HPLC and chromatography data system

A high-performance liquid chromatograph pumps a mobile phase through a column, separates the sample’s components and measures them with a detector; the chromatography data system (CDS) controls the instrument, integrates peaks and calculates results. Most assay, impurity and identity results for release come from such a system.

The instrument is qualified as laboratory equipment and the CDS validated as a computerised system: Annex 11 asks for risk-based validation, audit trails of GMP-relevant changes and deletions that are "regularly reviewed", controlled access, and data secured and backed up throughout retention (1, 4, 7, 9, 12).

Where it sits: In the quality control laboratory, and in development and in-process testing.

• —Assay and impurity testing for release and stability
• —Identity testing
• —Cleaning validation residue analysis

In the reference facility: QC analytical laboratory

Not covered on this page: Gas chromatography and mass spectrometry, which share most of the data controls; Method development and validation themselves.

• 01Pump and mobile phase delivery. Delivers flow and gradient.
• 02Autosampler. Injects samples in sequence.
• 03Column and column oven. Separates components at controlled temperature.
• 04Detector (UV, diode array, fluorescence or other). Measures the separated components.
• 05Chromatography data system. Controls acquisition, processing, reporting, audit trails and storage.

Connects to: Laboratory information management system (LIMS); Network storage and backup; Balances (sample weights); Reference standards.

• 01Chromatography performance checks. Module performance in qualification and system suitability before each run. Watch for: system suitability passed by reprocessing until it fits.
• 02Temperature sensor (RTD or thermocouple). Column oven and autosampler temperature. Watch for: sensor not at the location that matters (cold spot, load centre).

• 01System suitability result (limit, resolution or % RSD or tailing factor). Criteria defined in the validated analytical procedure for the product.
• 02Temperature (setpoint, °C). Column temperature, as the analytical procedure sets it.
• 03Audit trail record (attribute, entries per change: who, what, when, why). Generated for GMP-relevant changes and deletions with reasons, and reviewed regularly (Annex 11, 9).

SPEQ publishes no universal alarm or acceptance values: they depend on the process, the product and the site’s own qualification.

• 01Procedure: Audit trail review. Regular review of GMP-relevant changes and deletions, with reasons documented (Annex 11, 9).
• 02Interlock: Role-based access. Restricts acquisition, processing and method changes to authorised users; access changes are recorded (Annex 11, 12).
• 03Procedure: Backup and restore. Regular backups, with restore checked in validation and periodically (Annex 11, 7.2).
• 04Procedure: Periodic evaluation. Confirms the system remains in a validated state (Annex 11, 11).
• 05Procedure: Trending of results. Critical results trended and checked for consistency; out-of-trend and out-of-specification data investigated (Chapter 6, 6.9, 6.16).

An alarm asks for a response; an interlock stops an action; a safety function protects people and has its own risk basis.

• 01Instrument qualification. Installation and operational qualification of each module; Performance checks at defined intervals.
• 02CDS validation (Annex 11, 4). User requirements and risk assessment; Configuration of audit trails, access and calculations; Data migration checks where data are moved (4.8).
• 03Method validation. Validated or verified analytical procedure (Chapter 6, 6.15).
• 04Routine. System suitability per run; Audit trail review before results are approved; Records with the data Chapter 6 requires (6.17).
• 05Periodic. Periodic evaluation and access review (Annex 11, 11, 12.3).

• 01EU GMP Annex 11: Computerised Systems — European Commission (EudraLex Volume 4), 2011, in operation 30 June 2011 (revised draft consulted from 7 July 2025, not in force). European Union; in force. Supports: Risk management (1); validation (4); data storage and backups (7); audit trails (9); change management (10); periodic evaluation (11); security and access (12).
• 02EU GMP Part I, Chapter 6: Quality Control — European Commission (EudraLex Volume 4), 28 March 2014, in operation 1 October 2014. European Union; in force. Supports: Laboratory equipment (6.5, 6.6); trending (6.9, 6.16); method validation and verification (6.15); records (6.17).