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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In 2019, FDA will be releasing a new, draft guidance “Computer Software Assurance for Manufacturing, Operations, and Quality System Software” that updates 20 year legacy guidance documents found in 21 CFR Part 11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.

2018年12月2日

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FDA explains 5 to know about the drug approval process

FDA explains 5 to know about the drug approval process

2017年5月9日

Pfizer Covid-19 vaccine enters FDA approval process

Pfizer Covid-19 vaccine enters FDA approval process

2020年11月21日

Fact Finders: Breaking down the steps to get full FDA approval

Fact Finders: Breaking down the steps to get full FDA approval

2021年5月1日

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Definition of computer system validation

Definition of computer system validation

2020年1月14日

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Complete guide to computer system validation in 2026

2022年10月5日

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Computer System Validation: Your Path to Documenting Data Integrity

2021年9月1日

The FDA has given the green light to a pill version of the blockbuster weight-loss drug Wegovy, the first daily oral medication to treat obesity. One man who participated in the clinical trial for the drug is sharing his experience. | CBS News

The FDA has given the green light to a pill version of the blockbuster weight-loss drug Wegovy, the first daily oral medication to treat obesity. One man who participated in the clinical trial for the drug is sharing his experience. | CBS News

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Definition of computer system validation

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2024年8月28日

getreskilled.com

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Computer System Validation (CSV): Your Path to Documenting Data Integrity (copy)

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2023年8月10日

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2024年8月15日

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