FDA 21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies

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This part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products.

The sections most directly ﾠapplicable to computers and software include:

• 58.3(k) definition of raw data
• 58.33(f) raw data archival
• 58.51 data storage
• 58.81 deviation documentation with raw data
• 58.185 Reporting of study results
• 58.190 Storage and retrieval of records and data
• 58.195 Retention of records