New and Improved Features

Product Level change

• PMP-48114 Add option to Track action items for each assigned owner individually  

Configurable

• PMP-47100 As an end user would like to have 12 week CAPA verification process in Action Item
• PMP-56618 Action Item Expansion Functionality & EEM / EPM

PMP-48114 Add option to Track action items for each assigned owner individually

Configurable: No (Enable and Disable using Common Action Item Framework Configuration)

• Title: NA
• Public / Private: NA
• Default: NA

Existing System: 

No option to create Action Item individually for each assigned owners.

Purpose:

Option to create Action Item individually for each assigned owners. This will help to create same Action Item for multiple owners at a time, rather creating multiple time for each owner.

Enhanced System:

• Provided an option to create Action Item individually for each assigned owners. 
• The option will be default to uncheck. If user selects the option, after saving the option will be again unchecked.
• Action Item Create/Update and other mail will be sent individually to each owners.

Impacts: None

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PMP-47100 As an end user would like to have 12 week CAPA verification process in Action Item

Configurable: No (Enable and Disable using Common Action Item Framework Configuration)

• Title: NA
• Public / Private: NA
• Default: NA

Existing System: 

Doesn't have an option for 12 Week Action Item Verification

Purpose:

Limit the Closing of Completed Long Term Countermeasures until a period of 12 weeks from the date of the Completion has occurred.

Enhanced System:

• Verify Users should have the ability to Reject but not the ability to Close a Completed Long Term Countermeasure during the 12 week (84 days) time period following the Action Item Completed Date.
• Until the 12 week time period is met, Verify Users will only have the available values Open (default value) and Reject in the Verification Status field.
• Upon reaching the end of the 12 week time period from the Action Item Completed Date, the Verification Status field will have three available options for selection: Open (default value), Closed, and Reject.
• When a Long Term Countermeasure is rejected, the Action Item Status should not update to Open as found in the existing system.
  1. When a Long Term Countermeasure’s Verification Status is updated to Reject, the Action Item Status shall be automatically updated to Closed.
• For Long Term Countermeasures with Verification Required, the following notifications are required:
  1. An initial notification will be sent to Verify Users 84 days after the Action Item Completed Date for Long Term Countermeasures where the Verification Status is Open.
  2. Recurring notifications will then be sent to the Verify Users every 7 days after the initial notification until the Verification Status is updated to either Closed or Reject.
  3. The notifications will request the Verification to be completed and include a hyperlink to the Long Term Countermeasure.

Impacts: None

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PMP-56618 Action Item Expansion Functionality & EEM / EPM

Configurable: No

• Title: NA
• Public / Private: NA
• Default: NA

Existing System: 

Purpose:

Enhanced System:

• For a Long Term Countermeasure
  1. Provide field "Applicable to expansion?" 
  2. If  "Applicable to expansion?" is 'Yes'  then ask to provide “Description of Actions to be Expanded”
  3. Provide field "Applicable to EEM/EPM info?"
  4. If Applicable to EEM/EPM info?  is ‘Yes’ then ask to provide “EEM or EPM"
  5. If Applicable to EEM/EPM info? is ‘Yes’ then ask to provide “EEM/EPM info Submitted”
  6. If "EEM/EPM info Submitted" is ‘Yes’ then ask to provide  “Document Number” 

Impacts: Mobile, Feed, Cognos (v19.1)

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