SMB Validation

What must a vendor do to claim that their hardware and software are 'compliant' with 21 CFR Part 11?

No vendor can claim that his or her software products are certified Part 11 compliant. A vendor, instead, can say that he has all of the Technical Controls for 21 CFR Part 11 compliance built in to his product. Remember, it is the responsibility of the user to implement the Procedural and Administrative (and correctly and consistently) Controls along with using products with the correct Technical Controls for overall Part 11 compliance.