Getting Started Archive - SimplerQMS Knowledge Base https://www.simplerqms.com/article-categories/getting-started/ Ready-to-use eQMS for Life Science Thu, 19 Oct 2023 21:47:27 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.2 https://www.simplerqms.com/wp-content/uploads/2020/09/SimplerQMS-Logo-300x300-1.png Getting Started Archive - SimplerQMS Knowledge Base https://www.simplerqms.com/article-categories/getting-started/ 32 32 SimplerQMS – Onboarding & Offboarding https://www.simplerqms.com/knowledge-base/simplerqms-onboarding-offboarding/ Mon, 01 May 2023 13:03:13 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=248737 This work instruction is only for the onboarding of new users in SimplerQMS and offboarding users. Purpose Expected Outcome Prerequisites Overview of Responsibilities Step Task Owner 1 Before new user starts Employee Manager/HR/IT/QA 2 New user’s first day of use of SimplerQMS User/Training 3 Offboarding user Employee Manager/HR/IT Step 1 – Before a New User […]

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This work instruction is only for the onboarding of new users in SimplerQMS and offboarding users.

Purpose

  • Provide guidance on how to set up new users in SimplerQMS.
  • Provide guidance on how to deactivate users in SimplerQMS.

Expected Outcome

  • Organized onboarding and offboarding instructions in SimplerQMS

Prerequisites

  • Access to the company Azure Active Directory – to create/ remove user.
  • Access to SimplerQMS with user groups All Contributors, Training Manager and Human Resources – documentation, training
  • New User access with at minimum Read & Sign (for Read & Sign license) or All Contributors (Concurrent + Named License) User Groups

Overview of Responsibilities

StepTaskOwner
1Before new user startsEmployee Manager/HR/IT/QA
2New user’s first day of use of SimplerQMSUser/Training
3Offboarding userEmployee Manager/HR/IT

Step 1 – Before a New User Starts

Step 1.1 – Access Request Form

I. Employee Manager/HR/IT/QA confirms that a new user should be set up in SimplerQMS

a. Create an access request document based on the access request template implemented in the system; the template was first established at the beginning of SimplerQMS implementation. If there was no template, reach out to SimplerQMS team for guidance.

b. Access request form should contain; Log in information (except the password), user groups, Sites, training groups, projects & classified document types if there are any.

c. Employee Manager/HR/IT/QA sends the access request document to the person responsible for creating users in Azure Directory.

Step 1.2 – Create User in Azure Directory

I. Azure Directory responsible receives the access request document for the new user.

II. Follow the instructions on how to add users in Azure: https://www.simplerqms.com/knowledge-base/creating-new-users-in-azure/

III. Notify the Employee Manager/HR/IT/QA that the user has been added to Azure according to the access request document.

Step 1.3 – Update New user in M-Files

I. The Employee Manager/HR/IT/QA notifies SimplerQMS to assign a license to the new user.

Note: For some customers with concurrent license, the new users are set to a default concurrent license which is set up in Azure, if there is no concurrent license in your company or if concurrent license is not the license to assign to the user, reach out to SimplerQMS.

II. The Employee Manager/HR/IT/QA (with Human Resource user group) assigns the Site (in both working copy and released documents). It is advised that the Site access is only modified during off hours as the permissions recalculate for all the users on all documents when a change is made.

III. The Employee Manager/HR/IT/QA (with Human Resource user group) assigns the Project and/or Classified Document types, if there are any.

IV. The Employee Manager/HR/IT/QA (with Human Resource user group) assigns the training groups to the new user. Once the training groups have been assigned, the learning records should start to assign to the new user automatically.

Note: The new user will appear in M-Files 15 to 30 minutes after they were created in the Azure Active Directory.

Step 1.4 – Prepare Electronic Signature Agreement

I. The Employee Manager/HR/IT/QA creates an electronic signature agreement document based on the electronic signature agreement template implemented in the system. The template was first established at the beginning of SimplerQMS implementation. If there was no template, reach out to SimplerQMS team for guidance.

II. Print a copy of the electronic signature agreement and ask for a written signature from the new user.

Step 1.5 – New user signs Electronic Signature Agreement

I. The new user receives a hard copy of the electronic signature agreement.

II. Signs the document with and returns the document to the Employee Manager/HR/IT/QA

III. Employee Manager/HR/IT/QA create a scanned copy, drag and drop it onto the original ESA document within SimplerQMS associated to the user and send for approval.

a. It is advised that the ESA document also gets approved (signed) in SimplerQMS by the new user, so their electronic signature is also present on the document with their physical signature.

Section 2: New user’s first day of use of SimplerQMS

Step 2.1 – New user’s access in SimplerQMS

I. The Employee Manager/HR/IT/QA shares the following information to the new user

a. Email and password to access SimplerQMS

b. Installation instructions for the Production Vault:

For Windows: https://www.simplerqms.com/knowledge-base/installing-simplerqms-m-files-on-windows-and-adding-production-vault/

For Mac: https://www.simplerqms.com/knowledge-base/getting-started-with-simplerqms-m-files-in-chrome-web-browser/

c. Vault connection server name (can be found in M-Files Desktop settings on a computer with M-Files installed for Windows or for Mac, access the vault using Chrome and share the link to the new user)

II. The new user receives necessary information to acquire access in SimplerQMS

III. Use the log in information shared by the Employee Manager/HR/IT/QA. The new user should now have access to SimplerQMS.

IV. Approve the Electronic Signature Agreement if assigned using the login information

Step 2.2 – New user reads and signs learning records

I. New user starts receiving notifications about the training records, reads the documents and signs electronically.

II. The learning records can be found in the Assigned section of SimplerQMS

a. Click the expand arrow to see the Versions to Learn

b. Once you are done reading the document, click on the assignments (Training Record) and click “Read ad Understood under the State Transition

Note: To know more about Training Records refer to Section 3, 4 & 5 of this link: https://www.simplerqms.com/knowledge-base/managing-training-and-learning/

Section 3 – Offboarding a User

Step 3.1 – IT Department Notification

I. Manager notifies IT that user is leaving to ensure that the access rights of the departing employee will be revoked on the last working day

II. IT deactivates user in the Azure AD on the last working day

a. The minimum requirement is to set the user as Disabled

Step 3.2 – SimplerQMS A/S Notification

I. Notify SimplerQMS A/S to remove the license from the departed user

Step 3.3 – Human Resource

II. The Employee Manager/HR/IT/QA (with Human Resource user group) of the company sets user to “Former employee”

a. This happens automatically if the IT has changed the user to Disabled, but it is important to be verified by the HR User

Step 2.3 – Reassigns tasks to an active user

If the departing user has documents or tasks assigned and still on editable state, follow the steps below to reassign these documents or tasks to an active user

I. The metadata administrator should reassign Responsible person or manager to objects such as departments, sites, processes, document types etc., to an active user.

II. Check any documents that are still on editable state if assigned to the former user, ensure that it will be reassigned to an active user

a. Go to Masterdata Views, double click to open, then select the Content Views and Content by Person (Current Only)

b. Select the former employee’s name and find the documents that are in this state:

i. New Draft

ii. Awaiting Updates

iii. Review ongoing

iv. Awaits Approval Signature(s)

III. Assignments to the former user such as Periodic Reviews, Supplier Qualifications, Equipment Calibration and Open CAPA and effectiveness assessment schedules should also be checked to ensure that it will be reassigned to an active user to continuously monitor these active assignments.  You can reach out to SimplerQMS if unable to perform these tasks.

IV. Retire or update the electronic signature agreement and the access request form of the former employee.

Note: If the Metadata Administrator leaves the company, reach out to SimplerQMS Implementation & Training Team for further assistance

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Installing SimplerQMS M-Files on Windows with the Sandbox Vault https://www.simplerqms.com/knowledge-base/installing-simplerqms-m-files-on-windows-and-adding-sandbox-vault/ Mon, 27 Feb 2023 15:05:09 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=247534 Purpose Installing M-Files on a PC. Step 1 – Download the M-Files Installation Package                  Go through the following steps to install SimplerQMS M-Files:Open a web browser and go to www.simplerqms.com/test You will be redirected to our file share on SharePoint.  Download the installation package: After you have downloaded the installation package, you might see different […]

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Purpose

Installing M-Files on a PC.

Outcomes and Prerequisites

Outcomes

M-Files Application for SimplerQMS has been installed on a PC.

Prerequisites

The PC must comply with the system requirements, see https://www.m-files.com/user-guide/latest/eng/operating_system_requirements.html

Step 1 – Download the M-Files Installation Package                 

Go through the following steps to install SimplerQMS M-Files:
Open a web browser and go to www.simplerqms.com/test

You will be redirected to our file share on SharePoint. 

Download the installation package:

After you have downloaded the installation package, you might see different warning messages such as these:

Click Keep and then Keep anyway.

Then Run the installation package.

You might see this message:

Click More info and Run anyway.

Step 2 – Install the M-Files Online Application              

The M-Files Installation Wizard will appear:

  1. Click “Next”. The End-User License Agreement will now appear.
  2. Select “I accept the license agreement” and click “Next”
    • Depending on your Windows version and setup, the following dialogue box might appear: “Do you want to allow this app to make changes to your device?” Click Yes. M-Files will now start installing.
  3. You will then see: “M-Files has been successfully installed.”
  4. Untick the checkbox “Start M-Files Desktop configuration.”
  5. Click Finish.

Step 3 – Login to SimplerQMS / M-Files

Note: You will only be able to complete this step after receiving your login credentials from SimplerQMS.

You should now see a Microsoft Log-in window:

If you don’t see this window, then go to your desktop and click the M-Files icon.

1. If you previously used another Microsoft account, then click “Use another account”

2. Log in using the credentials you receive from our team members

  • Look out for the following:
    • The email address should end in “@simplerqmstest2.com”

3. Wait for this dialogue box to appear (this can take up to 20 sec.):

Click Allow. The M-Files Applications has now been installed and will now open.

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Installing SimplerQMS M-Files on Windows and Adding Production Vault https://www.simplerqms.com/knowledge-base/installing-simplerqms-m-files-on-windows-and-adding-production-vault/ Mon, 30 Jan 2023 08:49:56 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=247262 Purpose Installing M-Files on a PC. Step 1 – Download the M-Files Installation Package                  Go through the following steps to install M-Files: Open a web browser and go to www.simplerqms.com/m-files. You will be redirected to our file share on SharePoint.  Download the installation file and run it: Step 2 – Install the M-Files Online […]

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Purpose

Installing M-Files on a PC.

Outcomes and Prerequisites

Outcomes

M-Files has been installed on a PC.

Prerequisites

The PC must comply with the system requirements, see https://www.m-files.com/user-guide/latest/eng/operating_system_requirements.html

Step 1 – Download the M-Files Installation Package                 

Go through the following steps to install M-Files:

Open a web browser and go to www.simplerqms.com/m-files. You will be redirected to our file share on SharePoint. 

Download the installation file and run it:

Step 2 – Install the M-Files Online Application              

The M-Files Installation Wizard will appear:

  1. Click “Next”. The End-User License Agreement will now appear.
  2. Select “I accept the license agreement” and click “Next”
    • Depending on your Windows version and setup, the following dialogue box might appear: “Do you want to allow this app to make changes to your device?” Click Yes. M-Files will now start installing.
  3. You will then see: “M-Files has been successfully installed.”
  4. Leave the check box checked “Start M-Files Desktop configuration.”
  5. Click Finish.

Step 3 – Adding a New Vault          

You should now see the following box:

Click Add

If you don’t see the M-Files Desktop Settings box as shown above, then right-click on the M-icon in the Windows Hidden Icons Tray at the bottom right of your screen. Then click Settings > M-Files Desktop Settings.

Step 4 – Setting up your Production Vault

This setup is for your active effective environment. This vault is only accessible by members of your organization and log-in is controlled by your Azure Active Directory.

  1. After hitting “Add” on the M-Files Desktop Settings, input the following information:
    • Name: [Company Name] Production (or any name you see fit for your daily use)
    • Server Name:  [companyname].cloudvault.m-files.com*
    • Port Number: 443
    • Protocol: gRPC
  2. Test the Connection by clicking on “Test Connection”
    • this should say it succeeded to confirm that all the details above are correct
  3. Set the Authentication to:Current Windows User
    • If you are not logging into your computer with your company credentials (fx name@company.com), then you need to set Authentication to: Specific Windows User. Please ask your IT-administrator or SimplerQMS Support if you are in doubt about this.
  4. Remove the Check mark in “Log in automatically when Windows is started”

*Replace “companyname” with your organization’s name. If you do not have the correct link, reach out to us and we will provide it.

5. Click on the empty drop-down next to “Vault on Server”.

6. The system should log in automatically as it is using your company email address and password. If not, a Microsoft Log-in window will open:

7. Log in using you company account (first option on the Microsoft Log-in window)

8. After log-in the “Vault on the server” will display your own vault titled “[Company Name]”. Select this option

9. Click OK to save the Vault Connection

10. Click Close to close the Vault Connections box

Step 5 – Start M-Files Online

Start the M-Files application by clicking on the M-Files desktop icon. 

Select the vault you wish to log into.

Enter the username and password again. (if prompted)

Wait for this dialogue box to appear (this can take up to 20 sec.):

Click Allow. The M-Files Applications has now been installed and will now open.

Step 6 – Automatic Check-in

When a users has worked with a document in Office, then M-Files will by default ask the user if the document should be Checked In, when the document is closed. We recommend that you enable automatic check-in of documents, to make this process easier for the user. This is done in the following way:

1. Go to M-Files Desktop Settings and choose the “Settings” tab.

2. Click User-specific Settings

3. Select “Check in immediately” in the “Behavior at file close” section and click OK

Documents will now be checked in automatically each time you close them, ensuring that no documents stay checked out to you and can easily be accessed by other users of the system, and mitigating the risk of information loss.

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Accessing SimplerQMS M-Files Mobile https://www.simplerqms.com/knowledge-base/accessing-m-files-mobile/ Wed, 14 Dec 2022 09:39:03 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=247171 SimplerQMS is also available through the M-Files mobile application for iOS and Android devices. With the mobile applications, you can see vault content, mark your assignments complete, and create and share objects. You can download the latest version of the mobile applications from your application store: Logging in to SimplerQMS M-Files Mobile 1. Open the SimplerQMS M-Files mobile app on your device. […]

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SimplerQMS is also available through the M-Files mobile application for iOS and Android devices. With the mobile applications, you can see vault content, mark your assignments complete, and create and share objects.

You can download the latest version of the mobile applications from your application store:

Logging in to SimplerQMS M-Files Mobile

1. Open the SimplerQMS M-Files mobile app on your device.

2. Click on the “+” for Vaults

3. On the login screen, enter the full server address.

Example: If the name of your vault is SimplerQMS, the address will be https://simplerqms.cloudvault.m-files.com

4. Click on “Connect

5. Enter your username and password.

6. Tap Sign in.

You are now logged in and you see the SimplerQMS M-Files home screen.

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Creating New Users in Azure Active Directory https://www.simplerqms.com/knowledge-base/creating-new-users-in-azure/ Wed, 14 Dec 2022 09:00:46 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=247168 To create new users in Azure Active Directory and assign Groups, follow these steps: 1. Log in to Microsoft Azure Active Directory 2. Click on “User” 3. Click on New User at the top of the page then “Create new user” 4. Fill-out Username and Name. For password choose the option for “Auto generate” then […]

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To create new users in Azure Active Directory and assign Groups, follow these steps:

1. Log in to Microsoft Azure Active Directory

2. Click on “User”

3. Click on New User at the top of the page then “Create new user”

4. Fill-out Username and Name. For password choose the option for “Auto generate” then copy. Log in information will need to be provided to the new user and on their first log in, they will have the opportunity to change their password.

5. Click on “Groups” to add Groups relevant to the user. Groups will depend on what kind of access the new user will need to have.

6.  Job info can also be filled-out then click on “Create”

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Working with SimplerQMS / M-Files https://www.simplerqms.com/knowledge-base/working-with-m-files-simpleqms/ Fri, 07 Oct 2022 12:18:38 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=245685 Purpose Learn how to: Expected Outcome Prerequisites for all Section 1: Learn about M-files and SimplerQMS M-Files is a document management system, which can be designed into a platform for different services. SimplerQMS configured M-Files into the eQMS system that you know today and continuously validates the software to stay compliant. Features have been specifically […]

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Purpose

Learn how to:

  • Set up/install M-Files/SimplerQMS application on a Windows platform
  • Get around M-Files/SimplerQMS application on a Windows platform
  • Navigate and learn the basic functions

Expected Outcome

  • Users are equipped to handle basic functionality of M-Files in SimplerQMS

Prerequisites for all

  • Must be using Windows to use the application
  • For Mac users, must have Chrome browser installed
  • 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 view records:
    • All Contributors

Section 1: Learn about M-files and SimplerQMS

M-Files is a document management system, which can be designed into a platform for different services.

SimplerQMS configured M-Files into the eQMS system that you know today and continuously validates the software to stay compliant. Features have been specifically engineered to service the needs of customers in the medical device and pharmaceutical industry, laboratories, and small consultancies.

If you would like to get to know more about M-Files, visit this link: https://www.m-files.com/about/  

Section 2: Install M-Files and Add Vault Connection on Windows

The M-Files desktop application is ONLY compatible with Windows computers. To get started with installing the M-Files/SimplerQMS application, follow the instructions from this guide:

For training vault: https://www.simplerqms.com/knowledge-base/installing-m-files-on-windows-adding-connection-to-test-environment/

For production vault: https://www.simplerqms.com/knowledge-base/installing-simplerqms-m-files-on-windows-and-adding-production-vault/

Section 3: Setting up M-Files in Chrome Browser

If you are using a different operating system other than Windows, M-Files can be accessed through Chrome. To get started, follow the instructions from this guide:

https://www.simplerqms.com/knowledge-base/getting-started-with-simplerqms-m-files-in-chrome-web-browser/

Section 4: Using M-Files on Mobile (Android and iOS)

For an on-the-go solution, you can install M-Files on your mobile device. With the mobile applications, you can see vault content, approve documents, or mark assignments complete, and create or share objects.

Section 5: Accessing M-Files/SimplerQMS on a Windows PC

Once you have installed the M-Files application and added your company’s vault connection, you can start using SimplerQMS in M-Files.

There are multiple ways to access SimplerQMS:

I. On your desktop, double- click on the M-Files application.

II. Using the file explorer navigate to This PC. A new drive is created for M-Files when the application is installed. Double-click on the drive.

III. On the lower right of your screen, access hidden icons (the arrow pointing up) and doble-click on the M-Files logo.

Using either option, once you have accessed the system you can get started with using SimplerQMS.

Section 6: Interface

The SimplerQMS interface is built up by 4 main components:

A. Task Area – contains the Create section and all Main Views. This is the area where Actions and State Transitions will appear as well.

B. Search bar and Main Navigation Tabs – for quick search. This area also contains the Create button which you can use to create records and items in the system.

C. Listing Area – By default opens to the All tab containing the main navigation views. Top section contains all common navigation panes like Recent, Assigned, Checked Out and Pinned.

D. Right Pane – By default it opens on Dashboard, showing personalized reports of your pending and overdue tasks, trainings and documents.  

  1. You can also access the Help tab (Section 8) from this section.
  2. When a record is clicked, the Metadata (Section 9), Preview (Section 10) or Workflow (Section 11) can be accessed from here.
  3. Filters will activate when you start using the Quick Search bar (Section 12).

Tabs on the center Listings Area:

I. All – contains 3 view categories

1. My views – contains all the views which focus on all items in the system related to you in some way – e.g. All Documents Related to you, All Tasks and Assignments Related to you

2. Main views – the core views for navigating the system, such  as All Documents, Quality Manual, Equipment, Suppliers etc. – this is replicated on the Task Area as well under the Go To section

3. Masterdata views – Contains all system elements that are managed by the Metadata Administrator. As a general user, this view gives you access to the structure of your system, containing the list of Sites, Departments, Processes, Departments and more.

4. Other views – Assigned to Me, Checked Out to Me, Recently Accessed by Me and Pinned from the top bar. Favorites (discontinued feature) and Offline are also located here.

II. Recent or Recently Accessed by Me – access to documents or objects that a user has accessed within the past 30 days.

NOTE: If you wish to remove an object from this view, right-click on it then select Remove from this View.

III. Assigned to Me – documents or objects in this view are assigned to you either as author, reviewer or approver, responsible person or trainee. You also receive an email notification about the document or object that is assigned to you depending on the vault’s notification settings. The tab will also mark how many items are pending in your assigned to me.

IV. Checked Out to Me – this view will show the documents that are currently checked out to you. It is very important that at the end of a workday this section is completely empty as every document checked out to you will only save changes once it is checked back into SimplerQMS. (Refer to Section 20)

V. Pinned

Think of this as a desktop within SimplerQMS. Pinned allows you to collect items that you frequently use into a single tab. It is a collection of shortcuts that provides quick access to your most accessed resources.

You can pin anything within the system that you would like to access quickly. You can still navigate the system while the Pinned view is open, so finding the relevant object and adding and organizing them is possible at the same time.

Adding items to Pinned can be done either from the metadata, using the pin button, or by right clicking on an item inside and clicking on Pin.

These items can be easily unpinned by right-clicking and selecting Unpin.

Inside Pinned you can create groups so you can categorize the shortcuts into areas of their own. Use the button to add more groups. You can collapse or expand, rename or remove groups as well by clicking on the  button.

You can also search specifically within the pinned tab if you have added many different elements and need to find them quickly.

Section 7: Home Dashboard

Upon logging in, you will be shown the Home Dashboard. This is a personalized hub providing immediate access to critical metrics. These help you effectively navigate and utilize key views and showcasing actionable insights into your work within SimplerQMS.

You can always navigate back to the Dashboard as well by clicking on the dashboard tab in the Right Pane.

Please note that this feature is currently only available on the Windows Client of SimplerQMS.
You don’t need to navigate through multiple menus or lengthy lists. Each tile on the Home Dashboard represents a specific view. To address pending items, simply click on the relevant tile. This will navigate you to the view where you can tend to the pending or overdue tasks, training records or review and sign pending documents:

The Home Dashboard provides real-time updates, ensuring that you have immediate visibility into the latest assignments that require your attention. Stay informed and respond promptly to new tasks and responsibilities as they arise.

You can also manually refresh the dashboard each time you suspect new assignments became available. Click on Refresh Data to view the latest updates on your assigned tasks:

Section 8: Helpdesk/Support

Within SimplerQMS you can easily access our Helpdesk and Emergency Contact options, as well as our Knowledge Base full of useful articles and Work Instructions.

To do this, click on the Help Tab in the Right Pane.

From here you can directly email our support mail which will redirect your inquiry into our Helpdesk Portal. You can also access the Portal directly and ask your questions there.

For answers on our frequently asked questions and to locate our work instructions, take a look at our Knowledge Base.

In case of big emergencies, reach out to us via the phone number you see on the Help tab.

Section 9: Metadata Card

Metadata is the backbone of SimplerQMS. All documents and objects within the system are tagged with metadata. This makes it easier to find the information you are looking for within the vault. Regardless of the way documents are saved to M-Files, you must always fill in the metadata card prior to creating / filing the document.

On the next page you will see a sample metadata card of a quality document. The metadata card is dynamic and will always include different fields based on the item’s Class.

1. Title – The full title of the document.

2. Status – this section includes creation, modification, check-out, and signature related information.

3. Assignment Information – Includes the Assignment Description, which guides you through the workflow step by step. Also shows who the item is assigned to.

4. Document Information – Values defined at creation used for the title and filtering.

5. Change Control – provides details whether a document requires Change Request and Periodic Review. (This section is not present on all documents)

6. Workflow Process Information – contains assigned roles for this document, due date, effective date and review and approval information.

7. Approval and Reviewer Information – remaining and completed reviews and approvals.

8. Relations – relations to other items, standard chapters, parent document and template.

9. System Information – additional information – includes a description field for additional information and migration reference fields if you wish to refer to your paper records.

10. Permission, Workflow & State – this area describes user access to the record, workflow applied, and the current state of the document.

NOTE: The full title of documents in SimplerQMS consists of the Document Type + Unique ID assigned by the system + Short Title + Major Version Number.

The unique ID will at first consist of 5 digits but will increase after you have surpassed that number of documents.

The Metadata Card also includes a light blue bar, which changes between green (approved) and red (archived or retired) to visualize different states of documents. Regardless of the color, this section includes very useful buttons:

  Open history (audit trail)

  Flagging an item will turn on notifications, so as it progresses through the different workflow steps you will be notified each time a change is made.

Pinning an item will add it to the Pinned Tab (Section 9).

This icon will open the metadata card in a new window.

Collapse the title section.

Another item contained in the top section of the metadata is the Comment Bubble:

In this you can leave comments regarding an item.

Each comment will be registered, however, it is not recommended that you use this for internal communication, as comments do not trigger any notifications, so they are easy to miss. It is also important to note that after the item is approved, comments get locked, so you will not be able to add more.

If you need to add any comments regarding the file, you can do so by clicking on the blue speech bubble. This will open the Comments interface.

Write your comment and click on save.

With each Major version update the system will add an automatic comment, so you can easily track which version comments were tied to.

Section 10: Preview

If there is no need to modify a document, you can click on the Preview tab in the Right Pane. In this mode, you can easily browse the document content.

Most common file formats are supported by the preview function e.g., all MS Office and Picture/Video formats.

NOTE: The preview pane will not show the header and the footer of the document, unless you are looking at an already released version in PDF.

Section 11: Visual Workflows

The visual workflows provide users with a graphical representation of workflows in SimplerQMS, enhancing accessibility and comprehension of processes. With the Visual Workflow feature enabled, you can easily identify the next and previous steps within your workflow. This visual representation acts as a roadmap, simplifying decision-making and allowing you to anticipate required actions. All users have access to workflows within SimplerQMS.

To access workflows for documents and objects:

I. Launch SimplerQMS on the Windows Client.

a. Please note that this feature is currently available exclusively on the Windows Client version.

II. Click on the document or object you wish to view the workflow for

III. Click on the Workflow Tab in the Right Pane

IV. Within the workflow section, you will now have the option to view your workflow in a graphical format. For detailed information click on the cards to expand the step descriptions:

V. In addition to the visual representation, you can access more information by utilizing links to the knowledge base.

a. If you require detailed context or information about a specific step or aspect of your workflow, simply click on the relevant link to access the knowledge base.

Section 12: Quick Search

Quick Search is a useful way to look for items in the vault. It looks for objects that contain the search word in the file contents or metadata.

In the search field, enter a search string that has to do with the object, such as the title, the person who has edited it, or a process it’s related to, and click the search button.

Adding of words to the quick search functions like “And” meaning that searching is filtered based on all applied words.

Search is most successful when you use the unique ID that the system assigns to items (the numbers) if you are looking to find something specific. The search can be enhanced by using the filter options. These open automatically when the search bar is clicked.

View

  • Lock in the view you are currently accessing to only search for items within the view currently opened.

Search In

  • You can choose whether to search within the metadata, file contents, or both by selecting the Metadata, File contents or both in the Filters tab. By default, both metadata and file contents are searched.

Object Type

  • The list includes all object types, and you can filter for each separately, or multiple together. When the search functionality is used, the listings area shows all the relevant items in groups based on object types.

Last modified

  • Filter based on the time when the item was last modified.

Archive

  • The list includes all currently existing archives that are tagged on your documentation.

Document Type

  • Filter by relevant document types to narrow down your search.

Project List

  • Search within projects related to your documentation

Is Current

  • Exclude or include documents that are retired or not current. True selection results in only active copies begin shown, while false results in objects and documents that are retired or archived.

Selected filters are retained for all subsequent searches until you close the window or log out. Toggle them as default by clicking on the padlock that appears next to them when you hover over.

Clicking on the reset button will erase all selected default filters.

You can further narrow down your search for specific terms by placing your search query in quotation marks.

Smart Search features do not support special characters aside from those for currencies. This means that separating your search with /, &, + or other special characters will be recognized as a space between words and the character itself will not be indexed.

Section 13: Task Area

The Task Area is located on the left side of the user interface and contains frequently used commands and shortcuts divided into separate sections. Each section can be expanded and collapsed by clicking the arrow on the grey vertical tab. When no object is clicked, the only sections visible are Create and Go To. All other sections are only relevant for object specific operations.

1. Under the Create section, you can find the same objects that you can find in the create tab or under the Create button.

2. Under the View and Modify section, you can select object-specific operations, such as Check Out and Check In, Object Properties, and History (audit trail).

3. Actions contains shortcuts related to an object. In the example you can see document specific actions. By clicking any of these buttons, relations between the document and the item created will be established and in many cases the item class will also be defaulted.

4. State Transition is the most important section for any object. Using these buttons will allow you to move an object through its workflow. These also change depending on the current state of the object and the role that a person has assigned to them. Each of our work instructions for specific object types point out the most important state transitions options for each state.

5. Go To contains the views from the 2. Main Views, which are the core views for navigating. Single-clicking any of these will take you to the corresponding view.

a. Add your own sub-view shortcuts by right click on a relevant view and clicking on “Add Shortcut to Task Area”.

b. Rename, remove or organize these by right clicking on them. You can also reset to default.

a.
b.

Section 14: Transferring external documents and files to M-Files

Most documents are created from templates in the eQMS but external documents e.g., created by other stakeholders can also be added directly to the system. They can be filed under all document classes. If you are adding files that do not need to be controlled by you and just need to be filed, use the Document Attachment class. Read more about this feature in the WI: Attachment

Follow one of the ways described below to transfer document(s) and files to M-Files. After transferring a file to M-Files, fill in Metadata Card and click Save. Your file has now been saved in M-Files.

I. Add a file from Microsoft Office Programs

a. Click the M-Files Tab in Word, Excel or PowerPoint and the click Save to M-Files

II. Add files from Microsoft Windows by Right Click.

a. Select one or more files, right-click and select Add to M-Files

III. Add by copy paste.

a. Copy the file you wish to add

b. Click on Checked out To Me and paste

Section 15: Exporting metadata and documents from M-Files

Metadata and files/documents can be exported from M-Files in the following way:

I. Search for documents, which should be included in the export

a. Go to File (click the ALT button) and choose Export

II. Export all documents, which are displayed in a view

a. Right click on the view which contains the files you want to export

The following window appears:

III. Click OK to complete the export.

IV. The metadata now be available as a CSV file with references to all the documents which are exported to one or more folders.

Section 16: Convert to Searchable PDF (OCR)

M-Files can convert images imported from external file sources into searchable PDFs using optical character recognition (OCR). This makes full-text search of scanned documents possible. After conversion, you can find the PDF document by searching the actual document content.

Optical character recognition can be performed on the following file formats:

PDF, TIF, TIFF, JPG, JPEG, BMP, PNG.

To convert one or more files to a searchable PDF, select the file/s, right-click on the file/s, click Scanning and Text Recognition (OCR) and Convert to Searchable PDF.

Then click Convert to complete the conversion.

Note, that the content from the PDF document will first appear in search results after the M-Files Server has updated its file index. This takes place every night.

Section 17: Creating Hyperlinks

To create hyperlinks to documents, right-clicking on the document you want to link to and click Share> Get Hyperlink.

NOTE: Most relevant document to link to are the working copy and NOT the released version.

Clicking the Advanced button will allow you to create hyperlinks to either the latest version or the current version of the document.

Section 18: Version History

One of the many advantages of M-Files is the fact that the earlier versions of objects are retained. You can go back in the object history and see any change in metadata and/or files.

The moment you create a document, it captures the first version of the document and saves it on the server. When you make additional actions to the document, it captures changes as a new file version.

For any version, the metadata card and file can be displayed for how it looked at that moment. The system creates a “Version” for any metadata card change both done by users and server. New file versions are created whenever the user checks in a document. Major versions are created when drafting the first version or when a released document is forwarded for updating creating a new major version.

To view the version history for a document, right-click on the document and click History.

Section 19: Creating a View

In M-Files, documents and other objects can be categorized into different views according to their metadata. Creating views is largely based on specifying the metadata used for searching and categorizing documents.

Create a new personal view by clicking Create and the click View

There are two phases in determining a view:

I. Specify a filter to ensure that the view only displays objects you want to see. Specifying filters is similar to defining search criteria.

II. Determine the folder structure of the objects. This is useful when you have a large number of objects, and you want to group them into different levels according to specific properties.

In the example shown, the documents must be checked out to the user Andy Nash, they must not have been deleted, and they must be of the type Drawing. No properties have been added to the display hierarchy in this window, so all documents that meet the criteria are displayed in a single list.

Section 20: Microsoft Office Functions Overview

All M-Files/SimplerQMS functions are available through the M-Files toolbar.

The functions presented below are available in Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook versions 2007, 2010, 2013, 2016 and Office 365.

You can open a document for reading or editing directly from the document vault. This function is also available on the File and Office menus.

This allows you to easily search for documents or browse through views.

Save is the handiest way to save a new or edited document to M-Files. When you save to M-Files directly, the metadata card opens for editing just as it does when you create a new document via M-Files Desktop. This function is also available on the File in the office menu 

Explore M-Files is used to show the current document directly in the M-Files user interface (if the opened file is in M-Files). This makes it is easier to perform functions such as copying or sending a link to the file by e-mail.

Section 21: Check Out

Checking out a document means it is being opened to an editable or readable application, such as MS applications. When an object is checked out by a user, others cannot edit the same document. It is also important to note that if you have the document checked out on a computer, it is tied to that computer access only. If you try to open the same checked out document on your other computer, it will be locked for editing and tied to the local cache of the other computer. We recommend that at the end of each workday you check you documents in, to avoid losing data saved only locally.

NOTE: When a document is checked out to you, you are the only one with access to modify the document, others can only view the document in read-only mode. You will know that a document is checked out to you if you see a green tick next to the document icon.

Other users will see a red stop sign instead of the checkmark as well as who the person who has the document currently checked out if the document is unavailable for editing. Find this by clicking on the document and the upper right side of the metadata card will show the details.

Section 22: Check in, and Check in Changes

Once you are finished editing a document, use the Check In function to check in and save the document to the document vault. If you select Check In Changes, it will allow to save the changes and still be able to keep editing.

Another way of doing a Check In of a document, is to simply close the document and click “Yes” for saving. Then you are asked if you wish to check the document in or the system will check in the document automatically, id the setting is enabled in your M-Files Desktop Settings. Refer to our WI: Installing SimplerQMS M-Files on Windows and Adding Vaults

Section 23: Undo Check Out

The Undo Checkout function keeps the latest saved document and cancels any changes done by the user. If the Undo Checkout function is performed on a document that has been edited, all changes made after the document was checked out will be lost.

Note: Undo Checkout cannot be used on a single file of a multi-file document. In this case, the function is not available in the M-Files menu.

Section 24: Compare

With the Compare function, the content of the current document can be compared to an earlier version of the same document. Compare is only available in Microsoft Word.

I. Open the word document for which you want to compare changes between different versions.

II. Open the M-files tab and click the Compare button

III. Select the document version you want to compare with the document you have opened. Click OK.

IV. The four sections Revisions, Compared Document, Original Document and Revised Document will now be visible.

Section 25: Insert Property

Document metadata stored in M-Files can be included in document contents by using the Insert Property function.

You can set up text fields or cells in Microsoft Word, Microsoft Excel, and Microsoft PowerPoint documents in which the selected M-Files properties are filled in automatically. For example, you can select a customer name and address from the document properties and insert them as the recipient’s contact information in a proposal.

Refer to our WI: Managing Templates for detailed information.

Section 26: Properties

The Properties function allows you to view document properties defined in M-Files. When you click the Properties button, the metadata card that is opened is the same as the metadata card in M-Files.

Section 27: Working with Outlook

You can save e-mails with or without attachment files simply by dragging messages to your M-Files folder in Outlook or you can save the e-mails with or without attachments.

After saving the e-mail to M-Files, the New Document box is open, and you must choose a Class for the e-mail.

Now follow the instruction for Working with Controlled Documents

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Installing SimplerQMS M-Files on Windows and Adding Training Vault https://www.simplerqms.com/knowledge-base/installing-m-files-on-windows-adding-connection-to-test-environment/ Wed, 23 Feb 2022 09:19:07 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=243298 Purpose Installing M-Files on a PC. Step 1 – Download the M-Files Installation Package                  Go through the following steps to install M-Files: Open a web browser and go to www.simplerqms.com/m-files. You will be redirected to our file share on SharePoint.  Download the installation file and run it: Step 2 – Install the M-Files Online […]

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Purpose

Installing M-Files on a PC.

Outcomes and Prerequisites

Outcomes

M-Files has been installed on a PC.

Prerequisites

The PC must comply with the system requirements, see https://www.m-files.com/user-guide/latest/eng/operating_system_requirements.html

Step 1 – Download the M-Files Installation Package                 

Go through the following steps to install M-Files:

Open a web browser and go to www.simplerqms.com/m-files. You will be redirected to our file share on SharePoint. 

Download the installation file and run it:

Step 2 – Install the M-Files Online Application              

The M-Files Installation Wizard will appear:

  1. Click “Next”. The End-User License Agreement will now appear.
  2. Select “I accept the license agreement” and click “Next”
    • Depending on your Windows version and setup, the following dialogue box might appear: “Do you want to allow this app to make changes to your device?” Click Yes. M-Files will now start installing.
  3. You will then see: “M-Files has been successfully installed.”
  4. Leave the check box checked “Start M-Files Desktop configuration.”
  5. Click Finish.

Step 3 – Adding a New Vault          

You should now see the following box:

Click Add

If you don’t see the M-Files Desktop Settings box as shown above, then right-click on the M-icon in the Windows Hidden Icons Tray at the bottom right of your screen. Then click Settings > M-Files Desktop Settings.

Step 4 – Setting up the SimplerQMS Training Vault

This vault is used for training in the different SimplerQMS modules. This is a shared vault across all customers, so make sure that you do not upload anything confidential once you gain access.

  1. Into the window that opens after clicking on “Add”, input the following information:
    • Name: SimplerQMS Training
    • Server Name:  simplerqmstest2.cloudvault.m-files.com
    • Port Number: 443
    • Protocol: gRPC
  2. Test the Connection by clicking on “Test Connection”
    • this should say it succeeded to confirm that all the details above are correct
  3. Set the Authentication to: Specific Windows User
  4. Remove the Check mark in “Log in automatically when Windows is started”

5. Click on the empty drop-down next to “Vault on Server”. A Microsoft Log-in window will open:

6. If you previously used another Microsoft account, then click “Use another account”

7. Log in using the credentials you receive from our team members

  • Look out for the following:
    • The email address should end in “@simplerqmstest2.com”
    • Your password will need to be set after entering the temporary password you have received from us

8. After log-in the “Vault on the server” will display ‘SimplerQMS Test 2’. Select this option

9. Click OK to save the Vault Connection

10. Click Close to close the Vault Connections box

Step 5 – Start M-Files Online

Start the M-Files application by clicking on the M-Files desktop icon. 

Select the vault you wish to log into.

Enter the username and password again. (if prompted)

Wait for this dialogue box to appear (this can take up to 20 sec.):

Click Allow. The M-Files Applications has now been installed and will now open.

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Getting Started with SimplerQMS M-Files in Chrome Web Browser https://www.simplerqms.com/knowledge-base/getting-started-with-simplerqms-m-files-in-chrome-web-browser/ Tue, 22 Feb 2022 12:51:09 +0000 https://www.simplerqms.com/?post_type=ht_kb&p=243282 Purpose Tutorial for the first use of SimplerQMS in the Chrome Web Browser. Step 1 Open your Chrome Web Browser. If you do not have Chrome, please install it first. For Training: Go to this address: https://simplerqmstest2.cloudvault.m-files.com/ For your own production: Go to this address: https://[insert company name here].cloudvault.m-files.com Step 2 Create a Bookmark for […]

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Purpose

Tutorial for the first use of SimplerQMS in the Chrome Web Browser.

Outcomes and Prerequisites

Outcomes

You are able to login and use SimplerQMS

Prerequisites

Chrome for Windows or MacOS installed

Step 1

Open your Chrome Web Browser. If you do not have Chrome, please install it first.

For Training:

Go to this address: https://simplerqmstest2.cloudvault.m-files.com/

For your own production:

Go to this address: https://[insert company name here].cloudvault.m-files.com

Step 2

Create a Bookmark for this tab named SimplerQMS.

Step 3

Click the link Log in with Azure AD

Step 4

Type your personal company email address and click Next. Then type your password and click Sign In.

If this is the first time you use your email address to login, then you will be prompted to change your password.

Step 5

You should now see the web site, which looks like this:

First time you login, you need to install the M-Files for Chrome extension. Do this by clicking the this extension link in the top bar.

Now, add the extension to Chrome.

Check that extension has been added by clicking on the Extensions icon at the upper right corner of your browser

Complete the installation by clicking on on here. In Windows, the installation file will appear at the bottom of the screen. Run the installation file.

On MacOS the installation ZIP-file needs to be downloaded and then run it.

When the installation is completed, close your entire Chrome Browser (not just your tab).

Step 6

Make sure that Notifications for the Google Chrome Browser are turned on.

On Windows:

Search for “notifications” in the Windows Search bar and click Notifications & Action Settings:

Scroll down to Google Chrome and switch the notifications on if they are turned off. (You can switch them back off again after completing this guide).

On MacOS:

Go to System Preferences > Notifications

Make sure your Google Chrome Notifications are turned on (You can switch them back off again after completing this guide).

Step 7

Open Chrome and click the SimplerQMS bookmark you created earlier.

On Windows:

You should now see a notification which asks you to Allow Access. Click Allow.

On MacOS:

You should now see a notification on the right side of your screen, Click Allow.

When this has been successfully completed, then you should no longer see the yellow bar in your browser:

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