January 31, 2025
About LabKey
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:
- Who handled the sample or data?
- What happened?
- When did this action occur?
- Where was it transferred or located?
- How was the change made? Which protocol was followed?
- Were there any deviations from standard protocols?
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.
Streamline Chain of Custody with Sample Manager
For labs looking to enhance sample organization and traceability, Sample Manager offers a reliable solution. With features like barcode scanning, storage location tracking, and automated audit trails, Sample Manager simplifies the chain of custody process while reducing manual errors. It’s an ideal choice for labs with straightforward workflows that prioritize efficiency and accuracy without the need for complex system integrations.
Whether you’re managing biobank inventories, research samples, or routine lab operations, Sample Manager ensures your samples are handled securely and remain fully traceable. Take a tour to see how it can help your lab!
