S
sniderdi
I am new to this forum, so please be gentle with me . So, I started a new company, I come from Source Materials in the pharma background so audits, and the processes were very clear cut. I work for a company that we build customer refrigeration/freezer units, our biggest clients are plasma centers, so that throws us into the pharma world. We have 3 different plasma companies that we build and validate freezers for. One of our clients have tried telling our manager that they are entitled to see all of our documents in an audit, and I know this is not true but need to be able to back that up in our next audit. I know they are entitled to see our general documents, but we have client specific documents, and they should not be allowed to see their competitor's documents. Can someone please tell me if there is a specific regulatory guideline that backs this up and if there is a document we can have them sign that says they may not see other client documents? Anything would be great.