No matter their size, discipline, or position in the discovery pipeline, research pathology labs have a common need to record and report data. For laboratories operating in regulated nonclinical environments, compliance with Good Laboratory Practice (GLP) principles regarding study recording and reporting is essential. Demands may be less rigorous in laboratories not engaged in regulated research, yet staff in these labs still need to track who is accessing their systems, what actions are being taken, and, if questions arise, when data has been changed. In both environments, ensuring the accuracy, consistency, reliability, and audibility of scientific data is key.

As laboratories work to fulfill their data integrity requirements, digital pathology adoption can significantly streamline workflows and improve the accuracy and depth of recorded data. In this blog post, we share how the new Compliance Add-on available in HALO Link 4.0 can help laboratories promote data best practices through auditing and reporting

HALO Link and System-Wide Auditing

Indica Labs’ platform for collaborative pathology, HALO Link, is a browser-based hub for pathology that helps research organizations worldwide to safely and securely manage, share, and analyze digital slides and data. HALO Link incorporates images, metadata, and image analysis using a flexible study-based architecture and offers limitless data organization with extensive search capabilities, an advanced browser-based viewer with robust annotation tools, and seamless collaboration. Industry leading AI-powered image analysis is available through integration with HALO® and HALO AI.

Indica Labs launched the Compliance Add-on with HALO Link 4.0 to support organizations needing auditing and reporting in digital pathology. The Compliance Add-on is designed to be used alongside an organization’s standard operating procedures (SOPs) to aid adherence to GLP or internal data integrity frameworks.

The core features of the Compliance Add-on are robust system-wide auditing and reason for change capture. With system-level auditing, every action that either triggers new data generation or alters existing data is recorded. This includes study, slide, annotation, and metadata actions in HALO Link, as well as the creation or alteration of analysis and classifier settings in HALO.

The auditing process captures in-depth detail. For each action, the system logs a timestamp, a description of the event, the original data value (if applicable), the new data value, and the identity of the operator. Additionally, if configured, each entry will record a reason for the change, providing an extra layer of traceability.

Study owners can export audit logs for their studies, while administrators can access system-wide audit trails in the HALO Link Admin Dashboard alongside information on active jobs and requests, login attempts, and other data. Within the Admin Dashboard, admins can sort and filter audit data by specific users, actions, or dates. Both study and system audit trails can be easily exported as CSV files, facilitating further analysis or archiving.

Reason for Change Capture

The reason for change feature, the second core functionality of the Compliance Add-on, applies to all studies and trays within the system. This feature is designed to minimize workflow disruptions, only prompting users to input a reason for change during their initial access to a study or tray post-login. As users navigate through their workflow, they can update the reason for change at any time, ensuring that every data modification is accounted for and justified.