Tired of Manual Paper Documentation?
Get eSignatures and Automated Workflows in a Ready-to-Use Validated eQMS for Life Science.
FDA 21 CFR Part 11
FDA 21 CFR Part 820
✓ ISO 13485:2016 Certified
✓ EU MDR Ready
✓ Efficient Document & Design Control
✓ GxP Compliant & Validated
✓ Efficient Training Management
✓ Easy Deviation & CAPA Tracking
What We Offer
Reduce your risk by working with our Life Science Specialists, with more than 30 years of experience implementing validated software. We ensure that your eQMS is audit-ready at any time.
21 CFR Part 11 Compliant eSignatures
SimplerQMS enables you to sign any record with our Part 11 Compliant eSignatures. Automated workflows and notifications allows for a seamless and fully digitized process – supporting both internal and external users.
How Did Reapplix Move From Paper in 1 Month?
Reapplix is a regenerative medicine company that helps people who suffer from hard to heal diabetic foot ulcers, which may result in amputation. The company is in the initial commercialization phase in the US and selected European markets and was looking for a way to get rid of inefficient paper-based documentation and processes.
What People Are Saying
The collaboration with SimplerQMS has lived up to our expectations. Their service has been superb and very supportive.
During the implementation of SimplerQMS, the expectations of SimplerQMS’s team have been exceeded. We have got a lot of help – also at awkward hours of the day.