The regulatory authorities expect to be able to review relevant documentation about the chosen systems used in a clinical trial. But what is relevant, what should the sponsor or their representative (CRO) have on hand and what can be accepted as being held by the system supplier?
The white paper explains how Viedoc addresses inspector expectations with regards to computerised systems used in clinical research. This in order to detail how Viedoc complies with clinical regulations, and how best to help you prepare for inspection.
The Viedoc Inspection Readiness Packet gives you access to all the necessary information you are expected to know about Viedoc, and also gives advice on what additional documents you should have on hand if you should be inspected.
The white paper covers all of this, including EMA, CGP, IWG, FDA and PDMA expectations, available documentation, pitfalls to avoid and more.