This document describes the different levels of instrument control with chromatography data systems and their implications for compliance. It provides a checklist for evaluating the capability of instrument control and data handling software.
The document outlines the varying degrees of control that chromatography data systems (CDS) can exert over instruments, ranging from manual setup to advanced digital integration. It explains how these different levels impact the ability to generate raw data, metadata, and audit trails required for regulatory compliance.
Four distinct levels of control are defined: Level 1 involves manual parameter setting with analog signal recording; Level 2 allows basic digital control via interfaces like RS232 or GPIB; Level 3 provides full digital instrument control including error handling and diagnostics; and Level 4 offers advanced functionality with handshake protocols for guaranteed command execution. The text also compares communication methods, specifically GPIB versus LAN (TCP/IP), regarding speed, error detection, and qualification requirements.
Level 1 is manual setup; Level 2 is basic digital control via LAN, RS232 or GPIB; Level 3 is full digital instrument control with error recording; and Level 4 includes advanced functionality like handshake protocols.
GPIB is limited to connecting up to 15 devices on a common bus.
Level 4 provides advanced functionality including handshake protocols, self-diagnostics, early maintenance feedback, and automatic tracking of serial numbers.