Cerity NDS for Pharmaceutical QA/QC is a networked data system specifically designed for pharmaceutical QA/QC laboratories. It is powerful, flexible and utilizes an integrated client-server architec- ture enabling seamless industry standard distributed client-server scala- bility. Its user interface is optimized to model the way analysts work in the QA/QC environment, fully supporting their everyday tasks.
This manual describes the Agilent Cerity Networked Data System (NDS) for Pharmaceutical QA/QC, available in Professional and Client/Server configurations. The system is designed for pharmaceutical laboratories requiring instrument control, data acquisition, and analysis while adhering to 21 CFR Part 11 and related GMP regulations. The Professional version supports up to eight chromatographs controlled by a single computer for one user, whereas the Client/Server version allows multiple users to access a central database and instruments concurrently.
| Maximum instruments supported (Professional) | 8 chromatographs |
|---|---|
| Data acquisition rate | 200Hz |
| Database server | Oracle 8 |
| Operating System | Windows NT |
| Minimum CPU (Professional) | Pentium III, 600 MHz |
| Minimum Memory (Professional) | 512 MB |
| Minimum Disk Space (Professional) | 20 GB |
The system supports strict adherence to 21 CFR Part 11 (electronic records and electronic signatures) and related predicate rules such as 21 CFR 210 (GMP) and 21 CFR Part 211 (cGMP).
Supported instruments include the Agilent 1100 Series HPLC, Agilent 6890, Agilent 6850 GC, Agilent 35900E A/D, and the Waters Alliance 2690 LC with a Waters 2487 Dual Wavelength Detector.
It is a computer-based qualification utility used to perform Installation Qualification (IQ) of the Cerity NDS system to verify the completeness and intactness of the installed software.