Electronic Archiving Offers Disaster Recovery Protection

Archiving tools for electronic records can help companies prepare for and better recover from data-damaging disasters, experts recently told PIR.

Given the devastation wrought by Hurricane Katrina and the prediction from many experts that 2006 will deliver an even more severe hurricane season, it is increasingly important for FDA regulated companies to protect their sensitive and proprietary edata, said Judith Beach, vice president and senior associate general counsel for regulatory affairs at Quintiles Transnational.

This can be particularly important if one’s firm is involved in a high number of clinical trials, Beach added.

Depending on how much data and documentation is archived electronically at a trial site, having edata archiving capability at the site or in other locations can “prevent catastrophic data loss,” she told PIR.

Another important wrinkle: The FDA’s new esubmission requirements prohibit firms from using the PDF format for esubmissions to the agency, noted Cassandra Kennedy, vice president of clinical quality assurance at Quintiles.

The Center for Drug Evaluation and Research had been accepting structured product labeling (SPL), as well as PDF, for the content of labeling since September 2004. But as of Oct. 31, 2005 it only accepts SPL for the content of labeling. Firms still using PDF will need to make the adjustment, said Beach.

Clinical trials in Louisiana and Mississippi were interrupted or ruined after Hurricane Katrina, Beach noted. In many cases, all data was lost and the trials will have to be redone. But if those trials had had edata archiving off-site, they likely would have been spared the worst, Kennedy and Beach agreed.