Preparing Your Analytical Laboratory for a Regulatory Audit

Flashcards covering key terms and definitions related to preparing an analytical laboratory for regulatory audits.

Regulatory Audit

An official inspection of an organization's processes and compliance with regulations.

ISO 9001

An international standard that specifies requirements for a quality management system.

Calibration

The process of adjusting the accuracy of a measuring instrument.

Validation

The process of proving that a method or system meets specified requirements.

Data Integrity

The accuracy and consistency of data stored in a database or other storage format.

CAPA

Corrective and Preventative Actions taken to rectify issues and prevent their recurrence.

GxP

Good Practice regulations and guidelines that ensure products are safe and effective.

LIMS

Laboratory Information Management System, software that manages samples and associated data.

Qualification

Establishing confidence that a system or component meets its intended requirements.

Training Record

A document that records the training provided to an individual in a specific competency.