e-QUALi
A paperless solution
Since 2017, the FDA and the EMA decided to join their requirements between the FDA 21 CFR Part 11 and the EMA Annex 11. We are compliant.
Asklesoft created e-QUALi following the guidance of the FDA 21 CFR Part 11. Combining technicians feedback with experience developpers, we spent years creating the easiest digital solution for the commissioning in the pharma industry.
Prepare
Manage your URS and its different version within one space. Make sure everyone is working on the latest. Automatically. No more paper files to move on with your equipement.
execute
Drive your FAT, SAT, QI and QO with all the stakeholders in real time. Edit, create, sign, validate every test in one place without printing.
analyse
The fast expansion of technology these last decades revolutionize our way of managing datas. Keep tracks of them, improve yours processes and be audit ready.
Ease your life, digitalize your Q&V
Fill your tests on your computer.
e-QUALi makes you able to edit your tests directly on PC, tablets and phone. Our cloud based solution does notrequired installations and can be accessible from any devices with your 2 FA authentification.
AUDIT TRAIL
The FDA 21 CFR insists on this point : every action must be recorded and timestamped.
E-QUALi records every one of them and automatically timestamps, saving you lots of time.
PDF EDITOR
We implement a PDF editor. Therefore, you can directly input your existing files and edit them on the platform.
Writing, highlighting, underligning,.. Work like you are used to but on a digital tool.
Bonus ? Every action is automatically recorded in the audit trail.
Deviations
E-Quali also manages deviations.
They can be linked or not to one or several tests.
According to YOUR way of working.
Why e-QUALi?
Electronic signature
Directly e-sign your tests and documents on e-QUALi FDA compliant..
version Management
Be sure to work on the latest approved version and everyone does the same.
DATA INTEGRITY
Asklesoft saves and protects your datas according to the FDA regulations. Your data will be audit ready anytime for at least 10 years. You are the owner and can store them somewhere else too.
Real time dashboard
Our cloud based solution is updated in real time and allows all the project’s stakeholders to follow the projecs. In real time. Without reporting.
ASYNCHRONOUS work
Real time sync without overwriting enables people to work in different times. Or different jetlags. We ease your overseas qualifications and validations.
friendly user experience
e-QUALi is edited by and for field workers. Our UX has been designed to avoid unecessary training. It is easy to handle because that us already the way you work.