Bioequivalence and Bioavailability Forum

No audit trail in most software [Software]

posted by Helmut  – Vienna, Austria, 2014-07-01 14:12 (4373 d 12:09 ago) – Posting: # 13186
Views: 6,596

Hi Ken,

❝ How do we prove that R has audit trail ?

You can’t – there is none (like in SAS, Matlab, S-Plus, Phoenix/WinNonlin, ). Have a look at this docu­ment.* The only software having an audit-trail out of the box are all LIMS and some CDS.

❝ For example, if we use Bear or PowerTOST in R, how do we provide to inspector audit trail ?

Tell the inspector that there is none. Have a set of SOPs which you follow. Provide a transparent work­flow documenting all steps performed.

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• The R Foundation for Statistical Computing
  R: Regulatory Compliance and Validation Issues
  A Guidance Document for the Use of R in Regulated Clinical Trial Environments
  Vienna, Austria (August 8, 2013)
  online

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• Audit trail in R Ken Peh 2014-07-01 05:37 
  • No audit trail in most softwareHelmut 2014-07-01 12:12
  • R with audit trail? ElMaestro 2014-07-01 13:17
    • May I try to hack it? Helmut 2014-07-01 17:51
      • May I try to hack it? ElMaestro 2014-07-01 18:42