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“If it’s not documented, it didn’t happen”


This is a well known saying to Quality teams in biotechnology. What it means is that every step in the development, clinical, and manufacturing processes needs to be documented or else regulators can’t accept that it happened. In the eyes of the FDA, without documentation, the research, the clinical trials, or the manufacturing process needs to be repeated. This results in added expense, costly delays, and an erosion in trust from regulators, investors, and consumers.


In this piece, we will chronicle the nine elements that successful Quality & Compliance teams adopt to keep pace with the speed of discovery. Learn the best practices for an effective quality documentation process.

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Leader Data Security for Winter 2021
Egnyte Ranked #1 for Data Security by G2

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