When FDA 21 CFR Part 11 compliant?

We are about to buy a calibration software package for our facility. We need that package to be part 11 compliant. A lot of companies say they are “part 11” compliant. But who decides they are? Does the FDA audit also supliers of this kind of software. Does the FDA has a list of supliers they have audited and what the results where? Or has every buyer of this software figure it out themselfs?


Alot of companies say this, but don’t believe them, ensure that you test their product beforehand to make sure they have all the functionality that is required for Part 11 compliance.

Usually the sales guys tell you what you want to hear in order to make the sale and usually these guys don’t understand Part 11 anyway.

You should really audit them beforehand and ask them to fill out a Part 11 assessment.

As far as I know the FDA do not audit such companies this is up to your company.


No software on its own can be compliant with 21 CFR Part 11. Parts of the regulation require managment controls etc to be in place - and that’s your responsibility, not your supplier’s.

Some software can legitimately claim compliance to the technical aspects of the regulation, but none is fully compliant.

I agree with Graham, that you should audit the supplier, and ensure that consideration of any requirement for 21 CFR Part 11 forms part of that audit or assessment.

Once you know where the software does or does not meet your requirements, you can decide what to do. Even if all the technical aspects meet the regulation, you will still need administrative controls (eg to meet 21 CFR 11.10(j))


No vendor can certfy that his software or hard ware are part 11 compliance , infact they can claim or make compitable for part 11 requirement… it all depends on user adminstration to prove his system is part 11 compliance

One way is to perform regulatory assessment, it is basically going through the Part 11 requirement to make sure that the system supports them.
The other simple way would be to ask the vendor to include validation package in the contract and see if they can support the validation activity and produce required validation documentation.


Thanx everyone for the reply.
I was a while offline due to vacation etc.

We have agreed with the suplier to hand over an FDS, IQ, OQ and RTM documents. We put these documents in our controlled documents enviroment and finish the validation ourselfs. I hope we finish the project in jan 2010

Gr Dennis