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.

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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 and Logbooks

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

Upload PSMF documents using the same process as for other document types. For more information, see Upload a Document to the Library.

Available PSMF Document Templates

Vault Safety has provided two PSMF templates for use with the PSMF binder. This includes a PSMF Logbook template and a PSMF Table of Contents template.

PSMF Logbook Template

In all Vaults deployed in 23R1 or later, Vault Safety automatically includes an enhanced PSMF Logbook template that provides a clear view of all system- and user-initiated changes. This logs the following details:

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

When PSMF PDFs are generated, the logbook appears as shown below:

Sample PSMF Logbook Based on Template
Sample PSMF Logbook Based on Template

Note If any of your existing PSMF binders include the auto-generated PSMF logbook from Vaults deployed prior to 23R1, you must delete those logbooks to upgrade to the new template. When the associated PSMF PDFs are regenerated, the format is updated. The updated logbook includes all logged changes from before the template change.

PSMF Table of Contents Template

Vault Safety’s PSMF Table of Contents template results in a clearly formatted table with links to each PSMF binder document. For more information about enabling this template in your Vault, see PSMF Table of Contents Template.

When a table of contents is generated with the provided template, it appears as shown below:

Sample PSMF Table of Contents Based on Template
Sample PSMF Table of Contents Based on Template

For more information on this feature, see PSMF Table of Contents.

PSMF Document Logbook and Panel

In addition to all of the standard document functionality, when documents that use the PSMF document type are uploaded, the system automatically generates a PSMF Logbook. The logbook is accessed through the PSMF Document Panel icon (PSMF Document Panel).

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

PSMF Document Panel
PSMF Document Panel
Field Description
Logbook A link to the PSMF Logbook for the document
Logbook Entry A link to the PSMF Logbook Entry for the document
State The lifecycle state of the document
Person Making Change The system automatically populates this field with the name of the person who made the change.
Date of Change The system automatically populates this field with the date of the change.
Summary of Changes Enter a text description of the changes to the PSMF document.

Review and Approve PSMF Documents and Logbooks

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. In the Workflow State Change menu (Workflow-State-Button) on the Action Bar, select Start Review and Approval.
  2. On the Start Workflow window, select options in the following fields:
    • Reviewer
    • Approver
    • Due Date

    Optionally, enter instructions that will be sent to the reviewers and approvers.

  3. 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
  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 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 Adding Binder Content.

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.

eSignature Pages

To generate a PSMF PDF, the PSMF Binder must have at least one eSignature present so that the eSignature page can be generated. The generated eSignature page uses the configured eSignature template on the PSMF Binder Doctype.

Note Each binder can have only one document of the type Pharmacovigilance System Master File > PSMF Generated Document > PSMF eSignature.

If PSMF binders do not include an eSignature document, the system generates one. The name of the system-generated document will be “[Binder Name]-eSignature”.

Vault Safety performs the following steps when including eSignature pages.

  • Creates a new major version of the eSignature document and sets it to a steady state
  • Adds a relationship from the eSignature document to the PSMF Binder
    • To access the PSMF binder from the eSignature document, select the Relationships (Relationships icon) icon on the Document Panel.

Start the PSMF Binder Review

  1. In the Workflow State Change menu (Workflow-State-Button) on the Action Bar, select Start PSMF Binder Review.
  2. On the Start Workflow page, select options in the following fields:
    • PSMF Coordinator
    • QPPV
    • Due Date

    Optionally, enter instructions that will be sent to the reviewers and approvers.

  3. Select Start.

Result

The binder lifecycle state becomes In Review. A Review PSMF Binder task is assigned to the selected reviewers.

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. 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:
    • Approved
    • 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.

Generated PSMF PDF
Generated PSMF PDF

In addition, the logbooks across all of the associated documents are aggregated into a single file, which is included in the binder.

PSMF PDF Automatically Added to PSMF Binder
PSMF PDF Automatically Added to PSMF Binder

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

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 Vault Safety-provided template, the table of contents includes links to binder document headings. Page numbering appears as follows:

  • Roman numerals for documents up to and including the table of contents
  • Number for documents after the table of contents

Prerequisite

To generate a table of contents, PSMF Binders must include a single document that has the following classification: Pharmacovigilance System Master File > PSMF Generated Document > PSMF Table of Contents.

System-Generated Table of Contents

Vault Safety performs the following steps to create the table of contents.

  • Creates links from each table of contents row to document in the binder
  • Creates a new major version of the table of contents document and sets it to a steady state
  • Adds a relationship from the table of contents document to the PSMF Binder
    • To access the PSMF binder from the table of contents document, select the Relationships (Relationships icon) icon on the Document Panel.

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

Preview the PSMF PDF 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.

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

Create a Draft of the PSMF PDF

Use the following steps to generate a draft of the PSMF PDF. Draft PDFs include all details except for the table of contents.

  1. On the All PSMF Binders page, select the binder you want to merge to a PDF.
  2. In the All Actions menu, select Create Draft.
  3. The system automatically creates a new minor version of the binder.
  4. Select Edit, and then Set Binding. Select from the following options:
    Version Binding Option Description
    Always show the Latest Version For all documents, the latest version in any lifecycle state is added to the binder.
    Bind documents to their Latest Steady State Version (if it exists) For all documents, the latest steady state version if added to the binder.
    Bind documents to their Latest Version For all documents, the latest version for each document, regardless of the state, is added to the binder. In this case, the binder will not reflect any future changes to the documents unless a user sets the version binding again. This option does not automatically update existing binders.

Note It is recommended that you select Bind documents to their Latest Steady State Version (if it exists) in step 3.

See Vault Safety Help for more information on Setting Version Binding.

Note When a new version of a PSMF PDF is generated, the version number is updated. However, instead of updating the version number of the associated PSMF logbook, the system generates a new version. This is a known issue that will be fixed in a future release.

Accessing PSMF Logbooks

Access PSMF Logbooks for documents through PSMF > PSMF Logbook. Select into a logbook to view the following details:

  • A link to the logbook entry
  • The document version
  • The date of the change to the document
  • The person who made the change
  • The summary of changes text

Download PSMF PDF

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

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