This section addresses the computerized systems and data controls supporting analytical laboratory operations. It covers instrument software validation, electronic records, user access, audit trails, data processing, LIMS qualification, system interfaces, backup and recovery, archival, migration, and analytical data lifecycle integrity.
Analytical instrument software controls instruments, acquires signals, creates electronic records, processes analytical data, performs calculations, applies acceptance criteria, supports review, and transfers results to other regulated systems. Validation should demonstrate that the complete computerized analytical process performs as intended and…
Analytical laboratory systems generate more than final test results. They also create raw data, metadata, instrument methods, processing methods, sample sequences, calculations, audit trails, electronic signatures, configuration records, and security events. Together, these records provide the context needed to reconstruct…
A laboratory information management system (LIMS) controls laboratory information across sample receipt, testing, review, approval, reporting, retention, and disposition. Depending on its intended use, a LIMS may manage sample identities, specifications, analytical methods, worksheets, calculations, stability studies, instrument interfaces, results,…
An analytical instrument–laboratory information management system (LIMS) interface transfers laboratory information between an instrument data system and LIMS. The transferred information may include sample identifiers, test assignments, analytical results, units, status, timestamps, method identifiers, instrument identifiers, and review information. An…
Analytical laboratory systems generate more than final reported results. The complete electronic record may include raw data, processed data, metadata, methods, sequences, calculations, audit trails, electronic signatures, instrument configuration, sample relationships, reports, and system-generated status information. These records may initially…