Scientific Solutions, LLC is your premier choice for archiving in the twin cities metro area. Our secure GLP compliant archive facility is monitored for temperature and humidity daily so that your samples and raw data will be maintained appropriately, per FDA regulation 21 CFR, part 58:
§ 58.51 Specimen and data storage facilities.
Space shall be provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies.
§ 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.
§ 58.195 Retention of records.
(a) Record retention requirements set forth in this section do not supersede the record retention requirements of any other regulations in this chapter.
(b) Except as provided in paragraph (c) of this section, documentation records, raw data and specimens pertaining to a nonclinical laboratory study and required to be made by this part shall be retained in the archive(s) for whichever of the following periods is shortest:
(1) A period of at least 2 years following the date on which an application for a research or marketing permit, in support of which the results of the nonclinical laboratory study were submitted, is approved by the Food and Drug Administration. This requirement does not apply to studies supporting investigational new drug applications (IND’s) or applications for investigational device exemptions (IDE’s), records of which shall be governed by the provisions of paragraph (b)(2) of this section.
(2) A period of at least 5 years following the date on which the results of the nonclinical laboratory study are submitted to the Food and Drug Administration in support of an application for a research or marketing permit.
(3) In other situations (e.g., where the nonclinical laboratory study does not result in the submission of the study in support of an application for a research or marketing permit), a period of at least 2 years following the date on which the study is completed, terminated, or discontinued.
(c) Wet specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids), samples of test or control articles, and specially prepared material, which are relatively fragile and differ markedly in stability and quality during storage, shall be retained only as long as the quality of the preparation affords evaluation. In no case shall retention be required for longer periods than those set forth in paragraphs (a) and (b) of this
(d) The master schedule sheet, copies of protocols, and records of quality assurance inspections, as required by § 58.35(c) shall be maintained by the quality assurance unit as an easily accessible system of records for the period of time specified in paragraphs (a) and (b) of this section.
(e) Summaries of training and experience and job descriptions required to be maintained by § 58.29(b) may be retained along with all other testing facility employment records for the length of time specified in paragraphs (a) and (b) of this section.
(f) Records and reports of the maintenance and calibration and inspection of equipment, as required by § 58.63(b) and (c), shall be retained for the length of time specified in paragraph (b) of this section.
(g) Records required by this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records.
(h) If a facility conducting nonclinical testing goes out of business, all raw data, documentation, and other material specified in this section shall be transferred to the archives of the sponsor of the study. The Food and Drug Administration shall be notified in writing of such a transfer.
Let us take the worry away. In the twin cities metro area, we will come to your facility, package the materials in the most cost-efficient manner, inventory all items, create a chain of custody, and courier your items back to our secure and monitored archive facility. Nationally, you can send your items to our office for subsequent packaging for efficiency, and inventory verification. Your items will be received into our database and conscientiously archived into our facility. Also, in the twin cities metro area, when items are requested from the facility, we will complete the appropriate documentation and drive the items to your facility. Nationally, we will ship them via FedEx or UPS at your request.
Good Laboratory Practices (GLP) Reference Documents & Links (http://www.gpo.gov/fdsys/granule/CFR-2011-title21-vol1/CFR-2011-title21-vol1-part58) 21 CFR 58 – GLP for Non-clinical Laboratory Studies