Empower Dissolution option

Hi ,

Does the Dissolution function /option require in house validation ?

Is it GAMP software or can you use it 'from the box as it were?

Any verification of option (GPC too I guess)before using it ?

Answers

  • Hi

    Current discussions suggest that dissolution function is validated and does not require further assessment ie help in Empower discusses algorithm

  • Well, we ran a protocol provided by Waters and after that a local protocol running a PQ according to our SOP.
  • Thanks Degipciaco

    Do you have a copy of Waters protocol you used ?

  • Your testing level should match the risk assessment of the user requirements and functions.  The Dissolution options is off the shelf so you could consider vendor testing acceptable but you would still want to PQ that it meets specific user requirements - similar to what Deigipciaco did.  In any case where you decide to do less functional testing you should understand and document why (in the RA) so when the auditor comes knocking you have a ready answer instead of trying to remember the reasoning from years ago.  
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