Part 11 Is "Unnecessarily Burdensome" And Should Be Revoked – Industry Group
This article was originally published in The Pink Sheet Daily
Executive Summary
Regulation of systems for electronic record keeping and electronic signatures can be achieved through existing law and predicate rules, the Industry Coalition on Part 11 asserts in citizen's petition.
You may also be interested in...
FDA To Inspect Industry's Electronic Record Keeping Systems
Pharma companies may have more to worry about than potential GMP violations when FDA inspectors show up at their door. The agency recently announced that it would begin conducting inspections to determine if industry is in compliance with the regulation governing electronic records and electronic signatures
Injectable Sterility Recalls Decline To Eight In 2004
Drug recall totals for 2004 dropped to their lowest levels in five years, helped by a sharp decline in sterility assurance-related problems among injectables. Overall, 170 drug products were included in FDA’s recall listings during 2004.