Chromatography Data System Controls
Chromatography Data System (CDS) Controls
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A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The specific technical and procedural controls applied to laboratory chromatography software — audit trail enabled and reviewed, restricted ability to edit integration parameters or methods, no unauthorised reprocessing, renaming, or deletion of injections — an area regulators cite repeatedly because CDS software has historically made data manipulation easy and hard to detect.
Chromatography data systems (CDS) control HPLC, GC, and similar laboratory instruments and process the resulting data — integration, calculation, reporting. Because a CDS can often reprocess a run with different integration parameters until a passing result appears, or allow an unfavourable injection to be renamed or hidden as a “test” run, it has been one of the most frequently cited data integrity risk areas in inspection findings.
Effective CDS control starts with the audit trail: it must be enabled from installation, capture every method and integration parameter change with the reason, and be reviewed as part of every batch or run release, not left switched off “to save disk space” or simply never looked at.
Beyond the audit trail, controls typically include restricting who may create or modify integration methods, preventing deletion of injections, including “trial” or “test” injections, which must be visible and accounted for rather than silently discarded, and locking or archiving a run once it has been used for a reportable result.
- —Audit trail must be enabled from installation and reviewed as part of run release
- —Integration method and parameter changes must be restricted and captured with a reason
- —No injection, including a “trial” or “test” run, may be deleted or hidden
- —A historically frequent focus of inspection data integrity findings
MHRA GXP Data Integrity Guidance (2018); FDA Data Integrity and Compliance With Drug CGMP Guidance for Industry (2018); PIC/S PI 041-1
Frequently asked questions
What does Chromatography Data System Controls stand for?
Chromatography Data System Controls stands for Chromatography Data System (CDS) Controls.
What is Chromatography Data System Controls?
The specific technical and procedural controls applied to laboratory chromatography software — audit trail enabled and reviewed, restricted ability to edit integration parameters or methods, no unauthorised reprocessing, renaming, or deletion of injections — an area regulators cite repeatedly because CDS software has historically made data manipulation easy and hard to detect.
Which regulations cover Chromatography Data System Controls?
MHRA GXP Data Integrity Guidance (2018); FDA Data Integrity and Compliance With Drug CGMP Guidance for Industry (2018); PIC/S PI 041-1