Veeva Quality Docs

BUS-TEC-606 - Multi-Document Workflow and Document

Management Tool
Multi-Document Workflow and Document
Management Tool

Getting Started • There are animations in this pack, so please view in Slide Show mode.
• There is no sound or audio in the pack.
• This training is self-led so you can progress at your own pace.
• This pack will take approximately 15-20 minutes to complete.

Contents 1. Introduction
2. Creating Multi-Document Workflows (MDW)
3. Completing Multi-Document Workflows
4. Document Management Tool (DMT)
Introduction
Learning Objectives
In this module you will learn about:
Multi-Document
Workflows (MDW)
Understand MDWs and how
to use them.
Managing MDW Verdicts
Learn how to progress
MDW workflows with
different verdicts and
complete the workflow.
Preparing Documents Creating MDW
for MDW
Learn how to add multiple Learn how to add the
documents to the Cart and relevant participants and
prepare them for MDW. start an MDW.
Viewing MDWs Using the Document
Management Tool (DMT)
Learn where to find MDW Learn how to use DMT for
Envelopes. Impact Assessment on
document changes.
4
Acronyms Used in this Module

– DtA – Draft to Approved

– DtE – Draft to Effective
– ItF – Initial to Final
– DR - Delayed Release
– QA – Quality Approver
– MDW – Multi-document workflow
– DMT – Document Management Tool

5
Introduction
Multi-Document Workflow (MDW) enables
you to route multiple documents in a
single workflow.
– Multi-Document workflows follow the
same rules as Single-Document
workflows.
– Documents in an MDW must share the
same lifecycle and have the same
value for QA Required?
– All documents in an MDW must have
the same value for Delayed Release
(DR) – only applies for documents with
Draft to Effective (DtE) lifecycle.

6
Introduction continued
You can do reviews,approvals and
retirements in an MDW.
The MDW available depends on the
lifecycle of the documents and the state of
the documents.
Before Steady-State:
There are MDW to review or approve
documents with DtA lifecycle or DtE
lifecycle.
In Steady-State:
There are MDW to Retire documents with
ItF, DtA or DtE lifecycle.

7
Creating
Multi-Document
Workflows (MDW)
Creating MDWs

The easiest way to start an MDW is by

using the Cart functionality. Documents
can be added to your Cart from any view
of the document.
Click on the green +Cart icon to add
documents to your cart.
Click the Cart icon to view documents
placed in your cart.

9
Creating MDWs continued

When you have added all your documents

to the Cart, you can start a Document
Workflow (previously titled Multi-
Document Workflow) from the Actions
Menu.

10
Creating MDWs continued

Select the desired Multi-Document

Workflow from the list.
The following MDW is for a Draft to
Approved (DtA) lifecycle before Steady-
State:
– Approval no QA
– Approval with QA
– Review
The following MDW is for a Draft to
Effective (DtE) lifecycle before Steady-
State :
– Approval no DR no QA
– Approval no DR with QA
– Approval with DR and QA
– Approval with DR no QA 11

– Review
Creating MDWs continued

The following MDW is for a Draft to

Approved (DtA) lifecycle at Steady-State:
– Retirement with QA
– Retirement no QA

The following MDW is for a Draft to

Effective (DtE) lifecycle at Steady-State:
– Retirement with QA
– Retirement no QA

The following MDW is for an Initial to

Final (ItF) lifecycle at Steady-State:
– Retirement Verification
12
Creating MDWs continued

Fill out the Start Document Workflow

information.
When you have completed the fields, click
Start to proceed.

13
MDW Warning Note

QualityDocs will only show you workflows

appropriate with lifecycle, status and
document metadata e.g. Delayed release,
Quality Approval Required?

QualityDocs is unable to prevent you

selecting people who don’t have the
access to complete the task requested.
The system will give you an error
message after selecting the workflow
and clicking Start.

14
MDW Envelopes

An Envelope is a package of documents

sent in an MDW.
Envelope records can be viewed in the
Envelope tab.
Note: You can only view envelope records
for MDW that you either started or are
participating in.
Envelopes have lifecycle states of
Active, Cancelled or Completed.

15
MDW Envelopes continued

You can also view Envelopes from within

a document via the Timeline View.

You can also expand the document

verdicts section to display the verdict for
each document.

16
Completing
Multi-Document
Workflows
Completing MDWs

The status of the Multi-Document

Workflow is displayed at the top of the
page, along with the description (defaults
to type and date).

After the workflow participants have

completed their tasks, you will receive a
notification or a task, depending on their
verdicts.

18
Completing Approval MDWs
continued
You receive a notification if the MDW is
approved by all participants and has
transitioned to Completed.
Table on the right shows the different
notifications and actions that need to
occur for documents with different
Lifecycles in an approval MDW.
Delayed All Verdicts = Yes
Lifecycle Release?
Documents automatically
transition to Approved.
DtA Not
Applicable No action for Workflow
Initiator.
Documents automatically
transition to Effective.
No
No action for Workflow
Initiator.
DtE
Task sent to Release
Coordinator to set Proposed
Effective Date for all
Yes
documents in the Envelope.
No action for Workflow
Initiator.
Mixed Verdicts
Notification sent to Workflow
Initiator for Rejected documents
to take appropriate action and
reroute for approval.
Approved documents
automatically transition to
Approved.
Notification sent to Workflow
Initiator for Rejected documents
to take appropriate action and
reroute for approval.
Approved documents
automatically transition to
Effective.
Remove Rejected Documents
Task is sent to the Workflow
Initiator.
See following slide for next steps.
19
Completing DtE Approval MDWs
continued

If there are differing verdicts in a DtE

Approval workflow with DR is Yes, you will
receive a task ‘Remove Rejected
Documents’.
You have 2 options:
- Continue to Release Coordinator – You
need to remove the rejected documents
by clicking on the X before selecting this
option.
- You can then edit and route the rejected
documents again in another workflow.
- End Workflow – Use this option if you
decide to end the workflow and restart
the process to keep all documents
progressing together.
20
Completing DtE Approval MDWs
continued

If you selected Continue to Release

Coordinator, the Release Coordinator is
tasked with setting the Proposed
Effective Date for all documents in the
workflow.
Note: The same date is applied to all
documents in the envelope.
Once this task is Completed, the
workflow is over.

21
Completing Retirement MDWs
For ItF and DtA, if any Verifier or Approver
(Author, Approver or QA) Fails/Rejects all
documents, the workflow ends and the
workflow initiator is notified.
Once a workflow is complete, any document
that has a verdict of Approve/Pass from all
Approvers/Verifier(s), moves to Retired
immediately.
For any document that has a verdict of
Reject/Fail recorded, when the workflow ends
the reason for retirement is cleared and the
document remains steady-state.

Workflows should not be cancelled or

documents removed from the envelope before
the workflow ends, otherwise the Reason for
Retirement remains visible in the metadata for
the steady-state version. 22
Completing DtE Retirement Workflow Initiator starts

MDWs Retirement MDW

If any approver (Author, Approver or QA) rejects all Author Approves one Author Rejects
documents, the workflow ends and the workflow or more Documents all Documents
initiator is notified.
If there is at least one Approve verdict, the Release
Approver or QA
Coordinator is prompted to enter the proposed Approver Approves one
Approver or QA
Approver Approves
Reason for Retirement &
Proposed Retirement
Retirement Date to complete the workflow. or more Documents Rejects All Date Cleared
Documents* Workflow Ends
The Retirement Approved flag is only set to ‘Yes’
where all approvers have recorded the Verdict of Release Coordinator
confirms proposed * Even if an Approver or
Approve. retirement date QA Approver Rejects All
Documents, the other
For any document that has a verdict of Reject Approvers must
complete their task
recorded, when the workflow ends the reason for
For each document For each document
retirement and proposed retirement field is where everyone where at least one
cleared and the document remains Effective. approves:
Retirement Approved set
approver rejects:
Reason for Retirement &
to Yes Proposed Retirement
Workflows should not be cancelled or Workflow Ends Date Cleared
documents removed from the envelope before the Workflow Ends

workflow ends, otherwise the Reason for Retirement

and Proposed Retirement Date remains visible in Document retires when it
reaches the Proposed
the metadata for the Effective version. Retirement Date 23
Document Management
Tool (DMT)
Introduction

Document Management Tool (DMT) will

Document
allow users to manage In Document
Impact
Open Impact
– Via the Impact assessment Workflow Assessment
Assessment
Completed
Impact Assessments for document
changes in Veeva QualityDocs.
– Via the Action Required task Action
Cancelled
completion associated with Required

document(s)
The 2 workflows can be run independently
and if both workflows are needed run in Action
Closed
any order. Completed

Documents can be linked to the DMT.

DMT has its own Lifecycle, starting as NOTE: Some Business areas will not be using
Open state and Closed when finished. DMT. Follow your local process.

25
Document Management Tool

DMTs should only be used for Draft to

Effective lifecycle documents.
Click on the Document Management
Tool tab to view previously created the
Document Management Tools.
Click Create to start a new DMT record.

26
Document Management Tool
continued

Complete the DMT record details.

Required fields are highlighted in yellow.
Once the record is created, add DtE
documents that have been reviewed and
not yet made Effective.
Do the same for DtE documents to be
Retired.
You can use the same DMT record to
process both.
Note: Documents added to a DMT must
be separately managed in workflows to
progress to these states (Effective and/or
Retired).

27
Document Management Tool
continued

Once the DMT record has been created,

the document(s) that will undergo Impact
Assessment need to be attached.
Click on the Add Button under the
Documents to be made Effective
section to bring up a document selector.
Click the box to select for each document
to add to the DMT.
Click Close once all documents have
been added.
The same actions need to be completed
to add documents being retired.

28
Route for Impact Assessment

Once the DMT record has been set up,

select Route for Impact Assessment
from the Workflow Actions Menu.
Select the Impact Assessment Team and
the Due Date and click Start. The Impact
Assessment Team will assess the impact
of the document(s) change.
The record will move to In Document
Impact Assessment state.

29
Route for Impact Assessment
continued

Impact Assessment Team members will

receive a Task to review the DMT and
enter their comments and verdict.
Upon completion of this task by the
Impact Assessment Team, the DMT will
enter the Document Impact Assessment
Completed state.

Note: when the impact assessment is

completed, you have the availability to re-
route it again for impact assessment,
route for task required or change to
closed.
30
Route for Action Required

From the Open or Document Impact

Assessment Completed state, you can
select Route for Action Required from
the Workflow Actions Menu.
You can select one or more actions and
select one or more people for each.
Names can be the same or different for
each action.
The record will move to Action Required
state and when all Actions have been
marked as Complete, will change to
Action Completed.

31
Close DMT

When no further activity needs to take

place for a DMT, select Change to
Closed from the Workflow Actions
Menu.
The record will move to Closed and will
change to Inactive.

32
Key Takeaways
Critical points to remember about this training

MDW Requirements Viewing MDW DMT

Documents must share the same You can view all MDWs DMT can be used by businesses
lifecycle and certain metadata in (Envelopes) you have initiated or to do Impact Assessments or task
order to be sent in the same MDW. are a participant of. assignments on their document
changes.

1 3 5
–c
2 4 o 6
n
t
i
n
Multi-Document Workflows MDW Types Completing MDW u
Multi-Document Workflows There are different Multi- Select the right option ifean MDW has different
(MDW) enable users to route Document workflows available d
verdicts. Remove and manage rejected
multiple documents on a single depending on the relevant documents separately. 33
workflow. lifecycle and state.