Q: Do study site personnel need to be able to answer questions about sponsor-provided computer systems during an inspection?
A: Yes, and there’s a simple thing that sponsors and CROs can do to prepare their sites.
This excerpt was lifted from an online, interactive course entitled “Developing a Part 11 Compliance Plan in Clinical Research.” While the course mainly targeted sponsors and CROs, who have the heaviest regulatory burden in this area, sites also have Part 11 and validation concerns, as demonstrated by this question.
Presenter Lisa Olson, a CSV/Part 11 expert with Polaris Compliance Consultants, briefly described her recommendation, which is both simple and effective. (And since that is total catnip to a compliance blogger, I interviewed her after her presentation to develop the following piece.)
So here it is. Here’s what she said...
