Computerized System Inventory
What a definition is not
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.
A maintained, organisation-wide list of every computerized system used for GxP purposes, recording each system’s intended use, GxP-impact classification, validation status, and data ownership — the baseline record inspectors typically request before assessing the validation and data integrity controls of any individual system.
Before an inspector can evaluate whether a single system is adequately validated and controlled, they usually need to see that the organisation actually knows every system it operates. The computerized system inventory is that master list — every application, instrument controller, and platform touching GxP data, in one place.
A complete inventory records, for each entry, its business owner, its GxP impact or risk category, which drives how rigorously it must be validated and how often its audit trail is reviewed, its current validation status, and whether it is a standalone system or interfaces with others.
An incomplete inventory is itself a finding — a system missing from the list has, by definition, no documented validation status or assigned owner, which is exactly the condition data integrity controls are meant to prevent.
- —A master list of every GxP computerized system in use across the organisation
- —Records intended use, GxP-impact classification, validation status, and system owner
- —A prerequisite inspectors expect before assessing any single system
- —A missing or incomplete inventory is itself treated as a data integrity gap
PIC/S PI 041-1; EU GMP Annex 11; GAMP 5
Frequently asked questions
What is Computerized System Inventory?
A maintained, organisation-wide list of every computerized system used for GxP purposes, recording each system’s intended use, GxP-impact classification, validation status, and data ownership — the baseline record inspectors typically request before assessing the validation and data integrity controls of any individual system.
Which regulations cover Computerized System Inventory?
PIC/S PI 041-1; EU GMP Annex 11; GAMP 5