New and Improved Features

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PMP-35694 PMP-35694

PMP-56614 As a System Admin I would like to have workflow for Rejected Management Review

Configurable: No

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

Existing System: 

• When Management Review is rejected by a Role system does not trigger any notification to stake holders
• When Management Review is rejected by a Role system does not take the flow back to previous step
• Intimation Notification does not include Comments provided at time of Approval/Rejection

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• When a role Rejects Management Review, previous Management Review role (where status is Complete) status will be set to Re-Open
  • The Re-Open status is not available for manual selection
• Intimation Notification will be triggered for owners of previous role
• If Management Review is rejected by the 1st role then notification would be triggered to Investigation Team by default
• If current Role status is "Reopen", the owner of next role should not be able to perform management review irrespective of mandatory or optional i.e. hide Save button for the next role.

Impacts: Reports

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PMP-35694 PMP-35694

PMP-56616 As a System Admin I want to lock certain fields in FROI and Manage them from Investigation Details

Configurable: Yes

• Title: Display Froi fields in Investigation Questions Section
• Public / Private: Private
• Default: Product: Disabled. Enabled only for FCA

Existing System: 

• Does not have information flow from FROI to Investigation Section and vise-versa 
• Does not have ability to lock certain fields in FROI based on Investigation Details status

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PMP-35694 PMP-35694

PMP-56497 As an end user I would like an option to upload Image for SEWO report sketch box

Configurable: Yes

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

Existing System: 

• Does not have an interface to upload SEWO sketch image in system

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PMP-35694 PMP-35694

PMP-56613 As a System Admin I want to select Investigation Responsibility Team as Management Review owner

Configurable: Yes

• Title: InvestigationResponsibilityShowYN
• Public / Private: Private
• Default: Disabled. Enabled for FCA

Existing System: 

• As of now system does not allow to select a predefined investigation team in Management review
• Each of the users need to be selected once again manually.
• Any change in the investigation team needs to be updated in the Management review

Purpose:

• Make it easy to assign and manage Management Review owners for cases where Investigation Team is the 1st level Management Review team

Enhanced System:

• Has a checkbox available to include Investigation Responsibility Team as Owner in Module Setup as well as Incident Summary >> Role Setup
• If the checkbox is checked for a Role, Investigation team will be included as owners in the Role when Management Review starts
• Any change made in Incident Investigation responsibility team after Management review has started will reflect in Management review once the Role is saved again
• For Management Review Setup screen from Incident Summary, if the check box is unchecked, respective Investigation Team user names will not be removed from Primary owner field. Un-checking the field will only prevent any changes in Investigation Team to reflect in the role

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PMP-35694 PMP-35694

PMP-56407 As an end user I would like to generate SEWO report after detail report status changes to Incomplete

Configurable: No

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

Existing System: 

Purpose:

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PMP-35694 PMP-35694

PMP-7600 As an end user would like to have 12 week CAPA verification process validation

Configurable: No

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

Existing System: 

Purpose:

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PMP-35694 PMP-35694

PMP-56607 As an end user I would like to identify primary root cause for an incident

Configurable: No

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

Existing System: 

Purpose:

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PMP-35694 PMP-35694

PMP-57120 As an end user I would like to capture Asset information as part of Investigation Details

Configurable: No

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

Existing System: 

Purpose:

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PMP-35694 PMP-35694

PMP-57119 Add option to Track action items for each assigned owner individually for IMS Action Items validation

Configurable: No

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

Existing System: 

Purpose:

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