The Interactive Quality Manual Creator Tool helps you to create your own Quality Manual, fully integrated with QMS processes or workflows, in accordance with ISO 13485 and FDA QSR (21 CFR 820). It has a modifiable structure where all chapters are editable, and immediately can connect all related processes. This is very handy for maintaining a transparent QMS, and very important for having a successful audit.
The GAP Report Tool reveals and tracks ‘’holes’’ between what you currently do and what regulatory compliance is expecting. It helps you to follow your progress in QMS implementation – it shows what processes are you using and which ones you are not – based on what is appropriate for your product’s characteristics, the structure, and size of your company and your main activities.
The Quality Manual Creator and GAP Report are available to QMS Managers.
On the left sidebar, choose “Quality Systems Manual and GAP Report”.
When you click on Quality System Manual and Gap Report Module, you will get these 2 options:
Quality System Manual and GAP Report.
If you want to choose GAP Report, you will get a message: "You need to finish Quality Systems Manual in order to start GAP Report".