With data integrity lapses becoming an endemic problem in the pharmaceutical industry, one organization is looking to tamp down the problem.
Although issues with data integrity are hardly new, the extent of the problem appears to be much bigger than industry experts ever imagined, Amgen Chief Quality Officer Martin Van Trieste said March 14 during the Parenteral Drug Association’s annual meeting in San Antonio, Texas.
To combat the problem, PDA has worked with the FDA to create a voluntary Code of Conduct for Data Integrity.
PDA stresses that drugmakers should not only train employees on the elements of the code, but also hold them accountable and remain vigilant in reporting questionable data.
Documentation procedures also figure prominently in the code. It stresses that employees should not be permitted to record raw data on unofficial forms, writing pads or other uncontrolled media.
The code also prohibits discarding, destroying, or modifying raw data or original records. If changes are required, the person making corrections must be identified, as well as the reason for the correction.
PDA’s code stresses the importance of employees signing original records in a contemporaneous manner “to accurately reflect who performed or witnessed the activity or who entered results or verified the accuracy of entries.”
Additionally, the code also addresses electronic data acquisition, validation and procedural controls governing data so that it can be traced through “every phase of its lifecycle.”
The code also recommends internal auditing to periodically evaluate the “quality system used for collecting, analyzing, reporting and retaining information and data.”
Other elements of the code cover investigations into alleged falsification of data, and the steps companies should take, including hiring legal counsel or outside auditors to conduct independent investigations. It also requires companies to notify regulators.
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