Erecord Assurance Becoming 'More Important,' Expert Says

Meeting the demands of electronic record assurance is becoming more important for FDA-regulated life sciences companies, InfoStrength President Rita Geiger told PIR last week. “The FDA is looking for industry to protect its edata integrity.”

Erecord assurance programs should be about having the ability to implement “flexible, agile safeguards” with current technology that provide “integrity and authenticity” for edata, she said.

And don’t let regulations alone drive your strategy, she said. “This is not just about regulatory changes or Part 11.” Savvy companies recognize the business case for protecting edata, and also understand that there have been significant changes in technology that protect and threaten edata.

However, regulations, especially those outside the U.S., are increasingly important as companies take on more partners and customers all over the world, Geiger said. “The environment for them is in constant flux.”

FDA-regulated life sciences companies must also be aware that traditional computer system validation methods don’t work as well today because so many companies are using off-the-shelf software, Geiger advised.

Geiger is hosting FDAnews’ Information Management Summit, Information Assurance: The New Path to Competitive Advantage Nov. 29–Dec. 1 in Bethesda, Md. The summit is designed to help life sciences companies address challenges of the revised Part 11.More information about the summit can be found at www.fdanews.com/wbi/conferences/infosummit.html. — Michael Causey