I want to know wether baan is FDA compliant . If not how to make it FDA part 21 compliant.

regards,

George

The users in the following thread were looking for the same thing:
http://www.baanboard.com/baanboard/showthread.php?t=24665

sadly they did not post the answer, you might want to connect them personally (Via PM/Email) and ask them.

- George

We also interested on this, please do post update to this thread if you have any finding.

My co-worker martin can give you the following information:

Hello all,

first of all you have to know which part(s) you have to be "compliant" with:

CFR (Code of Federal regulations) title 21 contains the whole food and drug act. It has many different parts, as for example part 820 - quality systems regulation, or part 11 - electronic records/electronic signatures...

The "out-of-the-box-system" (baan) itself can not be compliant like you may need compliance in your company (also if it is perhaps sold like that - I don't know).

You always have to look at your processes which should be computerized with baan, which regulative requirement, norms and guidelines applies to it, and then normally you have to validate the system as a whole.

If you are in the pharmaceutical or medical industry, you should know how to proceed ...

In our company we have validated the ERP Ln system according to the specific european and american (fda) guidelines - therefor we can say we are compliant with the above mentioned, and for our company applicable parts...

regards,

Martin