Testing Strategy 495



  • SOX talks about… ‘A testing strategy is developed and followed for all significant changes in applications and infrastructure technology, which addresses unit-, system-, integration- and user acceptance-level testing to help ensure that deployed systems operate as intended’.
    We currently perform all kind of tests in a developement environment prior to perform these on production. But we lack of a written strategy.
    :?:
    Does anyone out there has a model or template I can use as a starting point?
    Thanks
    Matias



  • The pharmaceutical industry has prepared guidelines for documented testing of IT systems as part of System Development Life Cycle and Change Management. These guidelines were created to comply with other pharmaceutical regulations but are useful to also comply with SOx. Guidance documentation and forms are published by ISPE (www.ispe.org) as GAMP 4 rules, Guide for validation of automated systems, December 2001. Simple, detailed and widely accepted.



  • The pharmaceutical industry has prepared guidelines for documented testing of IT systems as part of System Development Life Cycle and Change Management. These guidelines were created to comply with other pharmaceutical regulations but are useful to also comply with SOx. Guidance documentation and forms are published by ISPE (www.ispe.org) as GAMP 4 rules, Guide for validation of automated systems, December 2001. Simple, detailed and widely accepted.
    Unfortunately, only accessible to memebers of the ispe 😞


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