An easy-to-use Online Quality Management System (QMS)
What makes Wismatix QMS different from many other systems?
Our Online Quality Management System comes completely out-of-the-box with all modules needed; there is no need to choose which modules you want based on your budget! All you need to do is choose a company license based on how many employees you are in your company. We have put together some very competitive prices for your new Wismatix QMS license, and remember; with Wismatix QMS, you get a system that will grow with your company.
Wismatix QMS will help you gain complete control over your Quality Management by implementing a system that all your employees will use. The result – optimizing your company performance and boosting your bottom line.
Wismatix QMS supports
Want to check it out to see if it’s right for your company? We invite you to sign up for a free demo account! Review the modules, see example data, experience the ease of use in entering information, and our Sales Managers will answer any questions you may have.
Does this QMS include all I need to run my Quality Management System?
Wismatix QMS is a fully featured online Quality Management System that comes with all you need straight out of the box!
We don’t believe that your Quality Management System should be pieced together based on the cost of modules – With Wismatix QMS, you’ll receive all the modules listed below for a full-featured Quality Management experience.
FDA and ISO links
FDA (Food and Drug Administration) – eCFR (Electronic Code of Federal Regulations)
- CFR Title 21 Part 11 – ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
- CFR Title 21 Part 820 – QUALITY SYSTEM REGULATION
ISO (International Organization for Standardization)
- ISO 9000 family – Quality management
- ISO 13485:2016 / Medical devices – Quality management systems – Requirements for regulatory purposes
(FREE in a read-only version directly from ISO due to COVID-19)
- ISO 14971:2019 / Medical devices — Application of risk management to medical devices
- ISO / IEC 62304:2006 / Medical device software — Software life cycle processes