CASE STUDY

Endospan Expands Quality Process Coverage with Dot Compliance


THE CHALLENGE

Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease, was using Dot Compliance for Document Control, and wanted to  expand additional processes. The company was manually handling change  control – signing, printing, and scanning change control forms; DHR forms,  QC inspection forms, purchase orders, etc.). 

Due to COVID-19, with so many employees working remotely, the company faced additional challenges. The forms needed to be checked and approved via email. There were problems with having them signed by all parties and making sure that they were printed and scanned of good quality.

THE SOLUTION

Endospan expanded the use of Dot Compliance ready to use QMS solutions with Change Control module, templates for electronic forms, and training management to streamline training effectiveness.

NEXT STEPS

Endospan plans on deploying additional Dot Compliance modules in 2021: Quality Event management, CAPA management, Deviation management, Complaint management, Audit management, Supplier management,  Maintenance and Equipment management, Binders (for DHF & Technical File), Controlled copies, etc.


Dot Compliance has proven to be invaluable this year and a great asset to the company…We were recently audited by DEKRA with very good results. It was mentioned in the summary meeting how we were able make improvements to our  QMS due to the many options available in Dot Compliance system and how we could not have achieved all our goals  within the desired timeframe if we did not have Dot Compliance.

Sharon Katherine Haviv, Quality Records Manager

ABOUT

Employees

41

Industry

Medical Device

Location

Israel