Source: http://community.pharmamanufacturing.com/content/rethinking-part-11-fda-plays-it-coy
Timestamp: 2013-05-19 22:32:33
Document Index: 97174387

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

Rethinking Part 11: FDA Plays It Coy | PharmaManufacturing Community
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What this effort is not, he noted:• an “initiative”• a survey or study• additional scheduled inspections• a report shared publicly (nothing formal will be provided)• a standard approach for future Part 11 inspections
And the non-initiative has no end date. “We may keep this going for a while,” he said. Next Steps?
What are the next steps? Smith wouldn’t say, but offered the following possibilities:• Keeping the status quo, plus publishing additional guidance focused on issues of concern• Amending the existing Part 11 regulation and/or preamble• Proposing new wording/language to existing CPGs (compliance policy guides for inspectors) and CPMGs that contain outdated interpretations of Part 11• Revoking the current Part 11 scope and applications guidance• Amending the current Part 11 scope and applications guidance