21 CFR Part 11 Compliant Software

It may not exist. This is from a Web site called 21CFR Part11.com

"It is not possible for any vendor to offer a turnkey 'Part 11 compliant system'. Any vendor who makes such a claim is incorrect. Part 11 requires both procedural controls (i.e. notification, training, SOPs, administration) and administrative controls to be put in place by the user in addition to the technical controls that the vendor can offer. At best, the vendor can offer an application containing the required technical requirements of a compliant system."

http://cgproducts.johnsoncontrols.com/MET_PDF/1201111.PDF

Thanks, I needed that!

Why don't you want to use Bluemountain?

We're actually comparing what's available.

here at Glaxosmithkline at dartford kent..

we are unsing the honeywell documint RX software to shcedule and recoard all the data for instrument calibrations, electricl circuit checks, earth proving units, emergency light inspections. It retains all the history of the chalibratins / inspections etc.. all 21 CFR 11 compliant and has been audited by the FDA on serveral occations.. reporting is good and all validated with electronic signiuters. Requiers Engineering, User, tech deleopement and quality to approve all quality and safty set up and changes to the system. Well worth a look at.

I will look into it. Thanks