Hi folks,
I wonder if someone can give me hints for how an "audit trail report" of an ERP (Electronic Resource Planning) system should look like to fulfill the requirements of FDA Quality System audits of medical device manufacturers? We are a small start-up, have a QMS (13485:2016 certificate), and currently we are setting up an ERP software. We are EU-based, but we are planning to enter the US market sooner or later. Our software has audit trail functionality, but nobody of us has any clue of what we should look for (we are all scientists...). I have read several threads here in the forum and PDFs on the net, but I still feel clueless. So, does anyone of you have some kind of experience, maybe already having FDA guys auditing your company? What should/could I do? I am even not sure if I ask the correct question(s)! I think it is not only about data integrity, right?
Truly yours,
Wolf
I wonder if someone can give me hints for how an "audit trail report" of an ERP (Electronic Resource Planning) system should look like to fulfill the requirements of FDA Quality System audits of medical device manufacturers? We are a small start-up, have a QMS (13485:2016 certificate), and currently we are setting up an ERP software. We are EU-based, but we are planning to enter the US market sooner or later. Our software has audit trail functionality, but nobody of us has any clue of what we should look for (we are all scientists...). I have read several threads here in the forum and PDFs on the net, but I still feel clueless. So, does anyone of you have some kind of experience, maybe already having FDA guys auditing your company? What should/could I do? I am even not sure if I ask the correct question(s)! I think it is not only about data integrity, right?
Truly yours,
Wolf