Hope to see this Guidance published soon, but in the meantime I'm wondering if anyone has any insight into how it will handle what seems to me a conflict between it and 21 CFR Part 11.
There's some really good stuff on the internet and from what I can see it seems like an indirect system such as basic document control would not need to undergo the rigors of traditional CSV, that CSA will suffice? However, 21 CFR Part 11.10 explictly requires that such a system be "validated". Anybody any perspectives on how this might be handled?
Thanks
There's some really good stuff on the internet and from what I can see it seems like an indirect system such as basic document control would not need to undergo the rigors of traditional CSV, that CSA will suffice? However, 21 CFR Part 11.10 explictly requires that such a system be "validated". Anybody any perspectives on how this might be handled?
Thanks