Local Activity Assessment | Veeva Vault Help

Local Activity Assessment provides RIM Registrations users with an easy way to locate and disposition all Activity Change Items for which they are responsible. With a clear view of the remaining work to be completed and a conclusive indication when the changes are complete, users such as labeling specialists and CMC strategists can rely on this feature to easily capture the assessment of the change.

Note: This feature is available in RIM Registrations Vaults only and must be configured by a Vault Admin.

How Local Activity Assessment Works

Local Activity Assessment within the Assess Local Activities viewer streamlines the process of assessing a given Activity and its related Activity Change Items, which are used to track the type of approval, if any, required to make a change in a particular market (its Local Disposition).

For example, a manufacturing change supporting a shelf life extension and accompanying storage condition change may require prior approval in some markets but not others. Additionally, some markets may only require prior approval for the shelf life extension and not the related storage condition change: Local Activity Assessment allows RIM Registrations users to assess every Activity Change Item for its Local Disposition in all markets.

Use Case: Labeling Activity Assessment

At VernBio, there is a single labeling event that spans two products (Cholecap and Wonderdrug), and the event’s related change items have both labeling and artwork impact.

The list below describes when various VernBio employees use the Assess Local Activities viewer to complete their assessments for their given markets (United States, Canada, Costa Rica, Panama).

Linda and Larry are responsible for assessing the Labeling Impact for Activity Change Items related to Cholecap and Wonderdrug, respectively, for the United States.
- Bob, Linda and Larry’s manager, is responsible for setting the Local Disposition after Linda and Larry have completed their assessments.
Agatha is responsible for assessing the Artwork Impact for Activity Change Items related to Cholecap and Wonderdrug for the United States.
Laronda is responsible for assessing Labeling Impact, Artwork Impact, and setting the Local Disposition for Activity Change Items related to Cholecap for Canada.
Arthur is responsible for assessing Labeling Impact, Artwork Impact, and setting the Local Disposition for Activity Change Items related to Wonderdrug for Canada.
Armando is responsible for assessing Labeling Impact, Artwork Impact, and setting the Local Disposition for Activity Change Items for both Cholecap and Wonderdrug for Costa Rica and Panama.

Use Case: Manufacturing Activity Assessment

At VeePharm, a manufacturing event has two change item groupings: one for a new packaging site, and another for a change in packaging material. Both change item groups impact CMC only, however these changes impact ten products for 30 European Union countries and several Asian markets.

The list below describes when various VeePharm employees use the Assess Local Activities viewer to complete their assessments for this wide array of markets.

Carla is responsible for assessing seven of the products for CMC Impact and Local Disposition in all EU markets.
- The packaging regulations are stricter for two of her products: They require prior approval for the packaging material change. For the remaining five products, VeePharm can implement the change to the packaging material, then file a notification with the EMA.
- The new site requires prior approval for all seven products.
Carmelo is responsible for assessing the remaining three products for the EU. He determines that both change items require prior approval for all three products.
Ken is responsible for assessing the packaging material change for all ten products for the Asian markets. He determines that all countries require prior approval except Vietnam, which allows VeePharm to implement and then file.
Charles is responsible for assessing the new site change for Asia. This requires prior approval for all ten products for all markets.

Assessing Local Activities

Vault launches the Assess Local Activities viewer when you run the Assess Local Activities user action from an Event record. To assess local activity records, add at least one filter and click Apply. In the event there are more than 2,000 in-scope records, Vault prompts you to apply additional filters.

In addition to your assigned permissions, your ability to see the action depends upon the record’s lifecycle state. When following the Veeva-recommended configuration, these are:

An Event record in the In Assessment state, or
An Activity record in the Planned, In Assessment, Not Applicable, or Impact Identified states.

When running the action from an Event, this record must have at least one Activity in the appropriate lifecycle state, according to a related setting.

Working with Filters

Once you Apply at least one filter, the viewer displays in-scope records. Each time you adjust a filter row, you must click Apply again to view the resulting records.

The viewer’s top panel includes several filter chips for quickly displaying related data in the grid:

An item which Needs Attention is one that has a missing or invalid value within a currently-visible column. Vault updates this filter as you adjust and re-apply filters in the grid.
The CMC, Labeling, Artwork, Other Impact and Local Disposition filters correspond to that Activity or Activity Change Item record field, for example CMC Impact (cmc_impact__v). Toggling these filters adds or removes the corresponding column within the grid’s common fields.

Below are additional Activity Change Item-specific filter rows, defaulted by Impacted Market. Add up to ten filter rows using the drop-down options. Toggling the filter icon hides or displays any filter rows you’ve applied. During assessment, this can be useful for maximizing the amount of in-view records within the grid while still maintaining your applied filters.

Working with Groupings & Columns

The Assess Local Activities viewer includes a right-hand grouping selector to ensure record fields (columns) are appropriately grouped for your purposes. Grouping options are generally controlled by a related setting, and the Change Item option is used only in Vaults with change item grouping enabled.

Within a grouping, the viewer dynamically displays three collections of columns based on filters and other factors:

Common fields between the Activity and Activity Change Item objects appear to the immediate right of the record hierarchy in the Name column.
- Toggling an impact-specific filter chip (for example, CMC Impact and Artwork Impact as shown here) adds or removes the corresponding column within this area.
- Common fields can include matching custom fields. As shown here, this Vault’s Activity and Activity Change Item objects both include a Common Picklist (common_picklist__c) field. Common matching custom fields persist across all views and cannot be removed.
The center Activity columns are any Activity fields which are not common. Vault only displays these columns within the Impacted Market grouping.
The right-hand Activity Change Item column grouping contains any Activity Change Item fields which are not common.

When you have access to multiple views, you can switch between them while maintaining your selected filters. However, consider the following when working across views:

The viewer maintains column selections from view to view. For example, when you select the Artwork Impact filter chip in the Impacted Market view, this column remains within the common column area when switching to the Change Item view. This behavior similarly applies when you make any other column adjustment, such as adding the Activity Change Item’s Due Date column.
The viewer does not maintain column size across views. When you resize a column in one view, the viewer reverts to the default size upon switching views.

Editing, Saving & Finishing the Assessment

The Assess Local Activities viewer facilitates updating individual field values in the grid using inline editing, or in bulk via fastfill.

To use fastfill to apply the same value to multiple records:

Select records using the checkboxes in the left-hand hierarchy.
Locate the column you’d like to update.
From the column’s fastfill dropdown, select the applicable value(s) to apply to all selected records.

Each time you edit a value and click Save, Vault immediately applies the update. To do this, Vault uses an SDK job to capture each individual Save action, then allows you to save more changes once the job completes.

From here, you can continue editing in the viewer, or click the Finish button to save any remaining changes and exit the viewer. When you Finish, Vault initiates the job again to apply any unsaved changes. Once complete, you’ll receive a Vault email and notification with a results file detailing all updates.

In the event a previously-saved update fails, Vault reverts the update and details it within the results file.

About Simultaneous Assessment

Vault allows multiple users to run the Assess Local Activities action simultaneously. In most cases, records under assessment will only have one responsible person, and users will not experience any unexpected behavior.

However, it is possible that different users may end up simultaneously assessing records. These overlapping records can appear in a user’s filtered results when, for example:

Different users are responsible for assessing different areas for the same Activity Change Items, for example both CMC and labeling.
Different users are responsible for different products that each have different Activity Change Items under the same Activity, in which case that Activity appears in the filtered results for both users.

In the event of simultaneous assessment, Vault applies the updates of the user who first clicks Save, or is the first to save and exit the viewer via the Finish button. Then, any other users who are currently working with the same Event absorb these latest updates when reapplying filters or saving their own updates.

Limitations

It is possible for multiple users to run the Assess Local Activities action simultaneously, which can result in unexpected behavior. See additional details about simultaneous assessment.
The Assess Local Activities viewer displays up to 2,000 rows in the grid, and up to 20 Local Activity columns. Similarly, users can fastfill up to 2,000 rows at a time.

See Configuring Local Activity Assessment for the permissions required to use this feature.