Abstract
A chain of custody (COC) is required in many laboratories that handle forensics, drugs of abuse, environmental, clinical, and DNA testing, as well as other laboratories that want to assure reliability of reported results. Maintaining a dependable COC can be laborious, but with the recent establishment of the criteria for electronic records and signatures by US regulatory agencies, laboratory information management systems (LIMSs) are now being developed to fully automate COCs. The extent of automation and of data reliability can vary, and FDA- and EPA-compliant electronic signatures and system security are rare.
Highlights
A chain of custody (COC) is required in many laboratories that handle forensics, drugs of abuse, environmental, clinical, and DNA testing, as well as other laboratories that want to assure reliability of reported results
It is required in laboratories that handle samples bound by legal or regulatory directives, including those enforced by United States government agencies such as the Department of Transportation (US DOT), the Environmental Protection Agency (US EPA), and the Food and Drug Administration (US FDA). To meet those legal and regulatory requirements, many laboratories are required to keep detailed chain of custody records for all of the samples that move through their facilities
With laboratory information management system (LIMS) technology development and the establishment of regulatory standards for electronic records, manual systems are being replaced by electronic ones that are created and maintained by laboratory information management systems (LIMSs)
Summary
A chain of custody (COC) is the set of traceable records that provide unbroken control over a document, raw data, or a sample and its containers from initial collection to final disposal [1]. The principle US regulatory agency criteria for electronic recordsand signatures that were established to fill those needs include the United States Food and Drug Administration’s 21 Code of Federal Regulations Part 11 (21 CFR Part 11), released in 1997 [2, 3], and the ensuing United States Environmental Protection Agency’s Cross-Media Electronic Reporting and Recordkeeping Rule (the CROMERR Rule). Their establishment enabled the LIMS development needed for, and that has led to, secure electronic record keeping for COC. Several LIMSs currently provide tools for COC, though the reliability of tracking by those systems and the extent of automation of those systems vary widely
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