FDA Computer System & Software Validation - What You’ve Known For 20 Years Is Changing
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FDA Computer System & Software Validation - What You’ve Known For 20 Years Is Changing
In 2019, FDA will be releasing a new, draft guidance “Computer Software Assurance for Manufacturing, Operations, and Quality System Software” that updates 20 year legacy guidance documents found in 21 CFR Part 11 relating to medical device computer system validation and software validation.
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TULFO ALLEGES BRIBERY AT FDA Senator Raffy Tulfo on Tuesday accused the Food and Drug Administration (FDA) of favoring multinational pharmaceutical companies over small local businesses, alleging that bribery influences product approvals. “Kapag maliit na kumpanya, hindi ninyo inaaprubahan, iniipit ninyo. Pero kapag malaking pharmaceutical company, lalo na multinational, approve kayo nang approve. Why? Because may mga lagay,” Tulfo said. 🎥 Senate of the Philippines | Bilyonaryo News Channel
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