NEW 2.0

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 videos to see how to:

• Assign specific access to users (direct link here):

• Restrict reviewers to Processes or Work instructions (direct link here):

• Give publishing rights to users (direct link here):

• Configure the QMS roles within the project (direct link here):

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