GxP Compliance Support With LabTwin
October 24, 2024
LabTwin is built on three pillars—its AI-powered large language model, its integration with the lab informatics landscape, and its support for general good practices (GxP); whether those be manufacturing, clinical, laboratory, or documentation. Previous blog posts described how the AI features in the LabTwin voice-powered digital lab assistant support the Lab of the Future and how LabTwin integrates with other systems and instruments. Here, we’ll look at the third pillar that underlies LabTwin’s software, support for GxP organizations. This support is provided by ensuring compliance and supporting good practices, two functions that overlap.
Ensuring Compliance and Data Integrity
Ensuring regulatory compliance and maintaining data integrity is an understandably crucial concern in many labs. The LabTwin digital lab assistant facilitates documentation and data security. LabTwin can help your scientists generate accurate and organized documentation and reports of experiments and results. LabTwin also simplifies the creation of audit trails and the maintenance of regulatory compliance. For example, LabTwin is compliant with the U.S. Food and Drug Administration (FDA) regulation 21 CFR Part 11, for electronic recordkeeping.
Good laboratory practices (GLP) are assessed by the ALCOA framework, an acronym that stands for attributable, legible, contemporaneous, original, and accurate. LabTwin supports this framework with its access control and accurate data capture. Records of all actions taken in the lab can be captured as they happen, at the bench. ALCOA+ adds Complete, Consistent, and Enduring to the original framework; LabTwin’s records are compliant with these additions as well.
The LabTwin digital lab assistant ensures data security and privacy through encryption and access control with ISO 27001 and 27017 certifications. LabTwin is hosted by Amazon Web Services and all data sent over the Internet to LabTwin servers and between various services is encrypted with TLS/SSL connections. These features play an important role in maintaining data integrity and protecting intellectual property.
Supporting Good Practices
The basics of good practices (in whatever setting they are applied) are the same across the globe. These baseline practices (manufacturing, clinical, laboratory, documentation) help to ensure the quality of the final product, whether that is a medicine, a food, or a cosmetic, among many other consumer goods. LabTwin supports these GxP environments.
LabTwin’s voice-capture capabilities ensure complete documentation no matter where the technician is making notes. In clinical labs, it isn’t necessary to remove personal protective equipment (PPE) to record observations in settings where methods must be conducted in the dark, such as fluorescence microscopy, the voice-powered data capture that the LabTwin digital lab assistant improves the reliability and accuracy of the experimental results. In any regulatory setting where both of a technician’s hands may be needed to ensure the safety of the experiment or process, this voice-capture ability is crucial.
Modernize Your Laboratory With LabTwin
The three pillars of the LabTwin digital lab assistant work together to add functionality and accuracy to any lab. You can perform more efficiently, safely, and securely with LabTwin’s AI-enabled and voice-powered features.