Αποτελέσματα Αναζήτησης
A4.2 Physical security. Computerised systems, servers, communication infrastructure and media containing clinical trial data should be protected against physical damage, unauthorised physical access, and unavailability. The extent of security measures depends on the criticality of the data.
The computerised system consists of the hardware, software, and network components, together with the controlled functions and associated documentation.
By routine verification of data and system logs at fixed intervals (checks, audits) (see topic: Maintenance of Validated Status). By studying validation through the installation of testing protocols, operation and system performance (see topic: How to validate computerized systems?).
13 Ιουλ 2023 · EU Annex 11 outlines requirements for using computerized systems in the Life Science industries operating within the European Union. It is a guidance document for interpreting the principles of good manufacturing practice (GMP) for medicinal products.
If a computerized system being used for the clinical study is part of a system normally used for other purposes, efforts should be made to ensure that the study software is logically and ...
16 Φεβ 2022 · In a GxP environment , computerized systems cover a broad spectrum with examples including clinical trials data management, manufacturing resource planning, laboratory information management, process control network, manufacturing execution, document management, or automated laboratory equipment.
of computerised systems to establish quality assurance systems and records capable of demonstrating compliance with current GxP requirements and related guidance.
