Chain of custody in the lab refers to the documented process of tracking the handling, storage, and transfer of samples or data throughout their lifecycle. It ensures sample integrity, traceability, and accountability, which are critical for producing reliable results and maintaining compliance with regulatory requirements.
This process is especially important in regulated industries such as pharmaceuticals, clinical research, forensics, and biobanking, where any gaps in sample traceability can lead to data inaccuracies, regulatory penalties, or invalidated studies. For example, in clinical trials, chain of custody ensures that patient samples are securely handled from collection to analysis. Similarly, in biobanking, it helps monitor sample usage over years or decades.
Effective chain of custody management requires capturing key information at every step, such as:
Here’s how to turn chain of custody from a concept into a repeatable practice. Start with a few non-negotiables (required fields, controlled terms, automatic captures) to cut errors and speed reviews. Then use the example entry as a model for what “good” looks like—clear, complete, and defensible during audits.
Example entry (what “good” looks like)
Modern sample management and LIMS softwares are designed to simplify and automate these steps. Features like barcode scanning, digital signatures, and automated audit trails ensure every action is logged in real time. This not only reduces human error but also provides a clear, tamper-proof record for audits or quality checks. Additionally, user access controls in such software prevent unauthorized access, ensuring sensitive samples remain secure.
By integrating chain of custody management into your lab’s software, labs can reduce administrative burdens while improving compliance with standards like Good Laboratory Practices (GLP), ISO 17025, or FDA 21 CFR Part 11. Advanced integrations with lab instruments and storage systems allow for automated tracking of environmental conditions and sample storage, ensuring proper handling throughout the process. And for labs managing high volumes of samples or working in highly regulated fields, chain of custody tools within their sample management software offer peace of mind, efficiency and accountability.
For labs looking to enhance sample organization and traceability, LabKey offers two reliable options.
Sample Manager provides barcode scanning, storage location tracking, and automated audit trails to simplify chain of custody and cut manual errors—ideal for teams with straightforward workflows that prioritize efficiency and accuracy without complex integrations.
LabKey LIMS builds on these strengths with advanced workflow planning, equipment and assay management, and broader configurability for labs that need end-to-end standardization.
Whether you’re managing biobank inventories, research samples, or routine operations, both solutions help ensure your samples are handled securely and remain fully traceable.
