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
- 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