Documenting Testing. 190

  • Hello. 😢 I feel everyones pain… 😢
    I am a lowley Network Administrator and Acting Oracle DBA for my public company. (Pharmaceuticals Industry) We are a FDA regulated company, and for the better half of 2 years I have been dodging the bullet. (VALIDATION…)
    My question is, I am currently finalising systems interfaces for our Oracle Production server, and my auditors are asking for several things. They require test scripts and technical creation scopes of work… no problem I have developed those already. The thing that really stumps me, is that they are asking to document my testing of the interfaces. I am somewhat famillar with FDA and cGMP practices, and to me this seems like an IQOQPQ under protocol. Anyone tackled this yet? I am not asking for copies of docuementation, but just some sort of overview to satisfy this requirement. (Sample’s would work too.)

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  • Hey buddy,
    First of all you are NOT a just and administrator…you have more power than you realise.
    To answer your question, I recommend you ask your self…
    ‘how do I know that the interfaces work correctly?’
    ‘have I addressed all the audit risks ie. completeness, accuracy, validity and restricted access’
    So getting back to your interface, how do u ensure the data from one system is transfered correctly over to the other?, who has access to the interface? is there a schedule for it to run automatically? or is it manual?
    what validation eg. control totals or any system controls to ensrue the data is valid?
    once you answer these questions they should be able to formulate a testing plan for you. Perhaps it could be as easy as do a one to one check for the first year of SOX from your data mapping then in subsequent years make sure the changes to the interface are well evidenced.
    good luck

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