http://blogs.fda.gov/fdavoice/index.php/2012/02/50-years-after-thalidomide-why-regulation-matters/

http://www.fda.gov/Drugs/NewsEvents/ucm320924.htm

http://blog.ispe.org/data-quality-and-data-integrity-what-is-the-difference

Failure to prevent unauthorized access or changes to data […]

[…] additional testing was performed but not properly documented […]

http://www.fda.gov/iceci/enforcementactions/warningletters/2016/ucm501282.htm

http://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm401451.htm

All analysts shared a common login ID & password.

http://www.fda.gov/iceci/enforcementactions/warningletters/2016/ucm516163.htm

[…] raw data files in the recycle bin […] even in the presence of 'Do Not Delete Any Data' notes […]

http://www.fda.gov/iceci/enforcementactions/warningletters/ucm455345.htm

Warum? Entscheidungsgrundlage & Ursachenforschung im Problemfall (Bia 10-2474 in Rennes)

vulnerability of data to involuntary or deliberate amendment, deletion or recreation

of data [plus] relevant metadata […] should be documented

verified copies of all raw data, metadata, relevant audit trail, result files [plus] configuration settings […] necessary for reconstruction of a given raw data set

chronology of the 'who, what, when, and why' of a[n electronic] record

Regulierer & Pharmafirmen fokussieren auf Datenintegrität

Git & Co. == Datenintegrität, aber in Pharma unbekannt