Making the FDA auditor's life easy...

We have long been devotees of Q-Pulse quality management software from Gael.   We had independently recommended Q-Pulse to so many clients that we installed it in our own offices and eventually took the step of becoming accredited agents to supply and install this first rate software in Medtech and Life Sciences companies.  

So we were particularly pleased to receive feedback from Sydney based manufacturer of orthopaedic implants ASDM about how Q-Pulse had directly contributed to a successful FDA audit outcome.

We installed Q-Pulse Quality Management software at ASDM earlier this year and a couple of weeks ago ASDM had their first FDA audit with their system managed by Q-Pulse.  Dealing with an FDA audit can be challenging for any manufacturer.  You need to be able to present your system processes unambiguously and to have ready access to the records and reporting that demonstrates compliance. 

A well structured and electronically managed system not only makes it easier for the users - it makes life easy for the FDA auditor too - as the information they need is available on tap. That's how it was with ASDM.  Commenting on the successful audit outcome ASDM RA/QA manager Manoja Ranawake said:

the FDA inspector commented what we have achieved over the last 12 months was “commendable, comprehensive and detailed”.  From my point of view, this has been largely due the recent implementation of Q-Pulse.

Of course we suspect that it also had a lot to do with the fine work done by the quality professionals at ASDM in using Q-Pulse to set up a smooth and efficient system - but we are happy to take the compliment.

Q-Pulse is more than just document control - it integrates all of the key Quality System processes - CAPA, training, internal audit, service and calibration scheduling, vendor accreditations, management review.  Access to individual records is a breeze and summary reports on all system processes provide comprehensive management information at the click of a mouse.  The whole system comes with the necessary audit trials, security and validation for FDA Part 11 compliance.

Happy staff and happy auditors.  Would you prefer a system that's so easy to use that it frees up your engineers and staff to get on with their job. , and makes audits a breeze by providing the information they need quickly and easily? Does your current system provide clear and graphical management reporting - in real time?  Contact us and we would be pleased to arrange a demo.

Want to learn more about ASDM's innovative range of orthopaedic devices - go to www.asdm.com.au