21 CFR 58.190: Storage and retrieval of records and data
Requires testing facilities to retain all nonclinical study raw data, documentation, protocols, reports, and specimens in access-controlled, indexed archives under a designated responsible individual, with storage conditions that minimize deterioration and allow expedient retrieval.
Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies · Subpart J, Records and Reports
Recent 483s citing 58.190
- BASF Corporation · East Setauket, New YorkThe study director failed to assure that all raw data and documentation were… May 29, 2025
- Ricerca Biosciences, LLC · Painesville, OhioConditions of storage failed to minimize deterioration of the documents in… Aug 13, 2021
- Joinri'Laboratories Co., Ltd · Beijing, ChinaThe study director failed to assure that all raw data, documentation, protocols,… Sep 20, 2013
- ASEGUA THERAPEUTICS LLC · Foster City, CaliforniaFailure to conduct a re-injection reprodt eriment during pre-study method… Dec 9, 2011
The regulation text
§ 58.190 Storage and retrieval of records and data.
(a)All raw data, documentation, protocols, final reports, and specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids) generated as a result of a nonclinical laboratory study shall be retained.
(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 be retained elsewhere provided that the archives have specific reference to those other locations.
(c)An individual shall be identified as responsible for the archives.
(d)Only authorized personnel shall enter the archives.
(e)Material retained or referred to in the archives shall be indexed to permit expedient retrieval.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002]
Questions
What does 21 CFR 58.190 require?
Requires testing facilities to retain all nonclinical study raw data, documentation, protocols, reports, and specimens in access-controlled, indexed archives under a designated responsible individual, with storage conditions that minimize deterioration and allow expedient retrieval.
Which sections are cited alongside 58.190?
In the same 483s, investigators most often also cite 58.35 (Quality assurance unit), 58.33 (Study director), 58.63 (Maintenance and calibration of equipment), 58.130 (Conduct of a nonclinical laboratory study).