CFR section

21 CFR 58.190(b): Storage and retrieval of records and data

PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart J-Records and Reports

Key facts

Citation 21 CFR 58.190(b)
Section Storage and retrieval of records and data
Part PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
Subpart Subpart J-Records and Reports
Subchapter 21 CFR A General
Product types cited Devices, Drugs, General
Regulation text (excerpt) (b) There shall be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Conditions of storage shall minimize deterioration of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents or specimens. A testing facility may contract with commercial archives to provide a repository for all material to be retained. Raw data and specimens may…

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