Computerised System 570 A computerised system is a function (process or operation) integrated with a computer system and 571 performed by trained personnel. The function is controlled by …

The introduction of computerised systems into systems of manufacturing, including storage, distribution and quality control does not alter the need to observe the relevant principles given …

Dec 11, 2009 · This document addresses issues pertaining to computerized systems used to create, modify, maintain, archive, retrieve, or transmit clinical data intended for submission to …

OECD ENV/JM/MONO(2016)13 – Principles of GLP: Audit trail for a computerised system should be enabled, appropriately configured and reflect the roles and responsibilities of study personnel.

The revised Annex 11 mandates that regulated users implement a comprehensive Pharmaceutical Quality System (PQS) covering all computerised systems and associated …

Before a computerised system is brought into use, it should be demonstrated, through appropriate validation or verification studies, that the system is capable of achieving the desired results …

Computerised systems used within a clinical trial should be subject to processes that confirm that the specified requirements of a computerised system are consistently fulfilled, and that the …