GenoLogics Life Sciences Software has announced the availability of Clarity LIMS 3.1. In addition to providing support for HIPAA-covered entities, Clarity LIMS extends its toolset for labs working with patient populations with features that support clinical compliance.
Version 3.1 further supports the needs of these labs with electronic signatures, configurable permissions, and detailed audit trail reporting.
To help labs conduct operations electronically, regulating agencies, such as the FDA, have published standards-21 CFR Part 11 is one-that describe how electronic approvals or signatures should be recorded.
Clarity LIMS is designed to this standard and allows labs to configure electronic signature requirements, without developer intervention, which supports compliance yet speeds implementation. Furthermore, Clarity LIMS prevents processes that are missing required approvals from moving forward.
21 CFR Part 11 also requires that systems restrict functionality to users with appropriate permissions to prevent error, data loss, or tampering. Clarity LIMS meets this requirement with configurable role-based permissions, preventing access where not needed.
Adding to this security is the system’s ability to produce a human readable audit trail that details all system events, who performed the events, and when. A record of the previously recorded data is also kept if the event involved a change to data.
“We are proud to release version 3.1 of Clarity LIMS and further support compliance requirements,” states Michael Ball, CEO of GenoLogics. Ball adds, “These features reiterate our dedication to make next generation sequencing a mainstay in clinical environments.”