With Rampant Data Integrity Lapses, PDA Releases Code of Conduct

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, said Amgen Chief Quality Officer Martin Van Trieste during the Parenteral Drug Association annual meeting in San Antonio, Texas this week.

To combat the problem, PDA has worked with the FDA to create a Code of Conduct for Data Integrity.

PDA stresses that drugmakers not only train employees on the elements of the code, but also hold them accountable and 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.  Companies’ procedures should describe documentation control practices and retention requirements for both paper and electronic records.

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.

The 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.” Backdating entries on any record is prohibited.

The code also discusses 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.”

The code also covers steps companies should take — including hiring legal counsel or outside auditors to conduct independent investigations — if there is a suspected case of data falsification.

PDA’s code of conduct can be accessed at: www.pda.org. — Tamra Sami


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