Good morning,
I am looking for who is responsible for writing the validation of a new process (includes RFID and computer system)? We are a medical device company under the FDA and I am use to people providing necessary input and RA/QA writing the validation. Please provide any thoughts.
Thank you!
Hi ZaMoon
I agree with Yodon and Optimist. Yet collaboration can be a hard thing to bring into a culture, but a collaborative approach to validation is necessary to having a solid validation process and report. I think of it like having the foundations of a structure capable to support weight.
Obviously you asked this a few months ago so this maybe a bit late, but the fact that your asking indicates your organisation doesn't have a clear approach on this? If I were in your position, I would advocate treating this like a project involving an external contractor - even if you don't have a third party.
Clearly define the roles and responsibilities, and the requirements for that role (lot's of people here said you need a subject matter expert (SME), but your RFID / computer systems SME will have a different scope of involvement to your SME for other product attributes, does your QA review from a processing perspective or RA/QA only?) and build a kind of project scope to help guide the process.
This approach is best used as a guidance and the scope should be revisited periodically - maybe this is not necessary for your organisation, but it sometimes helps to get all participants agreement at the beginning that this scope isn't a blunt instrument to pressure people with.
In the long term, I would include in your quality manual, or whatever your core quality document is called, a section on how to deal with validations like this, or go all out and work up a Validation Master Plan (not, as I understand it, a strict requirement under 21 CFR 820)
I hope this helps.