This section addresses the operational programs required to maintain the validated state of analytical instruments after qualification. It explains how calibration, maintenance, and repairs interact with qualification status and how impact assessments determine when partial or full requalification is required.
1. Purpose and Scope Instrument requalification strategy defines the approach used to ensure that analytical instruments remain in a validated state throughout their lifecycle following changes, repairs, or observed performance issues. This section establishes how requalification requirements are determined, scoped,…
1. Purpose and Scope Repair impact assessment defines the structured process used to evaluate how instrument repairs affect measurement performance, data integrity, and the validated state. This section establishes how repairs are classified and how appropriate post-repair actions are determined…
1. Purpose and Scope Preventive maintenance of analytical instruments establishes a controlled approach to maintaining instrument performance, reliability, and suitability for intended use throughout the lifecycle. This section defines how maintenance activities are applied specifically to analytical instruments to support…
1. Purpose and Scope Calibration control for analytical instruments establishes documented assurance that measurement systems used in laboratory testing produce accurate, reliable, and traceable results. This section defines how calibration programs are specifically applied to analytical instruments used for product…