s1 NDS Cerity is a QA/QC system for the pharmaceutical industry
This document serves as a concept guide for the Agilent NDS Cerity system, designed for pharmaceutical Quality Assurance and Quality Control (QA/QC) applications. It provides a general overview of the system's design principles, behavior, and information flow, with a specific focus on data security and integrity as required by regulations such as 21 CFR Part 11 of the FDA and common standards like GMP, cGMP, and GLP.
The guide covers fundamental concepts including system architecture, user interface windows, data acquisition, instrument control, and data processing methods. It details how to work with Cerity methods, perform data integration and peak identification, and generate reports. Additionally, it addresses system administration, audit trails, electronic signatures, and error resilience features like data buffering and clustering. This manual is written in Italian.
The system is designed for QA/QC in the pharmaceutical field.
The system complies with 21 CFR Part 11 of the FDA regarding electronic records and signatures.