Date Published:
Thu, 04/01/2010This 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.
For direct application to computers and software, see sections:
- 58.3(k) definition of raw data
- 58.33(f) raw data archival
- 58.51 data storage
- 58.51 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