Documents reveal FDA's use of computer forensics to uncover data falsification

Some software used to track drug production testing data presents technicians with a temptation--a delete key. Hit the button and the negative results disappear, freeing the worker to substitute in positive data and ship the suspect batch. The catch? It takes more than a delete key to truly erase data.

Sun Pharmaceutical Industries has learnt about the resilience of data the hard way. In 2011, a Sun Pharma technician gave into temptation, hit the delete key and generated new, positive data from another sample within the same batch, Bloomberg reports. The problem of the questionable impurity data seemingly disappeared, but the truth lay hidden in the hard drive. In 2013, the FDA uncovered what had happened and tasked its computer forensics experts with finding other such events.

The team discovered 5,301 more deleted chromatography results from the same facility. "Our review found that analysts regularly delete undesirable chromatographic results, and products are retested without initiating an investigation as required," FDA officials wrote in November 2013 in a previously undisclosed document. The data integrity failings echo those seen at Ranbaxy and other drugmakers in India. Sun Pharma said its data integrity practices have improved since the FDA warning letter.

Paper-based records present their own problems. The FDA struggled to access some physical documents during a December inspection of a Hospira ($HSP) plant. But, used properly, software can cut the risk of user malpractice. "One of the goals of compliant [chromatography data system] software is that controls are in place so data cannot be deleted, either accidentally or maliciously, and that the data is always maintained," Waters spokesperson Jeff Tarmy said.

- read the Bloomberg feature
- and its follow-up piece

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