The evo820 Quality Management System (QMS) enables Laboratories to take the necessary steps to becoming FDA 21 CFR Part 820 compliant by adhering to FDA regulations. You receive a cloud based Quality Management System utilizing our custom designed application that include SOPs, logs, forms and work instructions customized to your laboratory. You can access it anywhere, which dramatically improves your laboratories ability to comply with the FDA. Download, print and view with just the click of a button. Incredible Value – At a price of what you would expect off the shelf, but customized to your specific needs and requirements.
- On demand, online support and assistance with implementation of the Quality Manual. Access to online training videos for your staﬀ.
- Event notations for upcoming required meetings. Emails that inform you of specific required meetings that you will need to hold.
- We provide templates to assist with the meeting discussion and the forms required to be completed and added to your Quality Manual. There are several required meetings each year and the FDA looks for these meeting notes during audits.
- Cloud storage and backup of your Quality Manual (QM) and related documents.
- Constant monitoring or your Quality Manual to assure you are properly maintaining the documents. evo820 staﬀ will be notified when you download a form or document and save it to your cloud stored document.
- We will review your documents to assure they are properly completed. If there is no activity on your account, we will be notified that there needs to be attention to your account and we will review your QM and inform you of any non-compliance within your QM.