Application Default Notifications

SmartComm™ is the SmartSolve communication tool used to communicate information to users and systems based on events. Notifications are delivered through an SMTP server. SmartComm plays a key role in processing notifications and application workflow events.

SmartComm is based on push technology. Push technology allows companies to set up user-defined rules based on conditions that require attention. Based on the rules, when certain conditions are met the system sends an email to a defined list of recipients. The email message contains a click-able link to the login page and to the item which needs attention.

SmartComm supports the following CAPA Management function:

CAPA Default Emails

Event Email

CAPA Creation

Condition: New CAPA is created.

Notify To: CAPA Coordinator

Subject: CAPA: $CAPA No. $ is recorded.

Message: CAPA: $CAPA No. $ is recorded and assigned to you.

Interval: Once

Investigation Task Routed

Condition: When Investigation task is routed.

Notify To: Investigation Task Owner

Subject: Investigation for CAPA: $ CAPA No. $ has been assigned to you.

Message: Investigation for CAPA: $ CAPA No. $ has been assigned to you. Due Date of this investigation is $

Investigation Due Date $

Interval:

  • When Task is routed
  • 1 day before Due Date
  • 1 day after due date to the Task owner's manager

Investigation Approval Routed

Condition:When Investigation Approval task is routed.

Notify To: Investigation Approval Task Owner

Subject:Investigation approval for CAPA: $ CAPA No. $ has been assigned to you.

Message: Investigation approval for CAPA: $ CAPA No. $ has been assigned to you.

Interval:Once

Investigation Approved

Condition: When Investigation is approved.

Notify To: CAPA Coordinator and Investigation Task Owner

Subject: Investigation of CAPA: $ CAPA No. $ has been Approved.

Message: Investigation of CAPA: $ CAPA No. $ has been Approved.

Interval: Once

Investigation Rejected

Condition: When Investigation is Rejected.

Notify To: Investigation Task Owner

CC: CAPA Coordinator

Subject: Investigation of CAPA: $ CAPA No. $ has been Rejected.

Message: Investigation of CAPA: $ CAPA No. $ has been Rejected with the Comment: $ Rejected Comment $.

Interval: Once

Due Date Extension Routed

Approver is Coordinator

Condition: When Due Date Extension is requested.

Notify To: Due Date Extension Approver

Subject: Due Date Extension - $PHASE$ requested for CAPA: $RECORD_NUMBER$.

Message: Due Date Extension - $PHASE$ requested for CAPA: $RECORD_NUMBER$. Requested New Date: $V_SS_CAPA-V_SS_CAPA_EXTENSION/REVISED_DUEDATE$.

Interval: Escalation Based

Due Date Extension Routed

Approver is not Coordinator

Condition: When Due Date Extension is requested and Approver is not the same as the Coordinator.

Notify To:CAPA Coordinator

Subject: Due Date Extension - $PHASE$ requested for CAPA: $RECORD_NUMBER$.

Message: Due Date Extension - $PHASE$ requested for CAPA: $RECORD_NUMBER$. Requested New Date: $V_SS_CAPA-V_SS_CAPA_EXTENSION/REVISED_DUEDATE$.

Interval: Once

Task Due Date is Changed

Condition: Task due date is changed.

Notify To: Task owner

Subject: Due Date Change - $Task Name$ for CAPA: $ CAPA No. $.

Message: The due date of $Task Name$ for CAPA: $ CAPA No. $. was changed. The new due date is $ New Due Date $.

Interval: Once

NOTE: The parameter value for $Task Name$ should be like investigation or implementation or implementation verification or etc. depending upon which task’s due date was changed

Due Date Extension Rejected

Condition: When Due Date Extension is rejected.

Notify To: Task Owner

Subject: Due Date Change - $PHASE$ for CAPA: $RECORD_NUMBER$ has been rejected.

Message: Due Date Change - $PHASE$ for CAPA: $RECORD_NUMBER$ has been rejected. Rejection Comment.

Interval: Once

Implementation Task Routed

Condition: When Implementation task is routed.

Notify To: Implementation Task Owner

Subject: Implementation for CAPA: $ CAPA No. $ has been assigned to you.

Message: Implementation for CAPA: $ CAPA No. $ has been assigned to you. The action plans have been routed to the action plan assignees. Due Date of this Implementation is $ Implementation Due Date $.

Interval:

  • When Task is routed.
  • 1 day before Due Date.
  • 1 day after due date to the Task owner's manager.

Action Plan Task Routed

Condition: When Action Plan task is routed.

Notify To: Action plan Task Owner

Subject: Action plan for CAPA: $ CAPA No. $ has been assigned to you.

Message: Action plan for CAPA: $ CAPA No. $ has been assigned to you. Due Date of this action plan is $ Action plan Due Date $.

Interval:

  • When Task is routed.
  • 1 day before Due Date.
  • 1 day after due date to the Task owner's manager.

Implementation Verification

Condition: When Implementation Verification task is routed.

Notify To: Implementation verification Task Owner

Subject: Implementation verification for CAPA: $ CAPA No. $ has been assigned to you.

Message: Implementation verification for CAPA: $ CAPA No. $ has been assigned to you.

Interval: Once

Implementation Verification

Acceptable

Condition: When Implementation Verification is approved.

Notify To: CAPA Coordinator and Investigation Task Owner and Implementation Task Owner

Subject: Implementation verification of CAPA: $ CAPA No. $ has been completed.

Message: Implementation verification of CAPA: $ CAPA No. $ has been completed.

Interval: Once

Implementation Verification

Not Acceptable

Condition: When Implementation Verification is rejected.

Notify To: Investigation Task Owner

CC: CAPA Coordinator and Implementation Task Owner

Subject: Implementation verification of CAPA: $ CAPA No. $ has been rejected.

Message: Implementation verification of CAPA: $ CAPA No. $ has been rejected with the Comment: $ Rejected Comment $.

Interval: Once

CAPA Plan Implementation

Condition: When Implementation Plan task is routed.

Notify To: Implementation Plan Task Owner (same as Investigation Task Owner)

Subject: Implementation Plan for CAPA: $ CAPA No. $ has been assigned to you.

Message: Implementation Plan for CAPA: $ CAPA No. $ has been assigned to you. Due Date of this Implementation Plan is day task is assigned.

Interval: 1. Once

CAPA Implementation Plan

Approval Routed

Condition: When Approve CAPA Implementation plan task is routed.

Notify To: Approve CAPA Implementation plan Task Owner (same as Investigation Approval Task Owner)

Subject: Implementation Plan Approval for CAPA: $ CAPA No. $ has been assigned to you.

Message: Implementation Plan Approval for CAPA: $ CAPA No. $ has been assigned to you. Due Date of this Implementation Plan Approval is day task is assigned.

Interval: 1. Once

Verification of Effectiveness Routed

Condition: When Verification of Effectiveness task is routed.

Notify To: Verification of Effectiveness Task Owner

Subject: Verification of effectiveness for CAPA: $ CAPA No. $ has been assigned to you.

Message: Verification of effectiveness for CAPA: $ CAPA No. $ has been assigned to you. Due Date of this verification of effectiveness is $ Verification of effectiveness Due Date $.

Interval:

  • When Task is routed
  • 1 day before Due Date
  • 1 day after Due Date to the task owner's manager

Verify CAPA Completion Routed

Condition: When CAPA Closure task is routed.

Notify To: Closure Task Owner

Subject: CAPA closure for CAPA: $ CAPA No. $ has been assigned to you.

Message: CAPA closure for CAPA: $ CAPA No. $ has been assigned to you. Due Date of this closure is $ CAPA Closure Due Date $.

Interval:

  • When Task is routed
  • 1 day before Due Date
  • 1 day after due date to the Task owner's manager

CAPA Closed

Condition: When CAPA is Closed.

Notify To: CAPA Coordinator and CAPA Owner

Subject: CAPA: $ CAPA No. $ is closed.

Message: CAPA: $ CAPA No. $ is closed.

Interval: Once

Task Owner has Changed

Condition: Task ownership is changed.

Notify To: New Step owner

CC: Current Step Owner

Subject: Task Ownership has been changed in CAPA: $ CAPA No. $.

Message: Task Ownership has been changed in CAPA: $ CAPA No. $.

  • New Owner: $ New Step owner$
  • Old Owner: $ Current Step Owner $

Interval: Once

Task has been Reopened

Condition: When any Task gets reopened.

Notify To: CAPA Coordinator

Subject: $Phase$ has been Reopened in CAPA: $CAPA No. $.

Message: $Phase$ has been Reopened in CAPA: $CAPA No. $.

Interval: Once

For additional information, see SmartComm in the SmartSolve Utilities and Settings Help System.

     

 

 
Wednesday, December 4, 2019
11:58 AM