Getting started

Installation

Done by Matrix Requirements. By default there should be 4 projects in a QMS folder in the project menu.

• QMS: contains the processes
• QMS_FILE: will later hold records of using the QMS
• HR_FILE: will later hold records of HR department
• CAPA: will contain records of corrective and preventive actions

Configuration

• Give users access rights
  • Only a person with administrator rights can add users and change their access rights
  • QMS project: assign
    • Read/write: for people that need to create/change different processes, risks, working instructions, etc.
    • Read-only: for people who should see, review/approve processes in matrix
    • QMS Viewer: for people who should only have access to the LiveQMS webpage
  • In admin client select the Labels setting and specify who can do reviews
    

    

• Give Publishing rights
  • This can be done in the admin client
  • Category settings
  • QMS Publishing
• Review and update roles in project
  • Details: admin-client QMS project
  • Fix two drop downs
  • Copy dropdowns to HR_FILE
• Review and update SOP
  • Normally SOPs should be good to start with so this can be adjusted later
  • To change go to admin client and adjust labels
• Update Placeholders
  • Select an Item, e.g. PROC-1
  • Put the mouse into the process description field select and edit the Rich Text Replacements for TheCompany
    

    

Look at the following information to see how to:

• Assign specific access to users :

  In the admin client (server administration), in User Management, the administrator can define to which projects the (group of) users have access. It can be done per project or globally for all projects: (the same can be done for Groups)

  

• Restrict reviewers to Processes or Work instructions:

• Give publishing rights to users:

• Configure the QMS roles within the User Management and User Groups.

Updates + Creation of Processes

• Next you should review (all) processes
  • Do they explain well what you do?
  • Are there any placeholders, like please verify / please specify?
  • Once they are good enough set the review label
• Once you have reviewed all processes of one or more SOPs you can publish them by clicking on the PUB category
• Next you should create a list of processes which are essential for you business type and products
  • Add the processes to in the folder where they fit best
  • Assign them to a SOP
• You need to perform a risk analysis to identify additional risks.
• You might need / want to define work instructions for your staff.
• Once the processes have been written the processes can be reviewed by someone who can apply an electronic signature for approval