I’m a CSV Validation specialist. I’ve worked in the pharma industry for about 17 years now in all areas of validation and QA. I’ve always contracted in a consulting capacity but I am currently in my first staff position.
I am working for a medical device company who are a big global company in lot’s of different industries, they are fairly new to medical devices.
They are mainly contract manufacturers of Class 3 implants, hip joints, knees, vertibrae etc.
They say they plan to move into end-to-end products and obtaining their own FDA licence.
They sold the position to me as requiring regulatory advice and requirements. I have put in place lots of procedures they were missing and slowly starting to implement validation and good documentation into their ways of working but they are really beginners in terms of regulatory expectations.
I was not directly involved but was aware that they were in the process of implimenting a new ERP system (ERP LX). Having been involved in a few ERP validation projects myself I was quite interested with how they were going about it.
My problem is this, I repeatedly told the Quality Manager to be careful with the validation as it is lengthy and detailed to get right requiring plenty of resource with some good CSV experts. I was always assured it was under control.
I heard they were going live with it and decided to have a closer look. I was shocked at the fact no lifecycle quality controlled documentation had been created. No URS which obviously means no detailed FS, there is no correct risk/impact assessment and no traceability matrix, and no OQ testing!
From what I can see there is just the old fashioned IT type testing which is very minor in detail and documentation.
I decided to call a meeting with key people, Site Director, Quality Manager and IT manager to try and assess what they have/haven’t done. I then walked through how it should be done. They could not comprehend the effort I was suggesting, yet my entire approach was was completely backed up with GAMP and FDA requirements. They took it on board but say they cannot have the resource required and they seem to want to try and created various documents after the event just to say they have them! They are missing the point of what we do and why completely.
But I feel like one voice not getting heard.
So my question is how best to convince them what they have to do? I do not want to be involved in a company that are determined to learn the hard way.
I’m sorry for the very long post but I wanted to try and get the background as clear as I can.
Please ask anything you need for more info on this situation and all suggestions are more than welcome.
Thanks for your time, my kind of people