Manage PSMF Binders and Logbooks

Learn how to create and dynamically update binders, generate global and local PSMF PDFs, and view the logbook of changes.

About the Feature

Vault SafetyDocs enables you to easily manage PSMF documents and create global and local PSMF binders. All content is version controlled, and binders can be automatically updated to include the latest documents. All changes are automatically tracked in a PSMF Logbook that includes system- and user-generated logbook entries.

Since content reuse is a key component of the system, you can use the same documents in multiple PSMF binders. Dedicated PSMF templates enable you to set up core content for use in all binders, and customized local content for use in specific regions.

When you need to generate a PSMF PDF, a draft can be quickly reviewed and approved. Next, a single action creates the PDF along with a table of contents and a logbook for the aggregate binder. Finally, the process can also include formal approval and signature steps.

For information on setting up this feature in your Vault, see Enable PSMF Automatic Logbook Generation.

Working with PSMF Documents

To support easy reuse of PSMF documents, Vault SafetyDocs includes 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 > Generated PSMF
• Pharmacovigilance System Master File > PSMF Generated Document > PSMF Generated Report

Upload PSMF documents using the same process as for other document types. For more information, see Adding Documents for more details about adding documents to your Library.

Review and Approve PSMF Documents

The following provides an overview of a review and approval workflow for PSMF Documents and their associated logbooks. Note that your Vault may be configured with alternate steps based on your organization’s processes.

Start the PSMF Document Review

1. For the document that you want to review, go to the Workflow State Change menu () on the Action Bar and select Start Review & Approval.
2. On the Start Workflow window, select options in the following fields:
   • Reviewer
   • Approver
   • Due Date
3. Optionally, enter instructions that will be sent to the reviewers and approvers.
4. Select Start.

Result

The document lifecycle state changes to In Review. A Review PSMF Document(s) task is assigned to the selected reviewers.

Review the PSMF Document

After reviewing the PSMF document, use the following steps to indicate your verdict and move the document to the next stage of the workflow.

1. From within the document or on the My Tasks page, click Complete.
2. On the Review PSMF Document(s) page, select from the following options:
   • No changes needed, ready for approval
   • Changes needed, back to draft
3. Select Complete.

Result

If the verdict entered was “No changes needed, ready for approval”, the document lifecycle state becomes In Approval, and an Approve task is assigned to the selected approvers. If the verdict entered was “Changes needed, back to draft”, the document lifecycle returns to Draft so the required changes can be made.

Approve the PSMF Document

After reviewing the PSMF document, use the following steps to indicate your verdict and move the document to the next stage of the workflow.

1. From within the document or on the My Tasks page, click Complete.
2. On the Approve page, select from the following options:
   • Approved
   • Rejected, back to Draft
   • In the Capacity field, select the capacity in which you are rendering a verdict.
   • In the User Name and Password fields, enter your Vault login credentials to enter your eSignature.
3. Select Complete.

Result

If the verdict entered was “Approved”, the document lifecycle state becomes Approved. In the associated PSMF Logbook, the state becomes Final and the Summary of Changes section can no longer be edited. If the verdict entered was “Rejected, back to draft”, the document lifecycle returns to Draft so the required changes can be made.

Working with PSMF Binders

When you go to PSMF > PSMF Binders, you can create binders using one of the following document types:

• Pharmacovigilance System Master File > PSMF Binder > PSMF Global Binder
• Pharmacovigilance System Master File > PSMF Binder > PSMF Local Binder

For information on adding and arranging binder content, see Merge a Binder to PDF.

Create a Draft of a PSMF Binder

Use the following steps to generate a draft of a PSMF binder. PSMF drafts include all details except for the table of contents.

1. On the All PSMF Binders page, select the binder for which you want to create a draft.
2. In the All Actions menu, select Create Draft.

Result

A draft of the selected PSMF binder is created. The system selects the latest version of each document within the binder to include in this draft.

Review and Approve PSMF Binders

The following provides an overview of an approval workflow for PSMF Binders. Note that your Vault may be configured with alternate steps based on your organization’s processes.

Start the PSMF Binder Review

1. In the Workflow State Change menu () on the Action Bar, select Start PSMF Approval.
2. On the Start Workflow window, select options in the following fields:
   • PSMF Reviewer
   • PSMF Approver (QPPV)
   • Due Date
3. Optionally, enter instructions that will be sent to the reviewers and approvers.
4. Select Start.

Result

The binder lifecycle state changes to In Review, and a Review PSMF Binder task is assigned to the selected reviewers. The system will select the latest steady state version of each document within the binder for this review.

Review the PSMF Binder

After reviewing the PSMF binder, use the following steps to indicate your verdict and move the document to the next stage of the workflow.

1. From within the document or on the My Tasks page, click Complete.
2. On the Review PSMF Binder page, select from the following options:
   • All content present, continue to approval
   • Missing content, back to draft
3. Select Complete.

Result

If the verdict entered was “All content present, continue to approval”, the binder lifecycle state becomes In Approval, and an Approve PSMF task is assigned to the selected approvers. The system will select the latest steady state version of each document within the binder for this approval.

If the verdict entered was “Missing content, back to draft”, the binder lifecycle returns to Draft so the required changes can be made.

Approve the PSMF Binder

After reviewing the PSMF binder, use the following steps to indicate your verdict and move the document to the next stage of the workflow.

1. From within the document or on the My Tasks page, click Complete.
2. On the Approve page, select from the following options:
   • Rejected, back to Draft
3. In the Capacity field, select the capacity in which you are rendering a verdict.
4. In the User Name and Password fields, enter your Vault login credentials to enter your eSignature.
5. Select Complete.

Result

If the verdict entered was "Approved", the binder lifecycle state becomes Approved. The system automatically generates a PDF of the full binder contents. To access the PDF, select the Relationships icon on the Document Panel and expand the Generated PSMF section.

If the verdict entered was “Rejected, back to draft”, the document lifecycle returns to Draft so the required changes can be made.

PSMF Logbook

If a PSMF binder includes a document with the PSMF Logbook classification, the system uses it to generate a logbook leveraging the system-provided PSMF Logbook Template.

Available in all Vaults deployed in 23R1 or later, this enhanced template provides a clear view of all system- and user-initiated changes. It includes details such as:

• Which document was changed
• The date of the change
• The source of the change
• A summary of the change

Every time a change is made to a PSMF document and it is up-versioned, an entry is made in the associated logbook. You can also select the Plus icon to add more entries to the logbook of the document’s current version.

The following fields appear on logbook entries:

Field	Description
Date of Change	Defaults to the current date. To change it, use the calendar to select the date or enter the date manually.
Person Making Change	Defaults to the current user. To change it, select a user from the picklist or select the Advanced Search icon to use filters and refine your search.
Summary of Changes	(Optional) Enter a description of the changes made to the document.

You can edit and delete logbook entries depending on the permissions you have been granted. Contact your Admin for more information about your Vault’s security settings.

When a PSMF PDF is generated from a binder, the steady-state logbooks across all of the associated documents are aggregated into a single file, which is included in the PDF. An example of the final, aggregated logbook is shown below:

Alternatively, if you want your logbook to be customized according to your business requirements, you can set up your Vault to generate the document from a customized report. For more information about this feature, see Generate PSMF Documents from Vault Reports.

Ensure that your Admin has set up a planned document for the logbook in your PSMF Binder template. For more information, see Add Planned Documents to PSMF Binder Templates.

If the text in any field exceeds the maximum Excel row height, the text is split across two rows of the logbook.

Like the uploaded document, the associated PSMF Logbook is in the Draft lifecycle state when first generated.

Preview the PSMF Logbook

You can preview the PSMF Logbook for a binder at any time.

1. On the Analytics tab, select Reports.
2. Select PSMF Binder Logbook.
3. In the Binder > Binder Name field, select the PSMF Binder you want to preview, and then select Continue.

PSMF Table of Contents

When the system is generating a PSMF binder it automatically also creates a table of contents which is merged into the final PSMF PDF.

If using the system-provided template, the system creates a new major version of the table of contents document and sets it to a steady state. With this template, the table of contents in the final PSMF PDF is a clearly formatted table that lists each document within the binder with its respective page number. Each row on the list links to the first page of that document within the binder.

While the system is generating the table of contents, no other actions can be taken on the binder.

Prerequisites

To generate a table of contents, ensure that the following prerequisites have been met:

• To use the system-provided template, your Admin must configure it in your Vault. For more information, see Configure the PSMF Table of Contents Template.
• Your PSMF binder must include a single document that has the following classification: Pharmacovigilance System Master File > PSMF Generated Document > PSMF Table of Contents.

eSignature Page

If the binder includes a document with the PSMF eSignature classification, the system uses it to generate an eSignature page leveraging the eSignature template configured in your Vault. This page is included in the generated PSMF PDF.

Ensure that your Admin has set up a planned document for an eSignature page in your PSMF Binder template. For more information, see Add Planned Documents to PSMF Binder Templates.

Manually Generate a PSMF PDF

To manually generate a PSMF PDF, use the Generate PSMF PDF action. In our recommended configuration, this is done by transitioning the PSMF Binder to the Approved state by completing the following steps:

• Create a draft
• Complete a PSMF Binder Review workflow

Once the PSMF PDF is generated, the document can be downloaded as a source file or a PDF. For more information, see Enabling Cart Download Options.

All pages in the PSMF PDF are numbered in continuous Arabic numerals, including the generated table of contents.