Note: If a PSMF Request includes a document in its PSMF Document(s) for Submission section, Vault populates the document’s PSMF Request field with that PSMF Request.
), select **Start Authoring**.
3. In the _Start Workflow_ window, enter the following information:
* **Authors**: Select one or more users to author the document.
* Optional: **Instructions**: Enter any instructions for the authors.
* **Due Date**: Use the calendar to select a due date or enter the date manually.
4. Select **Start**.
Vault assigns an _Author Document_ task to the selected authors and updates the document lifecycle state to _In Authoring_. To complete the assigned _Author Document_ task:
1. Navigate to the _Author Document_ task and make the applicable document changes.
2. Select **Complete**.
3. In the _Author Document_ dialog, select the appropriate _Verdict_, then select **Complete**.
Once complete, Vault updates the document lifecycle state to _Ready for Review_.
Note: Depending on your Admin’s configuration, the document may require PSMF Logbook Entries meet the following criteria before you can complete the authoring task:
Note: Link annotations that reference older versions of a PSMF document will result in an error when generating PSMF PDFs. Ensure that link annotations are always referencing the latest version of a PSMF document.
), then select **Start Review**.
2. On the **Start Workflow** window, select options in the following fields:
* **Reviewers**
* **Due Date**
* Optional: Enter any instructions
3. Select **Start**.
Vault updates the document lifecycle state to _In Review_ and assigns a _Review PSMF Document(s)_ task to the selected reviewers.
### Review the PSMF Document {#review}
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, select **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 {#approve}
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, select **Complete**.
2. On the **Approve** page, select from the following options:
* **Approved**
* **Rejected, back to Draft**
3. Complete the fields as follows:
* 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.
4. 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 {#psmf-binders}
_PSMF Binders_ allow you to organize PSMF documents in a flexible binder structure, as well as to [combine the documents into a single PDF][7].
### Create a PSMF Binder {#create-binder}
To create a _PSMF Binder_:
1. Navigate to **PSMF > PSMF Binders**.
2. Create the binder, ideally from a template1, selecting one of the following document types when prompted:
* _Pharmacovigilance System Master File > PSMF Binder > PSMF Global Binder_
* _Pharmacovigilance System Master File > PSMF Binder > PSMF Local Binder_
3. Optional: Add and arrange binder content.
4. Select **Done Editing**.
Note: 1. Depending on your Admin’s configuration, if you create a PSMF Binder from a recommended template, Vault can include a PSMF Table of Contents and a PSMF Logbook-classified document in your PSMF Binder. These placeholder documents allow Vault to generate a table of contents and logbook when merging to a PSMF PDF.
), select **Start PSMF Review & Approval**.
2. In the _Start Workflow_ window, select options in the following fields:
* **PSMF Reviewer**
* **PSMF Approver (QPPV)**
* **Due Date**
3. Optional: Enter instructions for the reviewers and approvers.
4. Select **Start**.
Vault updates the _PSMF Binder_ lifecycle state to _In Review_, and assigns a _Review PSMF Binder_ task to the selected reviewers. Vault selects the latest steady state version of each document within the _PSMF Binder_ for this review.
### Review the PSMF Binder
After reviewing the _PSMF Binder_, indicate your review verdict:
1. From within the _PSMF Binder_ or on the _My Tasks_ page, select **Complete**.
2. In the _Review PSMF_ dialog, select from the following verdicts:
* _Continue to approval_
* _Missing content, back to draft_
3. Select **Complete**.
If the verdict entered was _Continue to approval_, Vault updates the _PSMF Binder_ lifecycle state to _In Approval_, and assigns an _Approve PSMF_ task to the selected approvers. Vault selects the latest steady state version of each document within the _PSMF Binder_ for this approval.
If the verdict entered was _Missing content, back to draft_, Vault updates the _PSMF Binder_ lifecycle state to _Draft_ so the required changes can be made.
### Approve the PSMF Binder
After indicating a review verdict, indicate an approval verdict:
1. From within the _PSMF Binder_ or on the _My Tasks_ page, select **Complete**.
2. In the **Approve PSMF** dialog, select from the following verdicts:
* _Approved_
* _Rejected, back to Draft_
3. Complete the following fields:
* **Capacity**: Select the capacity in which you are rendering a verdict.
* **User Name** and **Password**: Enter your Vault login credentials to enter your eSignature.
4. Select **Complete**.
If the verdict entered was _Approved_, Vault updates the _PSMF Binder_ lifecycle state to _Approved_. Vault generates a PDF of the full _PSMF Binder_ contents, resolving all [link annotations to other locations in the _PSMF Binder_][9] as intra-document links. To access the PDF, select the **Relationships** icon on the Doc Info pane and expand the **Generated PSMF** section.
If the verdict entered was _Rejected, back to draft_, Vault updates the _PSMF Binder_ lifecycle state to _Draft_ so the required changes can be made.
## PSMF Logbook {#psmf-logbook}
To provide a detailed record of changes made to PSMF documents, Vault includes PSMF logbook functionality:
* The [_PSMF Logbook_ document panel][14] displays a list of _PSMF Logbook Entries_, or change records, for a given major version of a document
* If you add a _PSMF Logbook_ placeholder document to a [_PSMF Binder_][5], when [manually][7] or [automatically][10] generating a PSMF PDF for the binder, Vault aggregates all steady-state _PSMF Logbooks_ across all of its _PSMF Content_ documents and:
* Creates a _PSMF Logbook_ Excel report document1 and uploads it to your _Library_, replacing the placeholder _PSMF Logbook_ document in the binder
* Uses this _PSMF Logbook_ document to populate a logbook in the generated PDF
* You can [preview the _PSMF Logbook_][18] for a given _PSMF Binder_ at any time
Note: 1. Depending on your Admin’s configuration, Vault orders PSMF Logbook Entries in the PSMF Logbook document by descending date of entry or by the order of PSMF sections and annexes.
Note: 1. If the document has a Generate Logbook Entry on Draft value of No, Vault does not create a placeholder PSMF Logbook Entry.
) and **Previous** (
) icons to navigate between pages.
To search through the _PSMF Logbook Entries_ on a document, select the search bar then enter a search term and select **Search** (
) icon, or select **Enter** on your keyboard. Vault returns all _PSMF Logbook Entries_ that contain the exact specified term in the _Person Making Change_ or _Summary of Changes_ fields.
#### Add a PSMF Logbook Entry {#add-psmf-logbook-entry}
To manually add a _PSMF Logbook Entry_ to a _PSMF Content_ document:
1. Navigate to the _PSMF Content_ document.
2. From the Doc Info pane, select the **PSMF Logbook** (
) icon to open the _PSMF Logbook_ panel.
3. Select the **Add Logbook Entry** (**+**) icon.
4. Complete the applicable [fields][16], then select **Save**.
Note: You cannot add PSMF Logbook Entries to documents in the Approved state.
##### PSMF Logbook Entry Fields {#logbook-entry-fields}
The following fields may be available:
| Field | Description |
|---|---|
| Date of Change | When Vault creates a PSMF Logbook Entry, this field defaults to the current date. To change it, use the calendar to select the date or enter the date manually. |
| Person Making Change | When Vault creates a PSMF Logbook Entry, this field defaults to the document Owner. When manually creating a PSMF Logbook Entry, Vault populates 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 | When Vault creates a PSMF Logbook Entry, this field is left blank. Enter a description of the changes made to the document. |
) icon.
* To delete a _PSMF Logbook Entry_, select the **Delete** (
) icon. To retain an audit trail, you cannot delete a _PSMF Logbook Entry_ if it is the only _PSMF Logbook Entry_ for the document version.
Depending on your Admin's configuration, you may be able to edit or delete only _PSMF Logbook Entries_ for which you are the user referenced in the _Person Making Change_ field. If you have the _PSMF Office Manager_ role, you may be able to edit any _PSMF Logbook Entries_.
Note: When you delete a PSMF Content document, Vault also deletes the corresponding PSMF Logbook and any associated PSMF Logbook Entries.
Note: To generate a PSMF Table of Contents document, your PSMF Binder must include a document with the Pharmacovigilance System Master File > PSMF Generated Document > PSMF Table of Contents classification created from your Admin’s table of contents template.
Note: Each binder can have only one document of the type Pharmacovigilance System Master File > PSMF Generated Document > PSMF eSignature.