Upgraded chromatogrpahy data system for pharmaceutical QA/QC reduces operational and validation costs through enhanced usability, instrument control, and data exchange
Agilent Technologies has announced the release of Cerity CDS A.02.03, a dedicated chromatography data system for pharmaceutical quality assurance/quality control laboratories, designed to enhance workflows and facilitate compliance of pharmaceutical QA/QC labs of all sizes.
"We've designed a complete package for today's pharmaceutical QA/QC lab that adapts easily to laboratory workflow to optimise efficiency and productivity, while also providing close integration with other internal and external systems," said Gunter Nill, general manager, pharma business, Agilent Life Sciences and Chemical Analysis.
Cerity provides centralised management of chromatography data for labs operating from just a few to hundreds of instruments.
Release A.02.03 now offers:.
Tighter integration into customers' laboratory structures and workflows, including project data organization and object level security.
Better data import/export and programmatic connectivity to external systems such as ERP, Lims, ELN and analytics.
New instrument diagnostics to enhance efficiency and productivity.
Cerity CDS significantly reduces the time spent on system qualification and validation.
It offers fully automated validation tools for analytical hardware qualification and verification, as well as software qualification.
Cerity CDS offers many features to facilitate FDA 21 CFR Part 11 compliance, including version control, inherent data integrity and an automatic, fully traceable audit trail to ensure that no records can be overwritten.
Thus, Cerity CDS assures correct and validated final results and it produces final results faster than any other packages not tailored to the regulated pharmaceutical laboratory environment.
It provides for level-4 instrument control, including the highest level security features such as active handshake, error checking, automated tracking of serial numbers and firmware revisions, and advanced diagnostics.
This means that records of instrument and data acquisition are reliable and trustworthy, according to current 21 CFR Part 11 guidelines.
Cerity A.02.03 scales up seamlessly from standalone, single-user configurations to distributed multi-user, multi-instrument configurations for labs with 100 instruments or more.
It's based on industry-standard software and protocols, minimising demands on IT.
The built-in spreadsheet/custom calculator eliminates time-consuming, error-prone manual data transcription.
"We're protecting customers' investments in Cerity for pharmaceutical QA/QC by building on technology such as instrument control through Lan or Oracle-based data management," Nill added.
"Cerity CDS for pharmaceutical QA/QC also provides for integration of leading-edge technologies".
Customers with a current Agilent support contract will receive a free upgrade to Cerity CDS A.02.03 software.
