Regulations and Guidelines
Showing 129–133 of 133 results
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FDA Compliance Policy Guide 425 Computerized Drug Processing, 9/87
1987 guide explains the FDA policies on regulatory issues including (cGMP) regulations. Sub-chapter 425 contains the policies for Computerized Drug Processing.
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FDA Guide to Inspection of Computerized Systems in Drug Processing, 2/83
February, 1983 guidance to inspectors regarding how to audit system hardware, software, networks, and procedures.
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FDA Guidance: Good Laboratory Practice – Q&A, 6/81
Compilation of questions and answers regarding Good Laboratory Practice Regulations from the years 1997-1981.
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FDA Inspector’s Technical Guide: The Computer in FDA Regulated Industry Part II, 9/77
Part II of the 1977 FDA technical resource for inspectors focuses on computer hardware.
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FDA Inspector’s Technical Guide: The Computer in FDA Regulated Industry, 5/76
1976 FDA technical guide for inspectors explains CRTs, punch cards, and the difference between analog and digital computers.
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