Ensuring compliance and superior data integrity for pharma and biopharma labs
Agilent Technologies has announced that the Agilent Cary 3500 UV-Vis Spectrophotometer is now compatible with the Agilent OpenLab software suite of products. The Cary 3500 UV-Vis data can now be managed, protected, and stored in a secure central database, helping to meet global regulatory requirements.
A recent pharma lab manager survey indicated that data integrity is a top concern. By offering the Cary 3500 UV-Vis system with OpenLab server software, Agilent minimises security risks while helping to preserve the integrity of the data for a GMP (good manufacturing practice) lab. This introduction provides the technical controls to acquire, process, report, and store data more securely in labs that must follow compliance guidelines of FDA CFR Part 11, or EU Annex 11, in GMP facilities, reducing the risk of GMP audit findings.
"This solution for the Cary 3500 UV-Vis adds efficiency, making it is easier to collaborate in a distributed environment," said Geoff Winkett, vice president and general manager of Agilent’s Molecular Spectroscopy Division. He continued, “It also provides a more secure solution where all systems store their data in a central location that’s backed up at the server level."
The Cary 3500 UV-Vis software is an innovative data system that can simultaneously collect the data from standards and unknowns, automatically generate a calibration curve, and determine sample concentration data in a single measurement—in less than five seconds. This efficient and automated data collection and analysis improves data quality and eliminates variability introduced during the measurement process.
The OpenLab software includes secure database storage for electronic records, complete user administration and access privileges, software licensing, and data security settings—including e-signature workflow and enhanced audit trail review capabilities. The new Cary UV Networked Workstation can be integrated into an OpenLab customer environment, making it easier to maintain multiple systems by connecting them to a single OpenLab Server.
The Cary 3500 is the most recent UV-Vis platform from Agilent. Regular hardware and software releases support this platform as it grows in strategic markets, such as pharma and biopharma. The first software release for regulated customers, Workstation Plus, was well accepted, and this release addresses customers seeking a distributed environment solution. The networked workstation is part of a unified compliance initiative that uses OpenLab software to develop all applications based on common standards.