FDA Guidance: Good Laboratory Practice – Q&A, 6/81
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In 1997, the CDER branch of the FDA published Guidance for Industry, Good Laboratory Practice Regulations – Questions and Answers. This document is a compilation of questions and answers from the years 1997-1981.
Although the information in this guidance document is many decades old, it’s still interesting to read because much of the content remains relevant.
Computer system topics addressed within this guidance document include:
- Page 4, Question 7: Are computer print outs raw data when the data was transcribed from a data sheet?
- Page 11, Question 8: What is the quality unit’s responsibility for data transcribed into a computer?
- Page 14, Question 5: To what extent do computer programs and procedures need to be documented?
- Page 22, Question 2: What are the GLP requirements for computerized data acquisition systems?
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