Improving the Data Integrity of Spectrometers-FDA perspective.
Data integrity refers to the completeness of data, with nothing missing or inconsistent. In other words, not only the data itself but also the metadata (the results of work that require human intervention, such as specifying conditions and analyzing analysis data) must be presented in a visible form, and verified together with the data. This is achieved by the Report Set.
Why Data Integrity Is Important?
The following warning letters have been issued by the FDA, demanding swift response regarding analytical instruments that do not support data integrity.
Warning Letter: 320-17-25 Issue Date: February 24,
2017
Investigator observed that your laboratory systems lacked controls to prevent
your staff from altering or deleting electronic data. Analysts manipulated and
deleted audit trails. You lacked adequate controls for all HPLC, gas
chromatography, and ultra-violet systems.
Warning Letter: 320-17-01 lssue Date: October 13,
2016
In response, to this letter, provide details of your retrospective review of
HPLC and other laboratory data, such as Fourier transform infrared
spectroscopy, gas chromatography, UV spectrophotometry, and (b)(4)
analyzer data.
Warning Letter: 320-15-09 lssue Date: April 6, 2015
Laboratory lacked controls to prevent
the unauthorized manipulation of your laboratory’s electronic raw data.
Specifically, your infrared (IR) spectrometer did not have access
controls to prevent deletion or alteration of raw data.