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Agile Product Lifecycle Management Recipe Management for Pharmaceuticals Administrator Guide
Release 9.3.3
E39287-01
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6 Workflows

This chapter provides details on how to create and manage workflows in Agile Recipe Management for Pharmaceuticals .

6.1 Overview of Recipe Management for Pharmaceuticals Workflows

Workflows are used to automate the approval process.

For example, if you need five people to approve your documents, a workflow can be implemented that automatically forwards all the approval forms to all five people. You have to only submit the document once and it is automatically emailed to all five members in the workflow chain for their approval or rejection.

As another example, you are the Equipment Manager and you may order 150 pieces of equipment in a given year. There are three people in your equipment order process: the original equipment requester, yourself, and your manager, who has to approve or disapprove it. This process can be automated using workflows.

When the request is received, and if any action is taken, an email is sent to all the people involved in the approval chain.


Note:

There is no "crossover" between PLM workflows and Recipe Management for Pharmaceuticals workflows: - Recipe Management for Pharmaceuticals workflows do not carry non-Recipe Management for Pharmaceuticals business objects; - PLM workflows do not carry Recipe Management for Pharmaceuticals business objects.

The Recipe Management for Pharmaceuticals Workflow process uses five components:

  • Authorized Parties

  • Workflow Statuses

  • Workflow Actions

  • Workflow Trigger Actions

  • Business Objects


Caution:

The word "Status" now appears in the top-level UI, e.g., Alerts/Workflows > WF Status. However, many attributes pertaining to workflow "status" still use the word "state". There are also attributes pertaining to aspects of workflows that use the word "status" but do not refer to the main steps of workflows.

6.2 Steps toward Creating Workflows

You can create workflows for other users within your organization. The workflows can then be used by the authorized personnel.

Creating a workflow includes the following steps, which are defined below the list:

  • Selecting a business object

  • Selecting Sites

  • Specifying notification methods

  • Defining trigger actions

  • Define Attribute Conditions to Qualify the Trigger Action

  • Adding Statuses (States)

  • Adding Actions

  • Adding Authorized Parties

  • Specifying Idle and Backup Delays

  • Specifying State Transitions

6.2.1 Selecting a Business Object

Business objects can be used to create approval workflows. There are three business object categories namely, Material, Equipment, and Process. Within each of these categories you have business objects that you can use:

  • Material - Material, Spec Plan, Allocation Request, Dispense Request.

  • Equipment - Equipment, Equipment Qualification, Equipment Reservation, Equipment Activity.

  • Process - Project, Work Request, Campaign, Process Step, Control Recipe.

You cannot create your own Business Objects.

6.2.2 Selecting Sites

A Workflow can be assigned to multiple sites. You can create and modify workflows for only those sites for which you have access permissions.

All the available sites are listed, but the sites that you are authorized to view is enabled.

6.2.3 Specifying Notification Methods

Notifications are sent during any state transition. The means of notifications can be email and dashboards. The primary notification method cannot be selected as secondary again. Notifications are sent to the authorized parties of subsequent state and the additional parties who are selected during workflow definition using both of the (primary and secondary) methods.

You can specify the subject and message of the notifications.

6.2.4 Defining Trigger Actions

Trigger action triggers the workflow. It is a pre-defined action that you can perform on the business object and they are unique to that object. Every object has allowed actions defined. You need to select an action from the allowed actions. For example, New and Remove are some of the trigger actions. You cannot create your own trigger actions.

6.2.5 Defining Attribute Conditions to Qualify the Trigger Action

Workflows are triggered based on various conditions. One of them is the attribute condition. These conditions must be met for an action to trigger the workflow.

6.2.6 Adding Statuses (States) to the Workflow

Each step or stage of a workflow is a workflow status (state). Each state has a status name and state type. Based on the defined state, the authorized parties take actions on the workflow. Before you define a workflow, you must define the states for the object.


Caution:

The word "Status" now appears in the top-level UI, e.g., Alerts/Workflows > WF Status. However, many attributes pertaining to workflow "status" still use the word "state". There are also attributes pertaining to aspects of workflows that use the word "status" but do not refer to the main steps of workflows.

6.2.7 Adding Workflow Actions

Workflow actions are the operations you can perform on any workflow state. For example, Approve, Delete, Edit, Need More Info, Reject, Save, and Submit are some of the predefined workflow actions. For every action on a workflow state, you must specify a destination workflow state.

6.2.8 Adding Authorized Parties

Authorized parties take actions on workflows, for example, by moving the object from one state to another. They can be classified as:

  • Primary Approver party - is the first party to receive the notification about the object state and receives a request for approval action. When the primary approver performs the necessary action, the object in the current state moves to the next state.

However, moving to the next state may depend on consensus from the authorized parties also, where all the authorized parties should take actions. Primary approver can be a Role, User, User Groups, or Macro.

  • Backup Approver party - is the second party to receive the notification, when the Primary party does not respond. You must specify the delay, after which the task moves from the Primary approver party to the Backup approver party.

The backup delay period is the waiting period for the primary approver to act on any action.

If backup approver is not specified, the application sends the alert to the requester.

6.2.9 Specifying Idle and Backup Delays

You must specify the delay for taking actions and move the current workflow state to the next. Delays are classified as:

  • Idle delay - determines when the initiator of the task has to be notified that no one (including the Backup Party, if any) has taken action.

  • Backup delay - defines the delay, after which the task moves from the Primary Party to the Backup Party.

If neither the primary approver(s) nor the backup approver(s) have taken any action (even after the backup delays), the workflow sends a "No Action Alert" to the workflow requester. Also, these workflow tasks remain as pending tasks on the primary and backup party's task list. Now, the initiator can notify you about the pending workflow.

6.2.10 Specifying State Transitions

You must define state transitions to automate the Workflow. If a workflow is in state s1, upon action a1, it advances to state s2.

For each Starting or Intermediate state, you can specify if you require a consensus on one of its actions from all authorized parties. You can specify if all authorized parties are required to take some action before a state transition happens or any one authorized party taking action can result in a state transition.

For example, there is a workflow with states Review, Rejected, Approved, and Draft. Suppose the Review state had the following actions defined: Reject, Accept, and Need More Info. The transitions for these actions are:

  • Reject Action to Rejected state

  • Approve Action to Approved state

  • Need More Info Action to Draft state

While defining the workflow state, if you select ALL for the Approve action, then the workflow enforces ANY for all the other remaining actions in this workflow state (namely, Reject and Need More Info).

During execution, if all authorized parties select the Approve action for the Review state, the workflow state is moved to the Approved state. If one of the authorized parties take an action other than Approve, the state moves to either Rejected or Draft (based on the transition matrix defined.)

During state transition, the configured notification(s) are sent to the authorized parties of next state.

6.2.11 Workflow Tasks

The authorized approver parties of the workflow are prompted to perform actions to push the workflow states to the next state. These actions are allowed on the current state of the object in the workflow. If you cannot perform a workflow action or task, you can delegate it to another user. This can be done through the Task pane on your Home page. For more information, see Task Management.

6.3 Creating a Workflow

To create a workflow:

  1. In the Tools & Settings menu, select Alerts/Workflows > Workflows > New.

  2. In the Object tab, select the object or the category to which you want to associate the workflow.

  3. Click Next.

  4. The General tab has three subtabs:

    • Identity

    • Sites

    • Notifications

    In the Identity subtab, specify the following information about the workflow:

    • Name - Enter the name of the workflow.

    • Operating Mode - Select the operating mode.

    • Effective Start Date - Enter the effective start date.

    • Effective End Date - Enter the effective end date.

    • Description - Write a brief description about the workflow.

  5. Click Next

  6. In the Sites subtab, click Add and select the sites to associate the workflow and click OK. The selected site(s) appear in the Sites subtab.

    If you want to add more sites, click Add and repeat this procedure.

  7. Click Next.

  8. In the Notifications subtab, specify the following information on how the authorized party must be notified:

    • Primary Notification Method - select Dashboard or Email.

    • Optional Notification method - the method you selected for Primary is now disabled; select the other method.

    • Subject - enter the subject for the notification message.

    • Message - enter the message details.

  9. Click Next.

  10. The Trigger tab has three subtabs:

    • Actions

    • Attributes

    • Conditions

    In the Actions subtab, select the actions for which the workflow must be triggered and click Next.

  11. In the Attributes subtab, if the attribute conditions will be used to qualify the trigger action, select the attributes to be included in the condition and then click Next.

  12. In the Conditions subtab, specify for each attribute the condition that must be met for the workflow to be triggered.

  13. Click Next.

  14. In the States tab, do the following to add states to the workflow:

    • Click Add a State.

    • In the Choose State subtab, select the state and specify if it is the Starting, Intermediate, or Ending state for this workflow.


      Note:

      Ensure you add at least two states when defining a workflow; the Starting state and the Ending state.

    • Click Next.

    • You need to define the states for the object before you define a workflow. For information about defining states, see Workflow State.

    • In the Details ubtab, specify the following:

    • In the Details subtab, specify the following:

      • In the Actions subtab, select the actions to be allowed for the specifed states and click Next.

      • In the Authorized Parties subtab, click New to specify the parties who can take actions on the workflow.

  15. In the Primary Party subtab, you can specify the roles, macros, groups and users. Click Next.

  16. In the Backup Party subtab, specify another role, user, macro, or group as the backup party. Click Next. The selected primary and the backup parties appear in the Authorized parties subtab.

  17. Click Next.

  18. In the Delays subtab, specify the Backup Delay after which the action can be taken by the backup party. The Idle Delay determines when the initiator of the task is notified that no one has taken action on the workflow.

  19. Click Next. The selected state appears in the States tab.

  20. Click Next.

  21. The Transitions tab has three subtabs:

    • Next State

    • Consensus

    • Parties to Notify

    In the Next State subtab, select the next state for each action on a state, specify the version change and if any signature is required.


    Note:

    You can use the System Actions option to stop the workflow.

  22. Click Next.

  23. In the Consensus subtab, for each action in the state, select the Destination state and click Next.

  24. In the Parties to Notify subtab, select one or more state transitions and click Set Parties to Notify to specify the people to be notified.

  25. In Parties to Notify, select the roles, macros, groups, or users to be notified when the selected actions are taken.

  26. Click Add to Notify List. The selected parties appear in Parties to Notify.

  27. Click Preview Notification to view the Notification details.

  28. Click OK and then click Finish. You have created a workflow, and the confirmation message appears.

6.4 Managing Workflows

You can edit, duplicate, activate/deactivate, remove and set status for workflow. You can perform these tasks when searching or browsing for the workflow.

6.4.1 Searching Workflow

To search for a workflow:

  1. In the Tools & Settings menu, select Alerts/Workflows > Workflows > Manage.

  2. Select a search view from the View dropdown list. By default, the Basic view is selected.

  3. In the Workflows definition area, use the dropdown menus to fill in criteria of the workflows you are interested in finding.

    You can also search without filling in any criteria.

  4. When you have filled in sufficient criteria, click Search.

6.4.2 Browse Workflow

To browse for a workflow:

  1. In the Tools & Settings menu, select Alerts/Workflows > Workflows > Manage.

  2. Click the Browse tab.

  3. Select an object for which you want to view the associated workflows. Workflows displays the list of workflows for the selected object.

6.4.3 Viewing Workflow

You can view the workflow details in Details.

To view the details for a workflow:

  1. In the Tools & Settings menu, select Alerts/Workflows > Workflows > Manage.

  2. Perform a search or browse for the workflow.

  3. In Workflow ID, click on the workflow ID to view the details.

6.4.4 Editing Workflow

Workflow can be edited in Draft and Review states.

To edit workflow details:

  1. In the Tools & Settings menu, select Alerts/Workflows > Workflows > Manage.

  2. Perform a search or browse for the workflow.

  3. In Workflows, select the workflow for which you want to edit the details and Edit.

  4. Enter information in the various fields.

  5. Click OK.

6.4.5 Removing Workflow

You cannot remove a workflow that is in use.

To remove a workflow:

  1. In the Tools & Settings menu, select Alerts/Workflows > Workflows > Manage.

  2. Perform a search or browse for the workflow.

  3. In Workflows, select the workflow that you want to remove and click Delete.

    The confirmation message appears.

6.4.6 Duplicating Workflow

You can create a new instance of an existing workflow with a new name, but with the same details. You can duplicate a canceled workflow as well.

To duplicate a workflow:

  1. In the Tools & Settings menu, select Alerts/Workflows > Workflows > Manage.

  2. Perform a search or browse for the workflow. Workflows displays a list of workflows.

  3. In Workflows, select the workflow that you want to duplicate.

  4. Click More and select Save As.

  5. In Duplicate Workflow, enter information in the various fields.

  6. Click OK.

6.4.7 Activating and Deactivating a Workflow

You can activate or deactivate a released workflow. Deactivated workflows cannot be started. A deactivated workflow can be activated, if not in Canceled state.

To activate or deactivate a workflow:

  1. In the Tools & Settings menu, select Alerts/Workflows > Workflows > Manage.

  2. Browse or search for the workflow.

  3. In Workflows, select the workflow that you want to activate or deactivate.

  4. Click More and select Activate, to activate the workflow. Click OK. You have activated the workflow.

    To deactivate the workflow, click More and select Deactivate. Click OK. You have deactivated the workflow.

6.5 Workflow Status

Workflow statuses are the steps or stages of a workflow. A workflow status has a State Name and State Version. You can define any number of statuses in an Recipe Management for Pharmaceuticals workflow.

Examples of status (state) names include Draft, Release for Review, Approved, Rejected, and On Hold. Workflow statuses with the same name can exist in two different workflows; however, two statuses with the same name cannot exist within a single workflow.

You can create your own workflow statuses.

You can create, search, view, edit, duplicate, and remove workflow statuses.


Caution:

The word "Status" now appears in the top-level UI, e.g., Alerts/Workflows > WF Status. However, many attributes pertaining to workflow "status" still use the word "state". There are also attributes pertaining to aspects of workflows that use the word "status" but do not refer to the main steps of workflows.

6.5.1 State Type of Workflow Status

State Types are Start, Intermediate, or Final.

Each workflow must have:

  • A workflow state of State Type Start

  • A workflow state of State Type Final

You can specify a workflow to stop in any of its states.

6.5.2 Setting Workflow Status

Workflows can have the following states:

  • Draft - this is the initial state of the workflow. In this status, the workflow can be modified as many times without affecting the version number of the workflow.

  • Review - when a user submits a workflow for review, the workflow moves from the Draft to the Review state.

  • Released - when a user approves a workflow, it moves from the Draft to the Released state.

  • Canceled - when a user cancels a workflow that is in the Draft, Review, or Released state, it moves to the Canceled state.

Once a workflow is in Canceled state, it cannot move to any other state. It can be removed if it has not been used, even once.

To change the state of the workflow:

  1. In the Tools & Settings menu, select Alerts/Workflows > Workflows > Manage.

  2. Perform a search for the workflow.

  3. Select the workflow for which you want to change the state and click Change> Lifecycle Phase and select the required state.

  4. Click OK.

6.5.3 Creating a Workflow Status

To add new state:

  1. In the Tools & Settings menu, select Alerts/Workflows > WF Status > New.

  2. In the General tab, select the object for which you want to create a workflow state.

  3. Click Next.

  4. In the Details tab, enter information for the following fields:

    • State Name - Enter the name of the state.

    • State Description - Write a brief description about the state.

    • Lifecycle Phase - Select the lifecycle phase.

    • Allow stop workflow - Select the option, if you want to stop workflow.

  5. Click Finish. The confirmation message appears.

6.5.4 Searching Workflow Status

To search for a state:

  1. In the Tools & Settings menu, select Alerts/Workflows > WF Status > Manage.

  2. In the Object States definition area, use the dropdown menus to fill in criteria of the workflows you are interested in finding.

  3. When you have filled in sufficient criteria, click Search.

6.5.5 Browsing Workflow Status

To browse for a state:

  1. In the Tools & Settings menu, select Alerts/Workflows > WF Status > Manage.

  2. Click the Browse tab.

  3. Select the object for which you want to view the states. You can view a list of states for the selected object in States.

6.5.6 Viewing Workflow Status

To view details for a state:

  1. In the Tools & Settings menu, select Alerts/Workflows > WF Status > Manage.

  2. Click the Browse tab.

  3. Select the object for which you want to view the states.

  4. In State Name, click on the state name to view the details.

6.5.7 Editing Workflow Status

To edit details for a state:

  1. In the Tools & Settings menu, select Alerts/Workflows > WF Status > Manage.

  2. Perform a search or browse for the state.

  3. Select the state that you want to edit and click Edit States.

  4. In Edit Object State, enter information for the following fields:

    • State Name

    • Description

    • Lifecycle Phase

    • Allow stop workflow

  5. Click OK.

You have edited the state and a confirmation message appears.

6.5.8 Releasing Object State

A business object must have at least two released states so that a workflow can be created for it.

To release an object state:

  1. In the Tools & Settings menu, select Alerts/Workflows > WF Status > Manage.

  2. Perform a search or browse for the object.

  3. Edit the object state(s) you want to release and click Release.

    You have released the selected state for the object, and a confirmation message appears.

6.5.9 Removing Object State

To remove an object state:

  1. In the Tools & Settings menu, select Alerts/Workflows > WF Status > Manage.

    • From the Search tab, search for a state, select the Business Object that contains the state you want to delete, and click Edit States.

    • From the Browse tab, select an object that has the state that you want to delete.

  2. Perform a search or browse for the object with the related state.

  3. Select the state that you want to remove and click Delete.

    The state is removed for the object.

6.6 Workflow Action

Workflow actions are operations you can perform on any workflow status. Examples of workflow actions include Approve, Delete, Edit, Need More Info, Reject, Save, and Submit. You can create, search, view, modify, duplicate, and remove workflow actions.

6.6.1 Creating a Workflow Action

To add a new workflow state action:

  1. In the Tools & Settings menu, select Alerts/Workflows > WF Action > New.

  2. Enter information for the following fields:

    • Action Name

    • Action Description

    • Active

  3. Click Finish. You have added a new workflow action and a confirmation message appears.

6.6.2 Searching Workflow Action

To search for a workflow state action:

  1. In the Tools & Settings menu, select Alerts/Workflows > WF Action > Manage.

  2. Select a search view from the View dropdown list.

6.6.3 Viewing Workflow Action

To view workflow action details:

  1. In the Tools & Settings menu, select Alerts/Workflows > WF Action > Manage.

  2. Perform a search for the workflow action.

  3. In Action Name, click on the workflow action name for which you want to view the details.

6.6.4 Editing Workflow Action

To edit details for a workflow action:

  1. In the Tools & Settings menu, select Alerts/Workflows > WF Action > Manage.

  2. Perform a search for the workflow action.

  3. Select the workflow action for which you want to edit the details and click Edit.

  4. Enter the information in the following fields:

    • Action Name

    • Action Description

    • Active

  5. Click OK.

6.6.5 Duplicating Workflow Action

You can create a new instance of an existing workflow action with a different name.

To duplicate a workflow action:

  1. In the Tools & Settings menu, select Alerts/Workflows > WF Action > Manage.

  2. Perform a search for the workflow action.

  3. Select the workflow action for which you want to duplicate and click More > Save As.

  4. In Duplicate Action, enter the Action Name.

  5. Select Notes and Attachments, if you want to add notes and attachments to the action name.

  6. Click Save and Edit to change the associated details or click OK to save the duplicated workflow action without changing the associated details. To cancel, click Cancel.

6.6.6 Removing Workflow Action

To remove a workflow action:

  1. In the Tools & Settings menu, select Alerts/Workflows > WF Action > Manage.

  2. Perform a search for the workflow action.

  3. Select the workflow action for that you want to remove and click Delete.

    You have removed the workflow action and a confirmation message appears.

6.7 Workflow Statuses Versioning

A set of workflow states for a given object is versioned. If you add, modify, or delete the existing set of workflow states for an object, the version number for the set of states is incremented. However, the new or modified workflow states have to be released for the version to be incremented.

Versioning of workflow states is helpful as the administrator can attach the workflow to any current or previous versions of the object state set(s) with Released state.