Mandatory Part 11 Risk Assessment Could Cost Industry Billions

The drug, biologics and device industries could face billions in additional costs if the FDA includes risk analysis requirements in electronic recordkeeping regulations, an industry consultant says.

The agency seems likely to publish a rule by the beginning of next year requiring companies to do risk analysis as part of meeting their Part 11 requirements, Martin Browning, president of EduQuest, said at FDAnews’ Nov. 2 “FDA Inspections Summit.” But industry is in the dark about this. This development is “under the radar” and industry is likely to be caught unaware, failing to anticipate the additional costs, he told PIR.

Costs Could Overwhelm Benefits

While the risk factors will be used to determine whether a company can receive regulatory relief from some of the burdens associated with validating its data, the costs will likely overwhelm any benefit, Browning said.

The cost of assessing the risks associated with industry recordkeeping could be billions because companies lack a formal, documented risk analysis system, he added. The lack of such a system would result in far more information being necessary to assess risk than to electronically document the records themselves.

The FDA first issued the Part 11 rule in 1997, but it was almost immediately criticized for its breadth and vagueness. Designed to stimulate regulated companies to embrace electronic record technology, the original iteration of the rule actually stunted its growth, critics charged. The FDA tacitly agreed when it issued what some experts labeled a “kinder, gentler” Part 11 in August 2003 that narrowed and clarified its scope. Industry generally applauded the 2003 revision.

Risk assessment also seemingly goes beyond the original scope of Part 11, which was to ensure the integrity of electronic data as compared to paper files, Browning said. The risk analysis rule would require more assurances of integrity for electronic data than its paper counterparts. — Stephen Langel