What is 21 CFR Part 11?

What is 21 CFR Part 11?

21 CFR Part 11 is a regulation by the FDA that establishes the criteria for electronic records and electronic signatures to be considered trustworthy, reliable, and equivalent to paper records.…

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Explain deviation.

Explain deviation.

In the pharmaceutical industry, a deviation is a difference between an observed value and an expected value for a product or process condition. Deviations can also be a departure from…

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Explain BTGN.

Explain BTGN.

BTGN (Bile-Tolerant Gram-Negative bacteria) refers to a group of Gram-negative bacteria that can grow in the presence of bile salts. It is mainly used as an indicator of hygiene and…

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