Re: compliance with 21 cfr part 11

Robin <robinstc@xxxxxxxxxx> · Thu, 5 Dec 2013 04:15:30 +0000



    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.