SimplerQMS eliminates your dependency on paper archives and allows your medical device company to operate on solid electronic processes, records and digtal signatures.
ISO 13485 Certified
SimplerQMS is certified according to ISO 13485:2016. This is the gold standard in the medical device industry, which guarantees a high quality of our products and services.
Download our ISO 13485:2016 Certificate
Furthermore, SimplerQMS is compliant with the document control requirements stated in FDA 21 CFR Part 820.
FDA 21 CFR Part 11 Compliant
SimplerQMS supports the administration of electronic records and signatures in compliance with FDA 21 CFR Part 11. This involves maintenance of the detailed audit trail of actions performed on the documents, secure monitoring of individual actions, and certification of electronic signatures with usernames.
SimplerQMS follows the guidelines of GAMP5, which is a Risk-Based Approach to Compliant GxP Computerized Systems.
Eudralex Annex 11 Compliant
SimplerQMS is compliant with Eudralex Annex 11, which is a checklist that enables the European regulatory agencies to establish the requirements for computerised systems that relate to pharmaceutical products and medical devices.
Data Center Certifications
Our qualified data center, which runs on Microsoft Azure is certified to:
- ISO 9001:2015
- ISO 27001:2013
- ISO 27018:2014
Validation can be a very time-consuming task when implementing and maintaining software in a regulated environment. SimplerQMS includes all validation activities, which therefore require minimal involvement from your organization.
SimplerQMS and our Data Center provider are ready for regulatory audits and inspections.