Glossary
Computerised System
Also writtencomputerized system
A set of software and hardware components configured to perform a particular function together.
Source · PIC/S PE 009-17, Annex 11, Principle and Glossary
Details
A computerised system is software and hardware performing a GMP function together; the application is validated and the IT infrastructure is qualified. Inspections cite the absence of an up to date system inventory, user requirements specification, data flow, or interface description, and inadequate access control, change control, and periodic review. Look at the system description, validation traceability, privileges, audit trails, backup and recovery, and records of changes, incidents, and periodic review.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
-
The critical deficiencies are related to Quality Assurance management, aseptic operations in relation to compliance with Annex I of the GMP, maintenance and cleaning of equipment and facilities, and computerised systems.
EMA · EU GMP NCR (EudraGMDP) · 2025-05-05 -
Inconsistencies were noted between system records and equipment status, including inconsistencies between computerised system records and the operational status of equipment.
EMA · EU GMP NCR (EudraGMDP) · 2026-03-10 -
Major systemic deficiencies in the areas of supplier qualification, change management, deviation management, qualification of equipment, validation of computerised systems and good documentation practice could not be resolved.
EMA · EU GMP NCR (EudraGMDP) · 2020-06-30
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
PIC/S PE 009-17, Annex 11, Principle and GlossaryGRM Regulatory Glossary
243 GMP terms in one place
Each term is explained in plain language with its official source. Look it up here whenever you meet a term you don't know.
Browse the whole glossary