>Hi Al,
>
>21 CFR 11 provides the regulations for the submission of certain required documents in electronic rather than paper form, and permits the use of electronic signatures rather than handwritten signatures to authenticate electronic documents.
>
>Exactly what is your questions.

In the clinical trials business, to the best of my knowledge there are only 2 software programs "certified" to comply: ClinTrial and Oracle Clinical. These are expensive - licenses alone start at the $250K ballpark.

It seems the FDA specifically tried to lay out principles it wants followed, rather than specific technologies or implementations. I was wondering if anyone has used either of the above-mentioned programs, or any other "compliant" applications in any other FDA-related industry and could comment on:

- how well these programs actually comply with the "principles" of the regulations;
- which portions are of most real-world interest to the FDA;
- if any de-facto technology standards have arisen in response to these regulations;
- any idea on the steps involved in seeking certification