Laboratories can improve the efficiency of their operations and ensure the accuracy of their data reporting, by automating the transfer of information between their chromatography data system (CDS) and their laboratory information management system (LIMS). In addition, the security of their chromatography data is enhanced when this automation is accomplished within the security framework established by regulatory guidelines such as the U.S. Food and Drug Administration’s ruling on electronic signatures and electronic records (21 CFR Part 11). This case study describes how Labtronics LimsLinkCDS enables laboratories to, smoothly and securely, integrate Agilent Cerity for Pharmaceutical QA/QC with any LIMS.
This document details how to integrate Agilent Cerity for Pharmaceutical QA/QC with Laboratory Information Management Systems (LIMS) using the Labtronics LimsLink interface. It addresses the need for automated, secure data transfer that complies with regulatory guidelines such as 21 CFR Part 11, replacing manual transcription and custom coding.
The Expansion Function inserts control samples after every 4 regular samples.
The header includes the date, time, and user ID obtained from the Operating System.
The interface incorporates electronic signatures, password protection, and a full audit trail.