Electronic Data Integrity in the Drug-Development Process


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View on Data Integrity

In an exclusive to PharmaVOICE, Peter M. Smith, Ph.D., Project Manager at Taratec Development Corp., discusses the importance of electronic data integrity in the drug-development process.
In August 2003, the FDA restated its guidelines on 21 CFR Part 11 regulation and a more narrow interpretation was given, prompting a more pragmatic approach to electronic data integrity based on risk assessments. Various interpretations of this approach remain, and there are ongoing discussions between the FDA and industry representatives as to the long-term form of the regulation. Even though the explicit Part 11 rules remain in question, the need to ensure the integrity of electronic data has not gone away.
There are huge costs and time pressures involved in preparing data to support submission to the Food and Drug Admistration for approval of a drug candidate before marketing. To avoid any temptation to cut corners or make misguided claims, the FDA reviews and challenges the submitted data for truth and accuracy.
“This is the part of the checks and balances built into any open system,” says Peter M. Smith, Ph.D., project manager at Taratec Development…

Expert on this Topic
Peter M. Smith, Ph.D., Project Manager, Taratec Development Corp.