Description
The LabChip GxP Software Kit delivers robust technical controls to ensure full compatibility with 21 CFR Part 11 requirements for electronic records and signatures. Designed to support regulated environments, the solution leverages two core components, the Central Data Repository (CDR) and the CFR database to maintain compliance and data integrity:
Comprehensive Data Protection: Safeguards assay data, analysis settings, event logs, and backup files from unauthorized editing or tampering.
Secure Storage Architecture: Stores all data securely in designated folders on the LabChip GX Touch computer, LabChip Reviewer computer, or a network server.
Central Data Repository (CDR): Provides a secure location for assay and data files.
CFR Database: Manages user accounts, audit trails, and data folder information.
Validated Database Management: Includes Microsoft® SQL Server® Express for creating and managing the CFR database, ensuring validated workflows and traceable audit history.
