As if a slowing economy and dwindling product pipelines weren’t enough to contend with, drug companies are under mounting pressure to face a regulatory issue that many compare to the “Y2K bug” of the late 1990s: compliance with the FDA’s 21 CFR Part 11 regulation. The ruling, which governs the security of electronic records submitted to the agency, has been in place since 1997, but the FDA is only just beginning to crack down on companies who fail to meet the minimum validation requirements (see sidebar, p. 9).

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