1. INTRODUCTION

The SoftComply Document Manager (from hereon referred to as “Document Manager”) is a Document Management Application that operates on Atlassian Confluence Cloud.

The Document Manager processes, tracks and manages electronic documents and associated electronic signatures.

2. GLOSSARY

Document

A document is a page and its children in your Confluence instance. Viewing and Editing happens in the standard Confluence views. A document contains all its versions as children items. A document is identified with the information of the version in the following order:

• The latest Released version;
• If no version is Released, the latest Approved version;
• If no version is Approved, the latest Draft version;
• If no version is Draft, the latest Obsolete version.

Each document version is a separate page in Confluence.

Document Version

A Document Version is linked to a single page in Confluence. The editing history of a version is preserved in Confluence using its standard features.

Container

In the Document Manager, Containers are objects that “carry” a document through different states of its lifecycle. Fields and Tasks can be used within Containers to add specific information and ensure all required activities are complete.

In certain cases such as CAPAs, Non-Conformities, Change Requests and Complaints, a Container is not associated to any Confluence page, but the Container becomes a record itself. The sum of all its fields is the content of the record.

Container Template

A Container Template is a “blueprint” of a container. Containers must be created from a template. The Container holds the same field configuration and workflow configuration of the template, but additional setup is required before launch.

NOTE: Once a Container is created from a template, its configuration remains unchanged even when the parent template is modified.

TASK

A Task is an activity assigned to one or more users, that must be completed in a specific step of the workflow, before the Container can transition to the next step.

Tasks can be one of the following types: “Regular” or “Approval”.

A “Regular” task is a general activity that needs to be completed. The assignee(s) can only confirm that the task was Completed.

An “Approval” task involves a decision from the assignee(s). The outcomes are typically referred to as “Approval” and “Rejection”. A Rejection from any assignee immediately triggers the associated transition (if any). A transition triggered by an Approval requires all assignees to Approve all tasks.

“Predefined” tasks are tasks created in a Container Template. When creating a Container, predefined tasks are automatically generated. The owner of the Container can only assign them but not edit or delete them. Predefine tasks can be either Regular or Approval.

3. INSTALLATION and AUTHENTICATION REQUIREMENTS

Software

The Document Manager requires Atlassian Confluence Cloud Standard Plan or higher. The Free Plan does not have user permission management and is not compatible with the Document Manager.

The Document Manager is compatible with the most common browsers. It has been validated on Windows platforms with Google Chrome, MS Edge Chromium and Mozilla Firefox, and on Mac platforms with Google Chrome, Mozilla Firefox and Apple Safari.

The Document Manager is not optimized for mobile use.

Hardware

The Document Manager does not have additional hardware requirements in addition to what is necessary to use Atlassian Confluence Cloud.

Electronic Signatures

In order to execute electronic signatures, a user must have installed a TOTP Authenticator on their personal mobile device.

The Authenticators validated for use are listed in the “User Settings” section of this document.

NOTE: Other authenticators based on TOTP RFC 6238 are likely to work with the SoftComply Document Manager, but the responsibility to validate them resides with the user.

4. NAVIGATION

4.1. ACCESS

The Document Manager can be accessed by users within the Confluence interface, as long as the user is logged into Confluence. In any space click on “SoftComply Document Manager” on the Apps list on the side bar.

You will be redirected to the Dashboard of the Document Manager.

4.2. LANDING PAGE

4.2.1. Top Menu

The Top Menu of the Document Manager contains specific actions and links of the current Module. Each action will be discussed in the relevant section of this manual.

Dashboard option

Returns to the main dashboard view.

Containers option

The link navigates to the container management section of the Document Manager.

In this section the user can see all containers present in the system.

Folders option

This section presents the user a tree view of the documents in the Document Manager. Documents can be arranged in nested folders. The user can create or modify folders and documents from this view.

NOTE: Non-Confluence records such as CAPAs, CRs, etc. are not visible in the Folder view.

Manage option

Users with appropriate permissions can manage Container Templates and Fields.

Manage Container Templates

This view lists all Container Templates in the system. From there Container Templates can be created, edited, made active/inactive and deleted. The user can also view Container Templates and Workflows associated to them.

Only Active templates can be used to create containers.

Manage Fields

This view lists all Fields in the system. Custom Fields can be created and deleted from here.

4.2.2. Side Menu

The Side Menu contains links to the different modules of the system:

• Home: the location of the Dashboard
• QMS: where the QMS documents such as Manual, Policy, Procedures, Templates can be consulted and managed.
• CAPA: Dedicated module for the management of CAPAs.
• CR: Dedicated module for the management of Change Requests.
• Complaints: Dedicated module for the management of Complaints.
• NC: Dedicated module for the management of Non-Conformities.

4.2.3. Create New

From the Dashboard the user can directly create Documents and Containers.

The system presents the user an initial screen that requires basic information such as title, type, description, etc. Once the required fields are populated, the user can proceed to the completion of the document or container.

Create a Document

The following fields are required to create a new document:

FIELD	DESCRIPTION
Document Title	The title that will be applied to the document
Type	It is possible to select the type of document from a predefined list. The selection of the type may constrain the type of container that can be used with the specific document. NOTE: The “QMS Template” document type marks the document as QMS template. This means that the document, when released, will appear in the list of templates available when creating a new document.
Template	It is possible to start the creation of a document using a template. Only documents of “Template” type are available. It is otherwise possible to start from a blank page. NOTE: QMS-type documents can only be created inside the QMS folder. Non-QMS-type folders cannot be created inside the QMS folder.
Folder	The folder where the document will be created.
Start versioning at	The initial version of the document. Default value = 1.
Owner	The owner of the document. By default the current user.
Description	A general description of the document. This description is available in the document details section.

The user can then decide to Create the document or Cancel the creation of the document.

Edit a Document

Documents can be edited using the native Confluence editor.

Create New Container

A modal view allows the user to create a new Container from a Container Template.

The user can then decide to Create the document or Cancel the creation of the container.

After its creation, the user is brought to the Edit Container view.

5. DOCUMENT ORGANISATION: FOLDERS

Access From: Top Menu

In the left panel, the user sees the plain folder structure; folders can be expanded or collapsed. Folders can be moved using a Drag & Drop action.

In the main central panel, the user sees the content of the selected folder and any subfolders. All versions of a document are nested under the main document object.

Available actions for folders:

• Rename: changes the name of the folder.

Available actions for document objects:

• Details: navigates to the Document Details view.
• Move: moves the document to a different location.
• Delete: deletes the whole object. NOTE: this is possible only if there are no Approved, Released or Obsolete versions of the document.

The user can navigate to the “Details” section of a document under the “Actions” column, or by clicking on the name of the document. In this view, all versions of a document are listed with their status and version.

5.1. DOCUMENT DETAILS

This view includes the list of all versions for that specific document.

Each document version reports the document Type, Status and its version. The main document object reports the latest version status.

Available actions for document versions:

• Rename: changes the name of the specific version. Available only if in Draft.
• Duplicate: creates a new document with the content of the selected version.
• Delete: deletes the current version. Available only if in Draft.
• View in Confluence: opens the Confluence page related to that version of the document.
• New Version: creates a new version of the current document, with the content of the selected version. Available only for Released or Approved versions. The button is available in the Top-Right corner of the page. NOTE: this option i

6. WORKFLOWS

6.1. MANAGE WORKFLOWS

Access from: Top Menu → Manage

Currently the user can only view a workflow by clicking on its name or under “Actions”.

6.1.1. Workflow View

In this view, the workflow wireframe is displayed to the user, but it is not possible to modify it.

Steps colour legend:

Grey	Initial step. A container is placed in this step when launched.
Yellow	Intermediate step, neither initial nor final.
Green	Final step. When a container reaches this step, documents become Approved, and if applicable Released.

The view contains also additional information such as:

• Templates where this workflow is used;
• Workflow status;
• Creation date and timestamp;
• Creator;
• Date and timestamp of last edit;
• Last editor.

7. CONTAINERS

7.1. MANAGE CONTAINER TEMPLATES

Access from: Top Menu → Manage

In this view the user can see the following information for each container template in the system:

Name	The name of the template.
Workflow	Workflow used in the template
Status	Draft: the template is incomplete and/or not yet pushed to Active. It cannot be used to create containers. Active: the template is complete and can be used to create containers; Inactive: the template was made inactive. It cannot be used to create containers. Obsolete: the template was made obsolete. It cannot be used to create containers and is not visible to non-admin users.
Type	The type of container. This attribute constraints the type of document that can be linked to a container.

Available actions for each template:

View	Activated from the Action group. It brings the user to the Container Template view.
Delete	Activated from the Action group. The template is deleted. Available only for Draft templates.
Edit	Activated by clicking on the template name. It brings the user to the Container Template edit view.
View workflow	Activated by clicking on the workflow name. It brings the user to the Workflow view.

7.1.1. Create New Container Template

Access from: Manage Container Templates

Users can create custom container templates, clicking on “Create container template” in the Container Management view.

A number of information is required to create a new template. The template “Type” affects where the containers created from this template are displayed for “Non Conformity”, “CAPA”, “Change Request” and “Complaint” types (e.g. a “Change Request” container will be listed in the CR view of the system).

Once the user selects the workflow, its layout is displayed in the right section of the view.

NOTE: Currently only predefined workflows can be associated with a template.

Clicking on the “Create” button will generate a new template and the user is presented with the Edit view (see “Container Template edit” section of this document). “Cancel” brings the user back to the Container Management View.

7.1.2. Edit Container Template

In this view the user is allowed to edit the configuration of the container template.

A – Workflow

The user can select the workflow associated with the template.

NOTE: Only one active workflow can be associated with a Container Template. Changing the associated workflow will result in the resetting of all Workflow, Container and Fields configuration as many options depend on the workflow logic and steps.

B – Template Status

The user can change the status of the template. Only Draft templates can be edited and only Active templates can be used

C – Field configuration tab

In this tab, the user can customize the fields contained in the template.

C1 – When editable

The user can select in which steps this field is editable.

If “Always” is selected, the step list is not available.

C2 – When required

The user can select in which steps this field is required. Transitions are not available if this fields is not filled in.

NOTE: If a field is “required” in a step, it must also be “editable” in the same step.

C3 – Save fields configuration

NOTE: The settings of each tab must be saved separately, using the save button at the bottom of the tab.

C4 – Add new field

The user can add a new field in the template, from the list of Active fields.

D – Close

The view will close without saving the settings.

E – Workflow configuration tab

In this tab the user can define the behaviour of each step of the workflow. The user must select each step of the workflow by clicking on it and set up all options.

E1 – Workflow diagram

The user can select each step of the workflow to apply the settings in the “Task” and “Behaviour” tabs.

E2 – Tasks Tab

In this tab the user can define the parameters of tasks assigned to the specific step, and create predefined tasks if necessary.

E3 – Allow task creation in this step

If selected, users are able to create tasks while in the current step, when a container is routing.

E4 – E-signatures required

If selected, the completion of any task in the step requires electronic signatures.

E5 – Approval step

If selected, all tasks in this step must be of the “Approval” type, i.e. with “Approved” and “Rejected” outcomes. If not selected, only standard tasks are allowed, i.e. tasks that simply need user confirmation of their completion.

E6 – Allow document editing in this step

If selected, assignees can edit documents linked to the Container in this step.

E7 – Predefined tasks

The user can add or remove predefined tasks. A predefined task is a task that is automatically created in a container generated from this template and cannot be removed or modified by the user, only assigned.

When “Add new task” is selected, the user is prompted to enter task name and description.

“Reset” option: if selected, all approval of a task are wiped if the container returns to that step.

NOTE: Approval tasks are always reset

FOR EXAMPLE: Two tasks are created in step X, task A and task B. Task A is approved while task B is rejected. The container returns to a previous step and eventually reaches step X again. When the “Reset” option is selected, both tasks A and B are re-assigned and have to be completed again. If not selected, only task B is re-opened.

Predefined tasks can be removed once created only from the container template.

E8 – Behaviour Tab

E9 – Event

• Expiry (triggered only if a due date is set up); only one transition can be selected;
• Approved (for Approval-type steps): what is triggered when all tasks are approved; only one transition can be selected;
• Rejected (for Approval-type steps): what is triggered when any task is rejected; only one transition can be selected;
• Task Completed (for standard-type steps): what transitions are made available when all tasks are complete; multiple transitions can be selected.

E10 – Transition to

The Transition that is triggered (or made available) when the event occurs. If a transition is not associated with any event, it can be manually triggered at any time.

Only transitions outbound from the selected step are listed.

7.1.3. Container Template View

Access from: Manage Container Templates, from the Actions column or clicking on the template name and the template is not editable.

The view is identical to the Container Template Edit view, but no file is editable.

7.2. MANAGE CONTAINERS

Access from: Top Menu

In this section the user can see all containers present in the system.

For each container, the system reports the Type, ID, Time in step, Workflow step (Draft if not launched), Owner and Pending Tasks (if any). The user can navigate to the Task View of the Container by clicking on the task number list.

Available actions for each container:

• Edit: link to the Edit view of the containers;
• View: link to the View view of the containers;
• Delete: deletes the current container. Note that this is only available if the content is in DRAFT status.

The user can also create a New Container clicking on the “Create Container” button. See New Container section below for details on the creation of a new container.

7.2.1. Create New Containers

The following fields are required to create a new container:

Field	Description
Name	The name that will be assigned to the container.
Type	It is possible to select the type of container from a predefined list. The selection of the type may constrain the type of documents that can be added to the container.
Template	A container must be created from an Active Container Template.
Owner	The owner of the container. By default the current user.
Description	A general description of the container.

The user can then decide to Create the document or Cancel the creation of the container.

After its creation, the user is brought to the Edit Container view.

7.2.2. Edit Containers

Access from: Top Menu → Containers → Actions → Edit

NOTE: Only Draft and Active containers can be edited

In this view the user can see the content of the container, documents and tasks and edit them.

Certain fields such as Name, Status, Workflow, Type, Template are not editable.

Editing a Container Before launch

The user can add, customize and assign tasks. The user can also add and remove documents.

From this view it is also possible to Launch the Container. A container can be launched only if all tasks have been assigned

Add and remove documents from a container

1. Select the “General” Tab in the Edit Container view;
2. Click on the “+ Add” button;
3. Start typing the name of the document to be added; NOTE: In order to add a document version to the Container, this version must be Draft and not linked to another running container.
4. Select “Add”.

The document and its draft version are now listed in the Container.

Task Management in Container before Launch

Before launch, the Owner of the Container must assign at least one user to each predefined task (if any).

NOTE: Only users who have access to the App and have already activated the App can be selected.

You can also create additional tasks by clicking the “+ Add new task” button.

Unlike with the Predefined tasks, assignees must be defined immediately as the task is being created.

Editing a Container After Launch

Assignees can edit fields as per the logic set up in the container template. Only fields marked as editable in this step can be edited.

Owners of Containers can edit existing tasks as long as they are not yet completed. Owners can also add new tasks if the “Allow task creation in this step” option was selected during the Container Template setup.

7.2.3. Launch a Container

A Container can be launched only by the Owner and only if all required fields are populated and all tasks have assignees.

The Status of the container becomes “Active” and the Workflow step indicates the current step in the Workflow.

7.2.4. View Containers

Access from: Top Menu → Containers → Actions → View

The user can view the configuration and content of fields and the status of the tasks. No field or task can be edited.

7.2.5. Container Lifecycle

Task Completion

Tasks that are assigned to the current Container step can be completed by the assignee(s).

The “Completion” option allows the user to enter Completion Information about the task. This is usually required to describe how the task was completed and to provide the necessary evidence.

NOTE: The “Assign” and “Remove Assignees” buttons are available only to the Owner of the Container.

Completing a task may require the e-signature depending on the setup of the task.

Transitions

Transitions will be triggered automatically if it has so been configured in the Container Template, otherwise the Owner can trigger them manually once all tasks are completed and required fields filled in.

Please note that it may take a few seconds for the transition to complete.

Final step and Release

Once the container reaches the final step (green step), all fields are locked. All linked documents move the “Approved” status. If selected, the user can then Release the container.

Released documents are publicly available, while documents in the “Approved” status may still be subject to some access restrictions.

ABORTING A CONTAINER RUN

In any step of the workflow except the final step, the container owner can abort the run of a launched container. This action requires an electronic signature and justification to be completed.

Once aborted, a container enters the “Aborted” status. From this status the container can be deleted if necessary.

NOTE: document versions linked to an aborted container cannot be linked to a new one. In order to do this, delete the aborted container or remove the documents from it.

8. FIELDS

8.1. MANAGE FIELDS

Access from: Manage Container Templates

From this view the user can browse the existing fields or create new ones.

8.1.1. Create New Fields

The user can create a new filed entering its name, a description and selecting the field type:

FIELD TYPE	DESCRIPTION
TEXTFIELD	Short Text field.
NUMBER	Decimals, including negative.
USER_SELECTION	Selection of Atlassian user from a list.
TEXTAREA	Large text field (4000 characters max).
CHECKBOX	Checkbox, ticked/unticked, one option. The option must be defined at setup.
MULTI_CHECKBOX	Checkbox, ticked/unticked, multiple options, multiple selections allowed. The options must be defined at setup.
SELECT	Single select from a predefined list of values. The values must be defined at setup.
MULTI_SELECT	Multi select from a predefined list of values. The values must be defined at setup.
RADIOBUTTON	Checkbox, ticked/unticked, multiple options, single selection only. The options must be defined at setup.
URL	Text with valid URL value
DATE	dd/mm/yyyy
DATETIME	dd/ww/yyyy hh.mm
TIME	hh.mm

9. USER SETTINGS

Access from: Side menu

The user can review the status of his/her signing token. This token is use as “secret” to execute electronic signatures in the system.

9.1. SETUP OF AUTHENTICATOR

If a user does not have a paired authenticator, the following view is displayed:

Clicking on “Enable signing” starts the process to pair an Authenticator installed on a Mobile App with the SoftComply Document Manager.

The System will generate a QR code. This code is unique for each user and is based on the user currently logged into the system. The user must scan it with an Authenticator installed on a mobile device to create a new account. A 6-digits code is then generated by the App and refreshed every 30 seconds. This is the token used to execute electronic signatures in the SoftComply Document Manager.

9.1.1. Validated Authenticators

The following authenticator have been validated for use with the SoftComply Document Manager:

1. Google Authenticator
2. Microsoft Authenticator

For both Android and iOS platforms.

9.2. MANAGE E-SIGNATURE TOKENS

When set up, the user can visualize the relevant information about the e-signature token, such as setup date, last attempt and number of failed attempts.

The use can Reset the token by pressing “Reset signing”. The paring with the Authenticator is sieved and the user cannot execute electronic signatures until the pairing process is completed again.

9.3. IMPORTING EXISTING PAGES

For the DM to be able to manage existing Confluence pages, these pages must be moved to the Spaces controlled by the DM. The App cannot control pages outside these spaces.

From the left panel, select “Settings” then “Import Documents”.

From the import view, select the Space you want to import and the destination folder for the pages.

The DM will import the page in the background. The time required to import pages depends on their number and content. As a rule of thumb, expect 1 minute for every 10 pages.

Important notes regarding the import of pages into the DM

1. All pages in a space are imported. If you do not want to import certain pages, please move them to a different space.
2. Pages to be imported are MOVED, not copied, to maintain the current links. For this reason it is strongly recommended to BACKUP THE SPACE before import.
3. Imported pages DO NOT MAINTAIN THE HIERARCHICAL STRUCTURE once imported. The system does not know if a parent page is used only as a folder or if it is a document too. Users will have to rearrange the imported pages as appropriate within the Folder view of the DM.
4. A maximum of 200 pages can be moved at once. You can import the remaining pages after the previous import has been completed, repeating the process described above. Pages not imported remain in the original space.