LIMS & Laboratory Glossary

LIMS
Laboratory Information Management System — software to manage samples, tests, results, instruments, and compliance records.
ELN
Electronic Lab Notebook — digital record of experiments and observations; often complementary to LIMS.
CAPA
Corrective and Preventive Action — quality process to address deviations and prevent recurrence.
OOS
Out of Specification — test result outside approved limits requiring investigation.
OOT
Out of Trend — result within spec but unusual compared to historical data.
COA
Certificate of Analysis — formal report of test results for a batch or sample.
NABL
National Accreditation Board for Testing and Calibration Laboratories — Indian accreditation body for testing labs.
ISO 17025
International standard for competence of testing and calibration laboratories.
21 CFR Part 11
US FDA regulation for electronic records and signatures in regulated industries.
GMP
Good Manufacturing Practice — quality system for pharmaceutical manufacturing.
GLP
Good Laboratory Practice — quality system for non-clinical safety studies.
GxP
Collective term for GMP, GLP, GCP and related good-practice regulations.
Audit Trail
Secure, time-stamped record of who changed what in a system and when.
Electronic Signature
Digital signature bound to a record with identity and intent, per 21 CFR Part 11.
Sample Login
Registration of a sample into the lab with ID, client, tests, and chain of custody.
Chain of Custody
Documented trail of sample possession from collection through disposal.
Stability Study
Scheduled testing of products under defined storage to establish shelf life.
Method Validation
Documented evidence that an analytical method is fit for its intended use.
Instrument Calibration
Comparison of instrument output to reference standards on a defined schedule.
Batch Release
Quality decision to approve a batch for distribution based on test and documentation review.