Reapplix recently went through their first ISO13485/MDD audit after digitizing their QMS.
“The notified-body auditor was especially interested in our eQMS validation documentation, which is a requirement in ISO13485:2016. SimplerQMS had helped us with the validation and provided critical documents like the risk analysis, regulatory criticality assessment, validation plan, OQ & PQ, validation report and certificate. The auditor was very impressed with this work. We were able to find and show procedures, instructions, reports, meeting minutes etc. very fast by searching in the system” says Ulla Tedaldi, QA Manager at Reapplix.
“The collaboration with SimplerQMS has lived up to our expectations. Their service has been superb and very supportive”
Many startup’s fear that going from a paper-based QMS to an electronic eQMS is an unfeasible task. Therefore, SimplerQMS has set of tools that will help move the historic documentation. To save time for the customer, SimplerQMS also comes with ready-to-use procedures for Document Control, Identity Management, Electronic Signature Agreement etc.
“I can seem scary before you start and of course there is some work getting from paper to and electronic system. However, when you start to see the benefits, you realize that it was the right decision. So just go for it!” says Ulla Tedaldi, QA Manager at Reapplix.