Agilent Cerity NDS Pharmaceutical Data System Concepts Guide

This document is a guide to the application of Agilent's network data system in AQ/CQ pharmaceuticals, introducing the concepts and features of Cerity products.


Agilent Cerity NDS Pharmaceutical Data System Concepts Guide - cover page
Brand
Agilent
Document type
User Manual
Language
French
Pages
324
File format
PDF
File size
5.9 MB
Published
08 June, 2012
Updated
28 September, 2023
MD5 checksum
3BED8846CEFFEF21A14100DD276A80D0

About this manual

This document serves as a concepts guide for the Agilent Cerity Networked Data System (NDS), designed to help users understand the system's components and functionality within a pharmaceutical context. It details the principles of architecture, command flows, and information processing specific to the Cerity NDS.

The guide focuses heavily on data security and integrity, explaining how the system complies with FDA 21 CFR Part 11 regulations regarding electronic records and signatures, as well as Good Laboratory Practice (GLP) and cGMP rules. It covers topics ranging from basic concepts and user interface views to advanced features like data acquisition, instrument control, method management, and report generation. This manual is written in French.

What's inside

  • Architecture du système Cerity
  • Sécurité du système et intégrité des données
  • Conformité 21 CFR Part 11
  • Résistance aux pannes
  • Tracabilité et Audit
  • Concepts de base de Cerity
  • Les quatre vues (Sample, Method, Instrument, Result)
  • Acquisition des données
  • Commande des instruments
  • Traitement de données

Specifications

Practice StandardsGLP, cGMP, GMP

Frequently asked questions

What is the purpose of this guide?

To allow users to better understand the different NDS components for Pharmaceutical Cerity AQ/CQ and their operation.

Which software revision does this guide correspond to?

Revision A.02.xx, where xx indicates minor revisions greater than or equal to 02.

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