Re: compliance with 21 cfr part 11

I have built big nationwide health databases, and other secure systems
requiring traceback and auditability.

The more you are able to make the required processes transparent to the
end user, the happier they are and the fewer problems you have from a
user acceptance perspective.

Audit does belong in the database, go and look at where the likes of
Sybase ASE and DB2 do it. If you do it up front, you are continually
maintaining it.

Few systems control appropriate access to data; that is a harder and
proprietary trick.

Robin St.Clair

On 05/12/2013 00:07, Rob Sargent wrote:
> On 12/04/2013 04:41 PM, John R Pierce wrote:
>> On 12/4/2013 3:34 PM, e-letter wrote:
>>> Can postgresql be deployed with audit trail and data validation
>>> capability, to meet compliance with 21 cfr part 11?
>>
>> IMHO, that sort of audit trail should be higher level in your
>> business logic, not in the database. but that's just my opinion,
>> worth exactly what you paid for it.
>>
>>
>>
> I've been through 21 cfr part 11 (successfully) and it has nothing to
> do with the database vendor and everything to do with how you track
> changes to the data.