Regulations and Guidelines

The Validation Center library lets you access the software compliance regulations and guidance documents you need for the US, Europe, and many other countries in one place.

You can download the documents here for free, rather than hunting for them on the often difficult to navigate web sites of regulatory agencies and standards bodies.

“FDA Draft Guidance: Use of Electronic Records and Electronic Signatures in Clinical Investigations under Part 11 – Q&A, 6/17” has been added to your cart. View cart

Showing 1–16 of 133 results