Skip to main content

7. Roles and Rights in CAPA

(1) Roles - General guidelines

Role

Main Purpose

Creator

sets up the CAPA (title, description, source, type); assigns roles

Reporter

is reviewer from the reporting company; confirms remediation; can comment, link and assign

Assignee

executes the CAPA; uploads evidence/remediation; sets status "In Review"

Collaborator

supports execution; can upload files; can comment; can not link findings or change status

Collaborating Company

provides support (e.g. vendor); users inherit rights similar to collaborators

Watcher

is passive observer; can read and comment; cannot edit or upload rights

Shared with Person

is external viewer; can see title, description and remediation proof only

(2) Viewing & Access Rights

Role/Action

Viewing CAPA overview

View evidence

View history

View remediation

Creator

x

x

x

x

Reporting company

x

x

x

x

Responsible company

x

x

x

x

Collaborating company

x

x

x

x

Reporter

x

x

x

x

Assignee

x

x

x

x

Collaborator

x

x

x

x

Watcher

x

x

x

x

Shared with person

-

x

-

x

(3) Editing Core Content

Role/Action

Edit title

Edit description

Upload evidence

Upload remediation

Remediation comment

Comment

Creator

x

x

x

x

-

x

Reporting company

-

-

x

-

-

x

Responsible company

-

-

-

x

x

x

Collaborating company

-

-

x

x

x

x

Reporter

-

x

x

-

-

x

Assignee

-

x

-

x

x

x

Collaborator

-

x

x

x

x

x

Watcher

-

-

-

-

-

x

Shared with person

-

-

-

-

-

-

(4) Role Management

Role/Action

Add/remove
assignee

Add/remove
collaborator

Add reporter

Remove reporter

Add/remove reporting company

Add/remove responsible company

Add/remove yourself as watcher

Add/remove any watcher

Creator

x

-

x

-

-

system-set

x

-

Reporting company

x

x

x

x

-

system-set

x

-

Responsible company

x

-

-

-

-

system-set

x

-

Collaborating company

-

x

-

-

-

system-set

x

-

Reporter

x

x

-

x

x

system-set

x

x

Assignee

x

x

-

-

-

system-set

x

x

Collaborator

x

x

-

-

-

system-set

x

x

Watcher

-

-

-

-

-

system-set

x

-

Shared with person

-

-

-

-

-

system-set

-

-

(5) Linking

Role/Action

Link action

Link finding

Creator

-

x

Reporting company

-

-

Responsible company

-

-

Collaborating company

-

-

Reporter

x

x

Assignee

x

-

Collaborator

x

-

Watcher

-

-

Shared with person

-

-

(6) Dates & Timing

Role/Action

Due date

Created on

Start date

Define due date

Change due date

Date of closure

Creator

x

system-set

x

x

-

system-set

Reporting company

x

system-set

-

x

x

system-set

Responsible company

-

system-set

-

-

-

system-set

Collaborating company

-

system-set

-

-

-

system-set

Reporter

x

system-set

-

x

x

system-set

Assignee

-

system-set

x

x

-

system-set

Collaborator

-

system-set

-

-

-

system-set

Watcher

-

system-set

-

-

-

system-set

Shared with person

-

system-set

-

-

-

system-set

(7) Urgency & Metadata

Role/Action

Define urgency

Change urgency

Impact area

Creator

x

-

x

Reporting company

-

-

-

Responsible company

-

-

-

Collaborating company

-

-

-

Reporter

x

x

x

Assignee

x

-

-

Collaborator

-

-

-

Watcher

-

-

-

Shared with person

-

-

-

(8) Creation Time Fields

Role/Action

Source type

Source

Type

Assignee (at creation)

Reporter (at creation)

Creator

x

x

x

x

x

Reporting company

-

-

-

x

x

Responsible company

-

-

-

x

x

Collaborating company

-

-

-

-

-

Reporter

x

x

x

-

-

Assignee

x

x

x

-

-

Collaborator

-

-

-

-

-

Watcher

-

-

-

-

-

Shared with person

-

-

-

-

-

Did this answer your question?