after review) step.
  2. From the Action: Draft (after review) step page, select Edit.
  3. In the Details section, populate the fields as follows:
    • Type: Select Action
    • Next Steps: Select End
  4. In the Rules section, select Create Rule and populate the fields as follows:
    • Condition Type: Select Always
    • perform actions: Select Change State
    • Lifecycle State: Select Draft
  5. Select Save.

Activate the Workflow

To activate the PSMF Binder Workflow:

  1. Navigate to the main page of the workflow.
  2. In the Status field within the Details section, select Make configuration active.

Configure the PSMF Binder Lifecycle

To configure the PSMF Binder Lifecycle:

  • Create a user action on the Draft lifecycle state as follows:
    • Condition Type: Select Always
    • Allow the following actions:
      • Select Workflow
      • Select PSMF Binder Workflow
      • Action Label: Enter Start PSMF Review & Approval
  • Create the following entry actions on the Approved lifecycle state:
    • Condition Type: Select Always
    • perform actions: Add the following actions:
      • Set new major version
      • Set previous steady state to superseded
      • Generate PSMF PDF

Create PSMF Content Document Workflows

Create the following document workflows to manage the authoring, review, editing, and approval processes for PSMF documents:

Configure the PSMF Content Authoring Workflow

To configure the PSMF Content Authoring workflow:

  1. Navigate to Admin > Configuration > Workflows.
  2. Select Create.
  3. In the Create Workflow dialog, select Document Workflow, then select Continue.
  4. On the Create Workflow page, populate the fields as follows:
    • Label: Enter PSMF Content Authoring
    • Document Lifecycle: Select PSMF Content Lifecycle
  5. Select Save.
  6. Configure the following workflow steps:
  7. Activate the workflow.

Sample PSMF Content Authoring Workflow

Configure the Start Step

To configure the Start step:

  1. In the Workflow Steps section, select Start.
  2. On the Start step page, select Edit.
  3. In the Details section, populate the Next Steps field as follows:
    • Remove the End step
    • Select Create Step
    • In the Step Name field, enter Action: In Authoring
    • Select OK
  4. In the Start Options section, select Add Control and populate Control 1 as follows:
    • Control 1: Select Instructions
      • Instructions: Enter Please select this document's authors.
  5. Select Add Control, then populate Control 2 as follows:
    • Control 2: Select Participants
    • Participant Label: Enter Authors
    • Add Participants: Select the Allow task instructions for these participants checkbox
  6. Select Add Control, then populate Control 3 as follows:
    • Control 3: Select Date
    • Label: Enter Due Date
  7. Select Save.
  8. From the Next Steps field, select Action: In Authoring to navigate to the next step.
Configure the In Authoring Action Step

To configure the Action: In Authoring step:

  1. From the Action: In Authoring step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Action
    • Next Steps
      • Select Create Step
      • In the Step Name field, enter Task: Author
      • Select OK
  3. In the Rules section, select Create Rule then populate the fields as follows:
    • Condition Type: Select Always
    • perform actions: Select Change State
      • Lifecycle State: Select In Authoring
  4. Select Save.
  5. In the Next Steps field, select Task: Author to navigate to the next step.
Configure the Author Task Step

To configure the Task: Author step:

  1. From the Task: Author step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Task
    • Next Steps
      • Select Create Step
      • In the Step Name field, enter Action: Change State
      • Select OK
  3. In the General Settings section, populate the fields as follows:
    • Task Label: Enter Author Document
    • Assign Task To: Select Authors
      • Select Assign to all users in participant group
      • Instructions: Enter Please author document content and PSMF Logbook comment.
      • Task Requirement: Select Required
  4. In the Due Date section, populate the Due Date field with Due Date > + > 0.
  5. In the Update Sharing Settings section, add the following rules:
    • Task Assignment > Add > Editor
    • Task Completion > Remove > Editor
    • Task Cancellation > Remove > Editor
    • Task Reassignment From > Remove > Editor
  6. In the Prompts section, select the Prompt for Verdicts checkbox, then select Multiple Verdicts: One verdict for each item.
    • In the Verdict Label field that appears, enter Ready for Review
    • Select Add Verdict and in the Verdict Label field that appears, enter Changes Required
      • Select Add Comments, then in the Prompt for Comments field, enter Comments
  7. In the Notification section, select Multi-document Workflow Authoring Task in the Notification Template field.
  8. Select Save.
  9. From the Next Steps field, select Action: Change State to navigate to the next step.
Configure the Change State Action Step

To configure the Action: Change State step:

  1. From the Action: Change State step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Action
    • Next Steps:
      • Select Create Step
      • In the Step Name field, enter Notification: Authored
      • Select OK
  3. In the Rules section, select Create Rule and populate the fields as follows:
    • Condition Type: Select All conditions are met
    • if: Select Task > Task: Author > at least one label equals > Changes Required
    • perform actions: Select Change State
      • Lifecycle State: Select Draft
  4. Select Create Rule and populate the fields as follows:
    • Condition Type: Select All conditions are met
    • if: Select Task > Task: Author > all labels equal > Ready for Review
    • perform actions: Select Change State
      • Lifecycle State: Select Ready for Review
  5. Select Save.
  6. From the Next Steps field, select Notification: Authored to navigate to the next step.
Configure the Authored Notification Step

To configure the Notification: Authored step:

  1. From the Notification: Authored step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Notification
    • Next Steps: Select End
  3. In the Notification Options section, populate the fields as follows:
    • Notification Template: Select Multi-document Workflow Authored
    • Recipient: Select Workflow Owner
      • Select the Include verdicts and comments from previous tasks checkbox
      • Select Tasks: Select Task: Author
  4. Select Save.
Activate the Workflow

To activate the PSMF Content Authoring workflow:

  1. Navigate to the main page of the workflow.
  2. In the Status field within the Details section, select Make configuration active.

Configure the PSMF Content Review Workflow

To configure the PSMF Content Review workflow:

  1. Navigate to Admin > Configuration > Workflows.
  2. Select Create.
  3. In the Create Workflow dialog, select Document Workflow, then select Continue.
  4. On the Create Workflow page, populate the fields as follows:
    • Label: Enter PSMF Content Review
    • Document Lifecycle: Select PSMF Content Lifecycle
  5. Select Save.
  6. Configure the following workflow steps:
  7. Activate the workflow.

Sample PSMF Content Review Workflow

Configure the Start Step

To configure the Start step:

  1. In the Workflow Steps section, select Start.
  2. On the Start step page, select Edit.
  3. In the Details section, populate the Next Steps field as follows:
    • Remove the End step
    • Select Create Step
    • In the Step Name field, enter SC: In Review
    • Select OK
  4. In the Start Options section, select Add Control and populate Control 1 as follows:
    • Control 1: Select Instructions
      • Instructions: Enter You are starting document review. This means no additional edits are required. Please select reviewers and due date.
  5. Select Add Control, then populate Control 2 as follows:
    • Control 2: Select Participants
    • Participant Label: Enter Reviewers
    • Add Participants: Select the Allow task instructions for these participants checkbox
  6. Select Add Control, then populate Control 3 as follows:
    • Control 3: Select Date
    • Label: Enter Due Date
  7. Select Save.
  8. From the Next Steps field, select SC: In Review to navigate to the next step.
Configure the In Review State Change Action Step

To configure the SC: In Review step:

  1. From the SC: In Review step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Action
    • Next Steps:
      • Select Create Step
      • In the Step Name field, enter Task: Review
      • Select OK
  3. In the Rules section, select Create Rule and populate the fields as follows:
    • Condition Type: Select Always
    • perform actions: Select Change State
      • Lifecycle State: Select In Review
  4. Select Save.
  5. From the Next Steps field, select Task: Review to navigate to the next step.
Configure the Review Task Step

To configure the Task: Review step:

  1. From the Task: Review step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Task
    • Next Steps
      • Select Create Step
      • In the Step Name field, enter Decision: Draft
      • Select OK
  3. In the General Settings section, populate the fields as follows:
    • Task Label: Enter Review PSMF Document(s)
    • Assign Task To: Select Reviewers
      • Select Assign to all users in participant group
      • Instructions: Enter Review content and logbook comment for completeness and correctness
      • Task Requirement: Select Required
  4. In the Due Date section, populate the Due Date field with Due Date > - > 3.
  5. In the Update Sharing Settings section, add the following rules:
    • Task Assignment > Add > Reviewer
    • Task Cancellation > Remove > Reviewer
    • Task Reassignment From > Remove > Reviewer
  6. In the Prompts section, select the Prompt for Verdicts checkbox, then select Multiple Verdicts: One verdict for each item.
    • In the Verdict Label field that appears, enter Ready for Approval
    • Select Add Verdict and in the Verdict Label field that appears, enter Rejected
      • Select Add Comments, then in the Prompt for Comments field, enter Reason and select the Required checkbox
  7. In the Notification section, select Multi-document Workflow Review Task in the Notification Template field.
  8. Select Save.
  9. From the Next Steps field, select Decision: Draft to navigate to the next step.
Configure the Draft Decision Step

To configure the Decision: Draft step:

  1. From the Decision: Draft step page, select Edit.
  2. In the Type field, select Decision.
  3. In the Rules section, select Create Rule and populate the fields as follows:
    • Condition Type: Select All conditions are met
    • if: Select Task > Task: Review > at least one label equals > Rejected
    • then: Select Create Step
      • In the Create Step dialog, enter SC: Draft
      • Select OK
  4. In the then field of the Else section, select Create Step.
    • In the Create Step dialog, enter SC: In Approval
    • Select OK
  5. Select Save.
  6. In the Rules section, select SC: Draft to navigate to the next step.
Configure the Draft State Change Action Step

To configure the SC: Draft step:

  1. From the SC: Draft step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Action
    • Next Steps:
      • Select Create Step
      • In the Step Name field, enter Notification: Rejected
      • Select OK
  3. In the Rules section, select Create Rule and populate the fields as follows:
    • Condition Type: Select Always
    • perform actions: Select Change State
      • Lifecycle State: Select Draft
  4. Select Save.
  5. From the Next Steps field, select Notification: Rejected to navigate to the next step.
Configure the Rejected Notification Step

To configure the Notification: Rejected step:

  1. From the Notification: Rejected step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Notification
    • Next Steps: Select End
  3. In the Notification Options section, populate the fields as follows:
    • Notification Template: Select Multi-document Workflow Rejected
    • Recipient: Select Workflow Owner
      • Select the Include verdicts and comments from previous tasks checkbox
      • Select Tasks: Select Task: Review
  4. Select Save.
  5. Navigate to the main page of the workflow.
Configure the In Approval State Change Action Step

To configure the SC: In Approval step:

  1. From the PSMF Content Review workflow page, select the SC: In Approval step.
  2. From the SC: In Approval step page, select Edit.
  3. In the Details section, populate the fields as follows:
    • Type: Select Action
    • Next Steps:
      • Select Create Step
      • In the Step Name field, enter Notification: Reviewed
      • Select OK
  4. In the Rules section, select Create Rule and populate the fields as follows:
    • Condition Type: Select All conditions are met
    • if: Select Task > Task: Review > all labels equal > Ready for Approval
    • then: Select Change State
      • Lifecycle State: Select Ready for Approval
  5. Select Save.
  6. From the Next Steps field, select Notification: Reviewed to navigate to the next step.
Configure the Reviewed Notification Step

To configure the Notification: Reviewed step:

  1. From the Notification: Reviewed step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Notification
    • Next Steps: Select End
  3. In the Notification Options section, populate the fields as follows:
    • Notification Template: Select Multi-document Workflow Reviewed
    • Recipient: Select Workflow Owner
      • Select the Include verdicts and comments from previous tasks checkbox
      • Select Tasks: Select Task: Review
  4. Select Save.
Activate the Workflow

To activate the PSMF Content Review workflow:

  1. Navigate to the main page of the workflow.
  2. In the Status field within the Details section, select Make configuration active.

Configure the PSMF Content Approval Workflow

To configure the PSMF Content Approval workflow:

  1. Navigate to Admin > Configuration > Workflows.
  2. Select Create.
  3. In the Create Workflow dialog, select Document Workflow, then select Continue.
  4. On the Create Workflow page, populate the fields as follows:
    • Label: Enter PSMF Content Approval
    • Document Lifecycle: Select PSMF Content Lifecycle
  5. Select Save.
  6. Configure the following workflow steps:
  7. Activate the workflow.

Sample PSMF Content Approval Workflow

Configure the Start Step

To configure the Start step:

  1. In the Workflow Steps section, select Start.
  2. On the Start step page, select Edit.
  3. In the Details section, populate the Next Steps field as follows:
    • Remove the End step
    • Select Create Step
    • In the Step Name field, enter SC: In Approval
    • Select OK
  4. In the Start Options section, select Add Control and populate Control 1 as follows:
    • Control 1: Select Instructions
      • Instructions: Enter You are starting document approval. This means no additional edits are required.
  5. Select Add Control, then populate Control 2 as follows:
    • Control 2: Select Participants
    • Participant Label: Enter Approver
    • Add Participants: Select the Allow task instructions for these participants checkbox
  6. Select Add Control, then populate Control 3 as follows:
    • Control 3: Select Date
    • Label: Enter Due Date
  7. Select Save.
  8. From the Next Steps field, select SC: In Approval to navigate to the next step.
Configure the In Approval State Change Action Step

To configure the SC: In Approval step:

  1. From the SC: In Approval step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Action
    • Next Steps:
      • Select Create Step
      • In the Step Name field, enter Task: Approve
      • Select OK
  3. In the Rules section, select Create Rule and populate the fields as follows:
    • Condition Type: Select Always
    • perform actions: Select Change State
      • Lifecycle State: Select In Approval
  4. Select Save.
  5. From the Next Steps field, select Task: Approve to navigate to the next step.
Configure the Approve Task Step

To configure the Task: Approve step:

  1. From the Task: Approve step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Task
    • Next Steps
      • Select Create Step
      • In the Step Name field, enter Action: Approved
      • Select OK
    • Tags
      • Select Create Tag
      • In the Label field, enter Approval
      • Select Save
  3. In the General Settings section, populate the fields as follows:
    • Task Label: Enter Approve
    • Assign Task To: Select Approver
      • Select Assign to all users in participant group
      • Instructions: Enter Please review and approve PSMF content documents. This includes reviewing logbook comment
      • Task Requirement: Select Required
  4. In the Due Date section, populate the Due Date field with Due Date > + > 0.
  5. In the Update Sharing Settings section, add the following rules:
    • Task Assignment > Add > Approver
    • Task Cancellation > Remove > Approver
    • Task Reassignment From > Remove > Approver
  6. In the Prompts section, select the Prompt for Verdicts checkbox, then select Multiple Verdicts: One verdict for each item.
    • In the Verdict Label field that appears, enter Approved
      • Select Add Capacities
      • In the Capacity Label field, enter Capacity then select the Required checkbox
      • Add the following Capacity Values:
        • Document Owner
        • Delegate Document Owner
        • QPPV
        • QPPV Office
      • Select Add eSignature and populate the Instructions field with You are providing a compliant eSignature
    • Select Add Verdict
      • In the Verdict Label field that appears, enter Rejected, back to Draft
      • Select the Short-circuit tasks with the configured tags. checkbox
        • Select At least one item has this verdict
        • In the Tags field, select Approval
      • Select Add Comments, then in the Prompt for Comments field, enter Reason and select the Required checkbox
  7. In the Notification section, select Multi-document Workflow Approval Task in the Notification Template field.
  8. Select Save.
  9. From the Next Steps field, select Action: Approved to navigate to the next step.
Configure the Approved Action Step

To configure the Action: Approved step:

  1. From the Action: Approved step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Action
    • Next Steps:
      • Select Create Step
      • In the Step Name field, enter Notification: Approved
      • Select OK
  3. In the Rules section, select Create Rule and populate the fields as follows:
    • Condition Type: Select All conditions are met
    • if: Select Task > Task: Approve > all labels equal > Approved
    • perform actions: Select Change State
      • Lifecycle State: Select Approved
  4. Select Create Rule and populate the fields as follows:
    • Condition Type: Select All conditions are met
    • if: Select Task > Task: Approve > at least one label equals > Rejected, back to Draft
    • perform actions: Select Remove eSignature from items
      • Task: Select Task: Approve
      • Verdicts: Select Approved
    • Select Add Action then populate the fields as follows:
      • Select Change State
      • Lifecycle State: Select Draft
  5. Select Save.
  6. From the Next Steps field, select Notification: Approved to navigate to the next step.
Configure the Approved Notification Step

To configure the Notification: Approved step:

  1. From the Notification: Approved step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Notification
    • Next Steps: Select End
  3. In the Notification Options section, populate the fields as follows:
    • Notification Template: Select Multi-document Workflow Approval
    • Recipient: Select Workflow Owner
      • Select the Include verdicts and comments from previous tasks checkbox
      • Select Tasks: Select Task: Approve
  4. Select Save.
Activate the Workflow

To activate the PSMF Content Approval workflow:

  1. Navigate to the main page of the workflow.
  2. In the Status field within the Details section, select Make configuration active.

Configure the Move to Draft (PSMF Content) Workflow

To configure the Move to Draft (PSMF Content) workflow:

  1. Navigate to Admin > Configuration > Workflows.
  2. Select Create.
  3. In the Create Workflow dialog, select Document Workflow, then select Continue.
  4. On the Create Workflow page, populate the fields as follows:
    • Label: Enter Move to Draft (PSMF Content)
    • Document Lifecycle: Select PSMF Content Lifecycle
  5. Select Save.
  6. Configure the following workflow steps:
  7. Activate the workflow.

Sample Move to Draft (PSMF Content) Workflow

Configure the Start Step

To configure the Start step:

  1. In the Workflow Steps section, select Start.
  2. On the Start step page, select Edit.
  3. In the Details section, populate the Next Steps field as follows:
    • Remove the End step
    • Select Create Step
    • In the Step Name field, enter SC: Draft
    • Select OK
  4. Select Save.
  5. From the Next Steps field, select SC: Draft to navigate to the next step.
Configure the Draft State Change Action Step

To configure the SC: Draft step:

  1. From the SC: Draft step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Action
    • Next Steps: Select End
  3. In the Rules section, select Create Rule and populate the fields as follows:
    • Condition Type: Select Always
    • perform actions: Select Change State
      • Lifecycle State: Select Draft
  4. Select Save.
Activate the Workflow

To activate the Move to Draft (PSMF Content) workflow:

  1. Navigate to the main page of the workflow.
  2. In the Status field within the Details section, select Make configuration active.

Configure the PSMF Content Lifecycle

To allow users to initiate workflows on PSMF Content documents, add user actions on the PSMF Content Lifecycle as follows:

Lifecycle State Action Conditions
Planned
  • Condition Type: Select Always
  • Allow the following actions:
    • Select Workflow
    • Select Move to Draft (PSMF Content)
    • Action Label: Enter Move to Draft
Draft
  • Condition Type: Select Always
  • Allow the following actions:
    • Select Workflow
    • Select PSMF Content Authoring
    • Action Label: Enter Start Authoring

    • Select Workflow
    • Select PSMF Content Review
    • Action Label: Enter Start Review

    • Select Workflow
    • Select PSMF Content Approval
    • Action Label: Enter Start Approval
Ready for Review
  • Condition Type: Select Always
  • Allow the following actions:
    • Select Workflow
    • Select PSMF Content Review
    • Action Label: Enter Start Review

    • Select Workflow
    • Select PSMF Content Approval
    • Action Label: Enter Start Approval
Ready for Approval
  • Condition Type: Select Always
  • Allow the following actions:
    • Select Workflow
    • Select PSMF Content Approval
    • Action Label: Enter Start Approval

Create PSMF Generated Document Workflows

Create the following document workflows to manage the PSMF PDF generation process:

Configure the Move to Generated Workflow

To configure the Move to Generated workflow:

  1. Navigate to Admin > Configuration > Workflows.
  2. Select Create.
  3. In the Create Workflow dialog, select Document Workflow, then select Continue.
  4. On the Create Workflow page, populate the fields as follows:
    • Label: Enter Move to Generated
    • Document Lifecycle: Select PSMF Generated Document Lifecycle
  5. Select Save.
  6. Configure the following workflow steps:
  7. Activate the workflow.

Sample Move to Generated Workflow

Configure the Start Step

To configure the Start step:

  1. In the Workflow Steps section, select Start.
  2. On the Start step page, select Edit.
  3. In the Details section, populate the Next Steps field as follows:
    • Remove the End step
    • Select Create Step
    • In the Step Name field, enter SC: Generated
    • Select OK
  4. Select Save.
  5. From the Next Steps field, select SC: Generated to navigate to the next step.
Configure the Generated State Change Action Step

To configure the SC: Generated step:

  1. From the SC: Generated step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Action
    • Next Steps: Select End
  3. In the Rules section, select Create Rule and populate the fields as follows:
    • Condition Type: Select Always
    • perform actions: Select Change State
      • Lifecycle State: Select Generated
  4. Select Save.
Activate the Workflow

To activate the Move to Generated workflow:

  1. Navigate to the main page of the workflow.
  2. In the Status field within the Details section, select Make configuration active.

Configure the Finalize Generated PSMF Document Workflow

To configure the Finalize Generated PSMF Document workflow:

  1. Navigate to Admin > Configuration > Workflows.
  2. Select Create.
  3. In the Create Workflow dialog, select Document Workflow, then select Continue.
  4. On the Create Workflow page, populate the fields as follows:
    • Label: Enter Finalize Generated PSMF Document
    • Document Lifecycle: Select PSMF Generated Document Lifecycle
  5. Select Save.
  6. Configure the following workflow steps:
  7. Activate the workflow.

Sample Finalize Generated PSMF Document Workflow

Configure the Start Step

To configure the Start step:

  1. In the Workflow Steps section, select Start.
  2. On the Start step page, select Edit.
  3. In the Details section, populate the Next Steps field as follows:
    • Remove the End step
    • Select Create Step
    • In the Step Name field, enter SC: Final
    • Select OK
  4. In the Start Options section, select Add Control and populate Control 1 as follows:
    • Control 1: Select Instructions
      • Instructions: Enter This will finalize the document
  5. Select Save.
  6. From the Next Steps field, select SC: Final to navigate to the next step.
Configure the Final State Change Action Step

To configure the SC: Final step:

  1. From the SC: Final step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Action
    • Next Steps: Select End
  3. In the Rules section, select Create Rule and populate the fields as follows:
    • Condition Type: Select Always
    • perform actions: Select Change State
      • Lifecycle State: Select Final
  4. Select Save.
Activate the Workflow

To activate the Finalize Generated PSMF Document workflow:

  1. Navigate to the main page of the workflow.
  2. In the Status field within the Details section, select Make configuration active.

Configure the Approve PSMF Generated Document Workflow

To configure the Approve PSMF Generated Document workflow:

  1. Navigate to Admin > Configuration > Workflows.
  2. Select Create.
  3. In the Create Workflow dialog, select Document Workflow, then select Continue.
  4. On the Create Workflow page, populate the fields as follows:
    • Label: Enter Approve PSMF Generated Document
    • Document Lifecycle: Select PSMF Generated Document Lifecycle
  5. Select Save.
  6. Configure the following workflow steps:
  7. Activate the workflow.

Sample Approve PSMF Generated Document Workflow

Configure the Start Step

To configure the Start step:

  1. In the Workflow Steps section, select Start.
  2. On the Start step page, select Edit.
  3. In the Details section, populate the Next Steps field as follows:
    • Remove the End step
    • Select Create Step
    • In the Step Name field, enter Update Sharing Settings
    • Select OK
  4. In the Start Options section, select Add Control and populate Control 1 as follows:
    • Control 1: Select Instructions
      • Instructions: Enter This starts a review of generated PSMF documents. Please select the approver and due date
  5. Select Add Control, then populate Control 2 as follows:
    • Control 2: Select Participants
    • Participant Label: Enter Approver
    • Add Participants:
      • Role allowed to participate: Select PSMF Office
      • Select the Allow task instructions for these participants checkbox
      • Select the Default users from sharing settings checkbox
  6. Select Add Control, then populate Control 3 as follows:
    • Control 3: Select Date
    • Label: Enter Due Date
  7. Select Save.
  8. From the Next Steps field, select Update Sharing Settings to navigate to the next step.
Configure the Update Sharing Settings Step

To configure the Update Sharing Settings step:

  1. From the Update Sharing Settings step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Update Sharing Settings
    • Next Steps
      • Select Create Step
      • In the Step Name field, enter Task: Approve
      • Select OK
  3. In the Update Sharing Settings Options section, populate the fields as follows:
    • Workflow Participants: Select Approver
    • Action: Select Add
    • Roles: Select Approver
  4. Select Save.
  5. From the Next Steps field, select Task: Approve to navigate to the next step.
Configure the Approve Task Step

To configure the Task: Approve step:

  1. From the Task: Approve step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Task
    • Next Steps
      • Select Create Step
      • In the Step Name field, enter SC: Approved?
      • Select OK
  3. In the General Settings section, populate the fields as follows:
    • Task Label: Enter Approve Generated Document
    • Assign Task To: Select Approver
      • Select Make available to users in participant group
      • Instructions: Enter Please review and approve or reject ${docName}
      • Task Requirement: Select Required
  4. In the Due Date section, populate the Due Date field with Due Date > + > 0.
  5. In the Prompts section, select the Prompt for Verdicts checkbox, then select Multiple Verdicts: One verdict for each item.
    • In the Verdict Label field that appears, enter Approved
    • Select Add Verdict
      • In the Verdict Label field that appears, enter Rejected
      • Select Add Comments, then in the Prompt for Comments field, enter Reason and select the Required checkbox
  6. In the Notification section, select Multi-document Workflow Approval Task in the Notification Template field.
  7. Select Save.
  8. From the Next Steps field, select SC: Approved? to navigate to the next step.
Configure the Approved State Change Action Step

To configure the SC: Approved? step:

  1. From the SC: Approved? step page, select Edit.
  2. In the Details section, populate the fields as follows:
    • Type: Select Action
    • Next Steps: Select End
  3. In the Rules section, select Create Rule and populate the fields as follows:
    • Condition Type: Select All conditions are met
    • if: Select Task > Task: Approve > all labels equal > Approved
    • perform actions: Select Change State
      • Lifecycle State: Select Final
  4. Select Create Rule then populate the fields as follows:
    • Condition Type: Select All conditions are met
    • if: Select Task > Task: Approve > at least one label equals > Rejected
    • perform actions
      • Select Change State
      • Lifecycle State: Select Rejected
  5. Select Save.
Activate the Workflow

To activate the Approve PSMF Generated Document workflow:

  1. Navigate to the main page of the workflow.
  2. In the Status field within the Details section, select Make configuration active.

Configure the PSMF Generated Document Lifecycle

Add user actions on the PSMF Generated Document Lifecycle as follows:

Lifecycle State Action Conditions
Planned
  • Condition Type: Select Always
  • Allow the following actions:
    • Select Workflow
    • Select Move to Generated
    • Action Label: Enter Move to Generated
Generated
  • Condition Type: Select All conditions are met
  • if: Select Classification > includes > Pharmacovigilance System Master File > PSMF Generated Document > PSMF Generated PDF
  • Allow the following actions:
    • Select Workflow
    • Select Approve PSMF Generated Document
    • Action Label: Enter Start Approval Workflow
  • Condition Type: Select Always
  • Allow the following actions:
    • Select Workflow
    • Select Finalize Generated PSMF Document
    • Action Label: Enter Finalize

Reclassify PSMF Documents Using New Document Types

Reclassify your existing PSMF documents to one of the following dedicated PSMF document types:

  • Pharmacovigilance System Master File > PSMF Binder > PSMF Global Binder
  • Pharmacovigilance System Master File > PSMF Binder > PSMF Local Binder
  • Pharmacovigilance System Master File > PSMF Content > PSMF Title Page
  • Pharmacovigilance System Master File > PSMF Content > PSMF Core Document
  • Pharmacovigilance System Master File > PSMF Content > PSMF Annex
  • Pharmacovigilance System Master File > PSMF Generated Document > PSMF Table of Contents
  • Pharmacovigilance System Master File > PSMF Generated Document > PSMF Logbook
  • Pharmacovigilance System Master File > PSMF Generated Document > PSMF eSignature
  • Pharmacovigilance System Master File > PSMF Generated Document > PSMF Generated PDF
  • Pharmacovigilance System Master File > PSMF Generated Document > PSMF Generated Report

(Optional) Delete Existing PSMF Templates, Document Types, and Document Lifecycles

To transition to the new PSMF functionality, we recommend deleting:

(26R1) Configure PSMF Logbook Governance

To ensure that only the user specified in the Person Making Change field can edit and delete PSMF Logbook Entries:

To enforce the existence of at least one PSMF Logbook Entry before a user can move a PSMF document to a steady state, create an entry action on the Ready for Review state of the PSMF Content Lifecycle document lifecycle with the following settings:

  • Condition Type: Select All conditions are met
  • If:
    • Select Major Version Number > is greater than or equal to > 1
    • Select Add condition
    • Select Minor Version Number > is greater than > 0
  • perform actions: Select Ensure Logbook Entities are Present

(23R3) Configure Add Planned Documents to PSMF Binder Templates

To configure Add Planned Documents to PSMF Binder Templates, you must add planned documents for the PSMF Logbook and PSMF eSignature pages to the PSMF Binder template:

  1. Navigate to Business Admin > Templates > Documents & Binders.
  2. Expand Pharmacovigilance System Master File > PSMF Binder, and then select a binder template to which you want to add the documents.
  3. In the Binder Structure section, select Edit.
  4. Expand the Annexes section and from the All Actions menu for Annex I: Section and Record Control, select Planned Document.
  5. Complete the fields on the Planned Document Details window as follows and then select OK.
    Field Description
    Type Select Pharmacovigilance System Master File.
    Subtype Select PSMF Generated Document.
    Classification Select PSMF Logbook.
    Lifecycle Vault populates the PSMF Generated Document Lifecycle.
    Template Select the template of your choice or select None.
    Planned Name Enter ${name__v} - Logbook.
  6. From the All Actions menu for Annexes, select Planned Document.
  7. Complete the fields on the Planned Document Details window as follows and then select OK.
    Field Description
    Type Select Pharmacovigilance System Master File.
    Subtype Select PSMF Generated Document.
    Classification Select PSMF eSignature Page.
    Lifecycle Vault populates the PSMF Generated Document Lifecycle.
    Template Select the template of your choice or select None.
    Planned Name Enter ${name__v} - eSignature.

(23R1) Configure PSMF Table of Contents Template

To configure the PSMF Table of Contents template:

  1. Download the Safety DOCX table of contents template.
  2. Upload the DOCX table of contents template to your Vault with the following document type classification: Pharmacovigilance System Master File > PSMF Generated Document > PSMF Table of Contents
  3. Add the table of contents document to your PSMF Binder templates.