Learn how to:
- Identify key roles in the use of SimplerQMS on every workflow
- Understand and assign User Groups to users
- Assign Site, Project and Classified Document Type Access to users
- Increased understanding of Roles in SimplerQMS
- Increased understanding of Permission and Access levels in SimplerQMS
Prerequisites for all
- Must be logged in to SimplerQMS
- Must be a member of one of these ‘User Groups’ to view records:
- All internal and external users
- Must be a member of one of these ‘User Groups’ to create new records
- All Contributors
Prerequisites for assigning User Groups
- Must have access to the company Azure Active Directory
Prerequisites for making changes to Person Metadata
- Must be a member of one of these ‘User Groups:
- Human Resources
Section 1: Roles
General Roles acting on all Document Classes – also apply to Collections and Quiz
Additional Roles on Change Request and CAPA Classes
Additional Roles on Recorded Issue Document Class
Other system roles
Step 1.1 – Assigning Roles on Documents – Initiator
Role are assigned on every document when the document is being created by any Initiator. The information on documents is always the Workflow Process Information section of the metadata card, except for Templates, where the Template info will contain the roles specific for the template management. Once Create is clicked, the roles can only be reassigned by the appointed Responsible Person or the Process Manager.
Step 1.2 – Reassigning Author – Responsible Person or Process Manager
In the states New Draft and Awaits Updates of Quality Documents, Templates, CAPA, Recorded Issues, Quiz, Collection and the New Draft state of Change Request will be editable, but only the RP and PM can reassign the roles of an Author. This means that changing the Author will require actions from the RP or PM. Newly assigned users will gain instant access to the document, but they will not have it assigned to them due to a change only happening on the metadata without a state transition. To make the necessary changes and reassign the document so that new authors can see it:
I. Click in the author field on the metadata card.
II. Reassign the role.
a. You can add or remove users, or change them out.
III. Save the metadata card.
IV. Click on Reassign to new Author(s) under State Transition.
The document you have updated will be reassigned to the new author(s) who will also receive a notification of their new pending assignment.
Step 1.3 – Reassigning Reviewers under Review Step – Responsible Person and Process Manager
The Responsible Person has the following two options:
Modify Reviewers List
When the document has been routed for a review, and the assigned reviewer(s) need to be changed, the Responsible Person can modify the reviewers list.
I. Click on “Modify Reviewer List” under State Transition.
II. At this stage you can add other reviewer(s), remove, and reassign reviewer(s) on the metadata. You can see this highlighted on the Assignment Description.
III.Once done, click on “Continue Review” under State Transition.
Close Review Immediately
If there are multiple reviewers assigned and one or more reviewer(s) cannot complete their task, the Responsible Person or Process Manager can end the review process without the need for all reviewers to press “My Review Task Completed”.
I. Click on “Close Review Immediately” under State Transition.
II. This will require an electronic signature.
III. The document will be assigned back to the author and can move on to approval.
Step 1.4 – Reassigning Responsible Person – Responsible Person
A new set of responsible person(s) can be set on the object types Supplier, Equipment, Actions and Periodic Tasks in the following editable states:
- Supplier: Pending Classification, Pending Review and Pending Qualification
- Equipment: Pending Classification, Pending Review and Pending Calibration
- Actions: Draft
- Periodic Task: Pending Completion
Newly assigned users will gain instant access to the object, but they will not have it in their Assigned tab and will not receive a notification. To trigger a notification and get the object assigned to the user, make the necessary changes and reassign the object so that new responsible person(s) can see it:
I. Click in the Responsible Person(s) field on the metadata card
II. Reassign the role
a. You can add or remove users, or change them out
III. Save the metadata card
IV. Click on Reassign to new Author(s) under State Transition
The object you have updated will be reassigned to the new responsible person(s) who will also receive a notification of their new pending assignment.
Section 2: Role Relationship Overviews
For step-by-step instructions, visit the relevant work instruction.
Change Request / CAPA
Roles on Recorded Issue Documents
Other System Roles
Refer to the individual work instructions of these items for more detailed instructions and step by step breakdown of what each role will fulfill in the workflow.
Section 3: User groups
User Groups and Descriptions
Section 4: Access in SimplerQMS
The Persons metadata-value is used for providing ownership and access rights of documents and records to specific persons/employees.
Persons can ONLY be created in the Active Directory and thereafter synchronized to M-Files, where they can be managed with other necessary details.
Step 4.1 – Update an existing Person record
When editing any information in the metadata of a person, only the users with the Human Resources user group can make changes. They can edit employee access rights to released and working copy documents as well as edit the employee’s information card – most importantly assign or remove job roles used for setting up learning rules.
I. In the Browse window, on your Home Screen, open the “3. Masterdata Views”
II. Select “Person views”, then the right category you are looking for (e.g., Persons – All) and then choose the person record that you wish to edit. The metadata card of will appear on the right side of the screen.
III. Edit the right fields:
Employee Access Rights to Released Documents
Employee Access Rights to Working Copy Documents
Step 4.2 – Permissions Delegation – Human Resources
In cases where an employee departs from the company or is on extended leave, it’s essential to ensure a seamless transition of responsibilities. You can delegate Author and Responsible Person permissions from one user to another, either on a permanent basis or for a specified period until an expiry date. This delegation can be completed by the Human Resources User Group on the Person metadata card.
I. Access Masterdata Views> Person Views> Persons – All
II. Select the user from whom you want to initiate the delegation. This would be the employee who has departed or is on extended leave.
III. Open the section for “Employee Info – Special Access Rights.” This is where you can manage the delegation of permissions.
IV. Specify the individual to whom the permissions should be reassigned:
a. If the leave is temporary or for a specified duration, you can select an optional expiry date. This ensures that the permissions will automatically revert to the original user after the specified period.
b. If a person has delegated permissions from another user, they cannot delegate their responsibility further. In that case the delegation from another user should be terminated, allowing the reassigning of responsibility from the user.
Employee Info – Special Access Rights
When permissions are delegated, they adhere to the Classified Document Type permissions (see Section 4). This means that if the newly delegated person has not been granted access to a specific document type that is classified, they will not have the ability to view or edit documents on that document type. This security measure ensures that access to sensitive or classified documents is controlled and restricted only to authorized personnel, even when permissions are delegated.
To notify the delegated personnel about the new assigned tasks, the Responsible person or Process Manager of the respective documents and objects can trigger a notification. Follow step 1.2 for documents or step 1.4 for other objects.