Part 11 rulemaking planned
This article was originally published in The Gray Sheet
Executive Summary
Updated 1electronic records guidance includes clarification on legacy systems, time stamps and FDA's enforcement discretion policy, as well as an added reference to ISO risk management standard 14971. Accompanied by a 2Sept. 5 Federal Register notice, the August guidance notes that FDA "anticipate[s] initiating rulemaking to change part 11." The decision to alter the electronic records rule stems from the agency's good manufacturing practices initiative for pharmaceuticals. In February, FDA withdrew part 11 guidances and a compliance policy guide and issued an interim draft guidance that announced a number of part 11 requirements would be subject to FDA "enforcement discretion" while FDA reviewed the reg (3"The Gray Sheet" March 3, 2003, p. 7). FDA "currently does not intend to re-issue these draft guidance documents or the CPG," the new guidance notes...