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 In February, FDA withdrew part 11 guidances and a compliance policy guide and issued an interim draft guidance that announced a number of part 11 requirements would be subject to FDA "enforcement discretion" while FDA reviewed the reg (3"The Gray Sheet" March 3, 2003,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 FDA "currently does not intend to re-issue these draft guidance documents or the CPG," the new guidance notes...
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Part 11: FDA plans to publish draft guidance on use of computerized systems in clinical trials by the end of August. The "Part 11" draft guidance will replace a guidance on the same topic published in April 1999 and align the guidelines with policy articulated in FDA's broader guidance released in August 2003: "Part 11, Electronic Records; Electronic Signatures - Scope and Application" (1"The Gray Sheet" Sept. 8, 2003, In Brief). The forthcoming draft guidance is expected to outline general principles that should be followed when computerized systems are used to create, modify, maintain, archive, retrieve or transmit clinical trial data to ensure that electronic records meet regulatory standards and requirements. Many of the guidance's general principles are expected to address clinical trial electronic record security...
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