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The FDA’s long-awaited revision of Part 11, which is now slated for release this year, will impose major new burdens on industry in the area of risk assessment and management, according to Martin Browning, president of EduQuest and a former FDA official.
The FDA’s long-awaited revision of Part 11, which is now slated for release this year, will impose major new burdens on industry in the area of risk assessment and management, according to Martin Browning, president of EduQuest and a former FDA official.
The FDA’s long-awaited revision of Part 11, which is now slated for release in the first part of 2007, will impose major new burdens on the pharma industry in the area of risk assessment and management, according to Martin Browning, president of EduQuest and a former FDA official.
The FDA’s long-awaited revision of Part 11, which is now slated for release in the first part of 2007, will impose major new burdens on the pharma industry in the area of risk assessment and management, according to Martin Browning, president of EduQuest and a former FDA official. Read More
The drug, biologics and device industries could face billions in additional costs if the FDA includes risk analysis requirements in electronic recordkeeping regulations, an industry consultant says.
Joseph Famulare, the FDA’s acting deputy director, Office of Compliance, and one of the agency leaders in advocating and articulating erecord integrity, discussed the state of 21 CFR Part 11 and the FDA’s once and future expectations Nov. 2 with PIR.
While acknowledging that the original 1997 21 CFR Part 11 Rule was "broadly interpreted" and not risk-based, George Smith, consumer safety officer at the FDA, has reminded people in the past several months that the rule and the agency's commitment to edata integrity and retrievability are still important.
The drug, biologics and device industries could face billions in additional costs if the FDA requires risk analysis to be part of electronic recordkeeping regulations, an industry consultant says.
The drug, biologics and device industries could face billions in additional costs if the FDA requires risk analysis to be part of electronic recordkeeping regulations, an industry consultant says.
Achieving a "paperless" lab takes enormous work, including substantial procedural and possibly organizational changes, but the effort can pay off in a year and provide benefits far beyond 21 CFR Part 11 compliance, experts told PIR last week.