Laboratory

Lab operations, instrumentation, and technique.

Analyst Qualification — Training and Competency Assessment

How laboratory analysts are trained and assessed as competent before performing GMP testing independently.

Data Integrity — ALCOA+ Principles for Laboratory Records

What the ALCOA+ principles mean in practice for laboratory data and records.

Laboratory Audit Trail Review — Requirements for Electronic Systems

What a compliant audit trail review process looks like for electronic laboratory systems.

Laboratory Equipment Calibration Program — Frequency and Documentation

How a lab-wide calibration program is scheduled, documented, and kept audit-ready.

Laboratory Information Management System (LIMS) — Implementation Considerations

Key considerations when implementing a LIMS in a regulated QC laboratory.

Laboratory Investigation — Phase I/II OOS Investigation Framework

A practical framework for running a two-phase OOS investigation from the lab bench through manufacturing.

Laboratory Sample Management — Chain of Custody Requirements

How chain of custody is maintained for samples from receipt through testing and disposal.

Out-of-Trend (OOT) Data — Detection and Investigation Approach

How out-of-trend results are statistically detected and investigated, distinct from OOS handling.

Reference Standard Management — Storage and Inventory Control

How reference standards are stored, tracked, and controlled to preserve their integrity over time.

Retained Sample Program — Storage Requirements and Retention Periods

What a retained/reserve sample program must maintain and for how long, by product type.