Second-Generation Software for -80˚C Sample Access Manager Supports Chain of Custody and 21 CFR Part 11

Hamilton Storage Technologies introduces new sample management and tracking software for its automated -80°C Sample Access Manager (SAM), providing functionality and documentation to support chain of custody and 21 CFR Part 11 requirements. The new program offers a wide range of reports and access control functions, from high-level administrative creation of user groups and rights to detailed audit trails of individual samples. The new SAM software enables customers to safely store compounds and biological samples with back-up reports to document administrator-determined levels of information detail.

Password login ensures that users can only access samples for which they are authorized. The system includes electronic signature capability for 21 CFR Part 11 applications.

In cherry-picking applications, each time the sample is removed from storage a complete log is updated as to who took it out, who returned it and how long it was out of the -80˚C environment. SAM can also create a log of the temperatures the sample was exposed to while it was in and out of storage, which is especially important in clinical trial and diagnostic applications.

“This new software, with its flexible configuration options and library of reports, is ideal for regulated environments,” commented Matt Hamilton, vice president of Hamilton Storage Technologies. “Chain of custody and 21 CFR Part 11 compliance support are new to the cold storage marketplace and were developed in response to customer needs.”

A high-level report can be created at any time for any sample showing how long it has been in the system, how many times it has been taken out, how long it was out, along with a complete temperature history. A complete audit trail report can be produced for any specific sample making it ideal for forensics applications. The administrator can set thresholds and alarms for desired sample storage and handling conditions. The system can also produce a regular diagnostic report for the service administrator.

The -80˚C SAM ensures sample integrity by maintaining a precise storage environment at user-determined levels, between -60˚C and -80˚C. The system offers sample format flexibility, cherry-picking, sample tracking and easy-to-use software all within a compact footprint. The -80˚C can handle microplates or a variety of tube sizes and is ideal for the storage of nucleic acids, tissues, proteins and compounds.